Schedule 1—Specified permissible ingredients and requirements applying to these ingredients when contained in a medicine

Note: See sections 5, 6 and 6A.

Permissible ingredients and requirements
Column 1	Column 2	Column 3	Column 4
Item	Ingredient Name	Purpose	Specific requirements
3642	P-ALPHA-DIMETHYL STYRENE	E	Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.
3643	P-ANISIC ACID	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye or on damaged skin. The concentration in the medicine must be no more than 0.3%.
3644	PADIMATE O	A	Only for use as an active ingredient in sunscreens for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must not be more than 8%. When used in primary sunscreen products, the following warning statements are required on the label: - (AVOID) 'Avoid prolonged exposure in the sun' (or words to this effect); and - (SUNPRO) 'Wear protective clothing - hats and eyewear when exposed to the sun' (or words to this effect).
3645	PADINA PAVONICA THALLUS PHYTOSTEROLS	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.01%.
3646	PAEONIA LACTIFLORA	A, E, H
3647	PAEONIA OBOVATA	A, H
3648	PAEONIA SUFFRUTICOSA	A, E, H
3649	PAEONIA VEITCHII	A, H
3650	PALIURUS SPINA-CHRISTI	A, H
3651	PALLADIUM	H	Only for use as an active homoeopathic ingredient.
3652	PALM FRUIT OIL	A, E, H
3653	PALM GLYCERIDES	E
3654	PALM KERNEL OIL	A, E, H
3655	PALM TOCOTRIENOLS COMPLEX	A, H
3656	PALMARIA PALMATA	A, H
3657	PALMAROSA OIL	A, E, H
3658	PALMIDROL	A	Only permitted for use in medicines limited to oral routes of administration. The maximum recommended daily dose of the medicine must not provide more than 600 mg of palmidrol. The following warning statements (or words to the same effect) are required on the medicine label: - (ANALG) 'The medicine may interact with other prescription analgesic medicines, please consult your healthcare practitioner before use.' - (ADULT) ‘Adults only.’ - (21DAYS) ‘Not to be used for more than 21 consecutive days.’
3659	PALMITIC ACID	E
3660	PALMITOLEIC ACID-RICH FATTY ACID ETHYL ESTERS	A
3661	PALMITOYL DIPEPTIDE-7	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.002%.
3662	PALMITOYL HYDROXYPROPYLTRIMONIUM AMYLOPECTIN/GLYCERIN CROSSPOLYMER	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.01%
3663	PALMITOYL OLIGOPEPTIDE	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.002%.
3664	PALMITOYL PENTAPEPTIDE-3	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.0005%.
3665	PALMITOYL TETRAPEPTIDE-3	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.001%.
3666	PANAX GINSENG	A, E, H
3667	PANAX JAPONICUS	A, H
3668	PANAX NOTOGINSENG	A, H
3669	PANAX PSEUDOGINSENG	A, H
3670	PANAX QUINQUEFOLIUS	A, H
3671	PANICUM MILIACEUM	A, H
3672	PANTETHINE	E	Only for use in topical medicines for dermal application.
3673	PANTHENOL	A, E
3674	PANTHENYL ETHYL ETHER	E	Only for use in topical medicines for dermal application.
3675	PANTOLACTONE	E
3676	PANTOTHENIC ACID	A, E	When used topically, the concentration in the medicine must be no more than 0.1%.
3677	PANTOTHENIC ACID POLYPEPTIDE	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.1%.
3678	PAPAIN	A, E
3679	PAPER	E	Only for use in topical medicines for dermal application.
3680	PAPRIKA OLEORESIN	E	Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
3681	PARA-CRESOL	E	Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.
3682	PARA-CRESYL ACETATE	E	Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.
3683	PARA-CRESYL ISOBUTYRATE	E	Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.
3684	PARA-CRESYL PHENYLACETATE	E	Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.
3685	PARA-CYMENE	E	Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.
3686	PARA-ETHOXYBENZALDEHYDE	E	Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
3687	PARA-ETHYL CRESOXYACETATE	E	Para-ethyl cresoxyacetate must only be included in medicines when in combination with other permitted ingredients as a fragrance proprietary excipient formulation. The total concentration of the fragrance proprietary excipient formulation containing para-ethyl cresoxyacetate must not be more than 1% of the total medicine.
3688	PARA-ETHYLPHENOL	E	Permitted for use only in combination with other permitted ingredients as part of a flavour proprietary excipient formulation. The maximum recommended daily dose must contain no more than 0.12 mg of para-ethylphenol. The total flavour proprietary excipient formulation in a medicine must be no more than 5%.
3689	PARA-HYDROXY BENZALACETONE	E	Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.
3690	PARA-HYDROXYBENZOIC ACID	E
3691	PARA-MENTHA-8-THIOL-3-ONE	E	Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.
3692	PARA-METHYL ACETOPHENONE	E	Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.
3693	PARA-METHYL ANISOLE	E	Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.
3694	PARA-METHYL DIMETHYLBENZYL CARBINOL	E	Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.
3695	PARA-PROPYL ANISOLE	E	Para-propyl anisole must only be included in medicines when in combination with other permitted ingredients as a fragrance and/or flavour proprietary excipient formulation. The total concentration of fragrance proprietary excipient formulations containing para-propyl anisole must not be more than 1% of the total medicine. The total concentration of flavour proprietary excipient formulations containing para-propyl anisole must not be more than 5% of the total medicine.
3696	PARA-TERT-BUTYLCYCLOHEXYL ACETATE	E	Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.
3697	PARA-TERT-BUTYLPHENYL-ALPHA-METHYLHYDROCINNAMIC ALDEHYDE	E	Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.
3698	PARA-TOLUALDEHYDE	E	Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.
3699	PARA-TOLYL ACETALDEHYDE	E	Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.
3700	PARAMERIA LAEVIGATA	A, H
3701	PARIETARIA JUDAICA	A, H
3702	PARIS POLYPHYLLA	A, H
3703	PARIS QUADRIFOLIA	A, H
3704	PARSLEY HERB DRY	A, E, H	The requirements specified below apply to a medicine that contains the ingredient that is: - listed in the Register on or after 1 March 2025; or - released for supply on or after 1 March 2026. The following warning statement is required on the medicine label: - (PREGNT2) ‘Do not use if pregnant or likely to become pregnant.’ unless when: (a) parsley herb dry is used as an active homoeopathic ingredient at a homoeopathic potency of more than 12X; or (b) parsley herb dry is used as an excipient in a flavour where the total concentration of flavour proprietary excipient formulations containing parsley herb dry must not be more than 5% of the total medicine; or (c) parsley herb dry is used as an excipient in a fragrance where the total concentration of fragrance proprietary excipient formulations containing parsley herb dry must not be more than 1% of the total medicine.
3705	PARSLEY HERB OIL	A, E, H	The requirements specified below apply to a medicine that contains the ingredient that is: - listed in the Register on or after 1 March 2025; or - released for supply on or after 1 March 2026. The following warning statement is required on the medicine label: - (PREGNT2) ‘Do not use if pregnant or likely to become pregnant.’ unless when: (a) parsley herb oil is used as an active homoeopathic ingredient at a homoeopathic potency of more than 12X; or (b) parsley herb oil is used as an excipient in a flavour where the total concentration of flavour proprietary excipient formulations containing parsley herb oil must not be more than 5% of the total medicine; or (c) parsley herb oil is used as an excipient in a fragrance where the total concentration of fragrance proprietary excipient formulations containing parsley herb oil must not be more than 1% of the total medicine.
3706	PARSLEY HERB POWDER	A, E, H	The requirements specified below apply to a medicine that contains the ingredient that is: - listed in the Register on or after 1 March 2025; or - released for supply on or after 1 March 2026. The following warning statement is required on the medicine label: - (PREGNT2) ‘Do not use if pregnant or likely to become pregnant.’ unless when: (a) parsley herb powder is used as an active homoeopathic ingredient at a homoeopathic potency of more than 12X; or (b) parsley herb powder is used as an excipient in a flavour where the total concentration of flavour proprietary excipient formulations containing parsley herb powder must not be more than 5% of the total medicine; or (c) parsley herb powder is used as an excipient in a fragrance where the total concentration of fragrance proprietary excipient formulations containing parsley herb powder must not be more than 1% of the total medicine.
3707	PARSLEY SEED OIL	A, E, H	The requirements specified below apply to a medicine that contains the ingredient that is: - listed in the Register on or after 1 March 2025; or - released for supply on or after 1 March 2026. The following warning statement is required on the medicine label: - (PREGNT2) ‘Do not use if pregnant or likely to become pregnant.’ unless when: (a) parsley seed oil is used as an active homoeopathic ingredient at a homoeopathic potency of more than 12X; or (b) parsley seed oil is used as an excipient in a flavour where the total concentration of a flavour proprietary excipient formulations containing parsley seed oil must not be more than 5% of the total medicine; or (c) parsley seed oil is used as an excipient in a fragrance where the total concentration of fragrance excipient formulations containing parsley seed oil must not be more than 1% of the total medicine.
3708	PARTHENOCISSUS TRICUSPIDATA	A, H
3709	PARTIALLY DEHYDRATED LIQUID SORBITOL	E	Sorbitol is a mandatory component of partially dehydrated liquid sorbitol. Permitted for use only as part of the capsule in medicines where the dosage form is a soft capsule.
3710	PARTIALLY HYDROGENATED SOYA OIL	E	Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in the medicine must be no more than 5%.
3711	PARTIALLY REFINED PORPHYRA YEZOENSIS CYTOPLASM EXTRACT	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.00002%.
3712	PASPALUM NOTATUM	A, H
3713	PASSIFLORA CAERULEA	A, H
3714	PASSIFLORA EDULIS	E
3715	PASSIFLORA HERB DRY	A, H
3716	PASSIFLORA INCARNATA	A, E, H
3717	PATCHOULI OIL	E	Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.
3718	PATENT BLUE V	E	Permitted for use only as a colour in medicines limited to topical and oral routes of administration.
3719	PATENT BLUE V ALUMINIUM LAKE	E	Permitted for use only as a colour in medicines limited to topical and oral routes of administration.
3720	PATRINIA SCABIOSIFOLIA	A, H
3721	PATRINIA VILLOSA	A, H
3722	PAULLINIA CUPANA	A, E, H	Caffeine is a mandatory component of Paullinia cupana. When the medicine is packaged for supply as a divided preparation and is for internal use or oral application, the medicine must not contain a concentration of total caffeine greater than 33%. When for internal use or oral application, the maximum recommended daily dose of the medicine must provide no more than 400 mg of total caffeine. When the medicine is packaged for supply as an undivided preparation and is for internal use or oral application, the medicine must not contain a concentration of total caffeine greater than 1%. When the medicine is for internal use or oral application, a maximum recommended dose of the medicine must not provide more than 100 mg of total caffeine within a 3 hour period. When the maximum recommended daily dose of the medicine provides greater than 10 mg of total caffeine and the medicine is for internal use or oral application, the following warning statements are required on the label: - (ADULT) 'Adults only' (or words to that effect). - (CAFF) 'Contains [state quantity per dosage unit or per mL or per gram of product] total caffeine [per dosage unit or per mL or per gram]. A cup of instant coffee contains approximately 80mg of caffeine.' - (CAFFPREG) ‘Caffeine intake more than 200 mg per day is not recommended during pregnancy or breastfeeding.’ When the maximum recommended daily dose of the medicine provides greater than 80 mg of total caffeine and the medicines is for internal use or oral application, the following warning statements are required on the label: - (CAFFLMT) 'Limit the use of caffeine-containing products (including tea and coffee) when taking this product.' - (CAFFCYP) ‘Caffeine interacts with enzyme CYP1A2 in the liver. Consult your health professional before taking with other medicines’ (or words to that effect).
3723	PAULLINIA PINNATA	A, H
3724	PAWPAW	E
3725	PEA	E
3726	PEA STARCH	E
3727	PEACH	E
3728	PEAR	E
3729	PECAN	E
3730	PECTIN	A, E
3731	PEDIOCOCCUS PENTOSACEUS	A	Until 19 September 2027, Pediococcus pentosaceus must only be used in a medicine where: (a) AB-Biotics SA (Client ID 80529) is the sponsor of the medicine (the primary sponsor); or (b) another person is the sponsor of the medicine (the secondary sponsor) and the TGA has been notified that the secondary sponsor has been authorised by the primary sponsor to use the ingredient in the medicine. Only permitted for use in medicines: (a) limited to oral routes of administration; and (b) when the strain of Pediococcus pentosaceus is confirmed to be Colección Española de Cultivos Tipo (CECT) accession number 8330. The strain of Pediococcus pentosaceus must be declared on the label. The maximum recommended daily dose of the medicine must not provide more than 0.5 billion cfu of Pediococcus pentosaceus. The recommended duration of use for a medicine containing Pediococcus pentosaceus must be limited to 21 days or less. Medicines that contain Pediococcus pentosaceus must only be indicated for use in individuals aged 2 weeks and older. The following warning statements (or words to the same effect) must be included on the medicine label: - (ANTIBI2) ‘Consult your health professional before taking this medicine with antibiotics’; and - (IMMUNO2) ‘May not be suitable for someone taking immunomodulators. Consult your health professional before taking with other medicines’.
3732	PEG-10 DIMETICONE	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye or damaged skin. The concentration in the medicine must be no more than 4.0%.
3733	PEG-10 SOYA STEROL	E	Only for use in topical medicines for dermal application.
3734	PEG-100 STEARATE	E	Only for use in topical medicines for dermal application.
3735	PEG-12 DILAURATE	E
3736	PEG-12 DIMETICONE/PPG-20 CROSSPOLYMER	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye or on damaged skin. The concentration in the medicine must be no more than 2%.
3737	PEG-120 METHYL GLUCOSE DIOLEATE	E	Only for use in topical medicines for dermal application.
3738	PEG-120 STEARATE	E	Only for use in topical medicines for dermal application.
3739	PEG-15 COCAMINE	E	Only for use in topical medicines for dermal application.
3740	PEG-150 DISTEARATE	E	Only for use in topical medicines for dermal application.
3741	PEG-20 ALMOND GLYCERIDES	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.5%.
3742	PEG-20 METHYL GLUCOSE DISTEARATE	E	Only for use in topical medicines for dermal application.
3743	PEG-20 METHYL GLUCOSE SESQUISTEARATE	E	Only for use in topical medicines for dermal application.
3744	PEG-20 SORBITAN ISOSTEARATE	E	Only for use in topical medicines for dermal application.
3745	PEG-20 STEARATE	E	Only for use in topical medicines for dermal application.
3746	PEG-25 PABA	A	Only for use as an active ingredient in sunscreens for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must not be more than 10%. When used in primary sunscreen products, the following warning statements are required on the label: - (AVOID) 'Avoid prolonged exposure in the sun' (or words to this effect); and - (SUNPRO) 'Wear protective clothing - hats and eyewear when exposed to the sun' (or words to this effect).
3747	PEG-30 DIPOLYHYDROXYSTEARATE	E	Only for use in topical medicines for dermal application.
3748	PEG-30 STEARATE	E	Only for use in topical medicines for dermal application.
3749	PEG-35 CASTOR OIL	E
3750	PEG-4 DILAURATE	E	Only for use in topical medicines for dermal application.
3751	PEG-4 LAURATE	E	Only for use in topical medicines for dermal application. Dioxane and Ethylene oxide are mandatory components of PEG-4 laurate. The concentration of Dioxane in the medicine must be no more than 10 mg/kg or 10 mg/L or 0.001%. The concentration of Ethylene oxide in the medicine must be no more than 1 mg/kg or 1 mg/L or 0.0001%.
3752	PEG-4 STEARATE	E	Only for use in topical medicines for dermal application.
3753	PEG-40 CASTOR OIL	E
3754	PEG-40 HYDROGENATED CASTOR OIL	E
3755	PEG-40 SORBITAN DIISOSTEARATE	E	Only for use in topical medicines for dermal application. Dioxane and Ethylene oxide are mandatory components of PEG-40 sorbitan diisostearate. The concentration of Dioxane in the medicine must be no more than 10 mg/kg or 10 mg/L or 0.001%. The concentration of Ethylene oxide in the medicine must be no more than 1 mg/kg or 1 mg/L or 0.0001%.
3756	PEG-40 STEARATE	E	Only for use in topical medicines for dermal application.
3757	PEG-45/DODECYL GLYCOL COPOLYMER	E	Only for use in topical medicines for dermal application.
3758	PEG-5 GLYCERYL STEARATE	E	Only for use in topical medicines for dermal application.
3759	PEG-50 STEARATE	E	Only for use in topical medicines for dermal application.
3760	PEG-55 PROPYLENE GLYCOL OLEATE	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.6%.
3761	PEG-6 LAURAMIDE	E	Only for use in topical medicines for dermal application.
3762	PEG-60 ALMOND GLYCERIDES	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration when used in medicines applied directly to the skin must be no more than 10%. The concentration when used in bath oil medicines must be no more than 30%.
3763	PEG-60 GLYCERYL ISOSTEARATE	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 2%.
3764	PEG-60 HYDROGENATED CASTOR OIL	E	Only for use in topical medicines for dermal application.
3765	PEG-7 COCAMIDE	E	Only for use in topical medicines for dermal application.
3766	PEG-7 GLYCERYL COCOATE	E	Only for use in topical medicines for dermal application.
3767	PEG-7 HYDROGENATED CASTOR OIL	E	Only for use in topical medicines for dermal application.
3768	PEG-75 LANOLIN	E	Only for use in topical medicines for dermal application.
3769	PEG-75 STEARATE	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 1.5%.
3770	PEG-8 CETYL DIMETHICONE	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.0005%.
3771	PEG-8 DILAURATE	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 4%.
3772	PEG-8 DISTEARATE	E	Only for use in topical medicines for dermal application.
3773	PEG-8 LAURATE	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 4%. The levels of possible impurities such as ethylene oxide (and related material) must be kept below the level of detection.
3774	PEG-8 PROPYLENE GLYCOL COCOATE	E
3775	PEG-8 STEARATE	E	Only for use in topical medicines for dermal application.
3776	PEG-9 POLYDIMETHYLSILOXYETHYL DIMETICONE	E	Only for use in topical medicines for dermal application and not to be included in medicines for use in the eye or on damaged skin. The concentration in the medicine must be no more than 3.5%.
3777	PEG/PPG-14/7 DIMETHYL ETHER	E	Only for use in topical medicines for dermal application and not to be included in medicines for use in the eye or on damaged skin. The concentration in the medicine must be no more than 7%.
3778	PEG/PPG-18/18 DIMETHICONE	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 5%.
3779	PELARGONIUM GRAVEOLENS	A, E, H
3780	PELLITORINE	E	Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
3781	PELTIGERA CANINA	A, H
3782	PENICILLIUM EXPANSUM	A, H
3783	PENNYROYAL OIL	E	D-Pulegone/Pulegone is a mandatory component of Pennyroyal Oil. The concentration of D Pulegone/ Pulegone in the medicine must be no more than 4%. Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in the medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in the medicine must be no more than 1%. When the medicine is for a use other than topical, the maximum recommended daily dose must be no more than 50 mg of Pennyroyal Oil.
3784	PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.018%
3785	PENTAERYTHRITYL TETRAISOSTEARATE	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 61%.
3786	PENTAERYTHRITYL TETRALAURATE	E	Only for use in topical medicines for dermal application. The concentration in the medicine must be no more than 80%.
3787	PENTAMETHYLHEPTENONE	E	Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.
3788	PENTANE	E	Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.
3789	PENTASODIUM ETHYLENEDIAMINE TETRAMETHYLENE PHOSPHONATE	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.1%.
3790	PENTYLENE GLYCOL	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 5%.
3791	PEPPER BLACK	E, H
3792	PEPPER OIL TERPENELESS	E	Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.
3793	PEPPERMINT AMERICAN EXT.	E	Menthol is a mandatory component of peppermint american ext. When the medicine is for topical use for dermal application: a) the medicine must not be intended for use in the eye or on damaged skin; b) the medicine must not deliver more than 25% total menthol when administered according to the directions for use; c) the following warning statement is required on the medicine label: - (EYE) Avoid contact with eyes (or words to that effect). d) if the medicine delivers more than 1% total menthol when administered according to the directions for use, the following warning statements are required on the medicine label: - (SKTEST) If you have sensitive skin, test this product on a small area of skin before applying it to a large area; - (IRRIT) If irritation develops, discontinue use. e) if the medicine delivers more than 5% total menthol when administered according to the directions for use, the following warning statement is required on the medicine label: – (MENTH) Contains a high concentration of menthol, which can cause severe skin irritation. When the medicine is for internal use, the maximum recommended daily dose must not contain more than 1 gram of menthol.
3794	PEPPERMINT LEAF DRY	A, E, H	Menthol is a mandatory component of peppermint leaf dry. When the medicine is for topical use for dermal application: (i) the medicine must not be intended for use in the eye or on damaged skin; (ii) the medicine must not deliver more than 25% total menthol when administered according to the directions for use; (iii) the following warning statement is required on the medicine label: - (EYE) Avoid contact with eyes (or words to that effect). (iv) if the medicine delivers more than 1% total menthol when administered according to the directions for use, the following warning statements are required on the medicine label: - (SKTEST) If you have sensitive skin, test this product on a small area of skin before applying it to a large area; - (IRRIT) If irritation develops, discontinue use. (v) if the medicine delivers more than 5% total menthol when administered according to the directions for use, the following warning statement is required on the medicine label: – (MENTH) Contains a high concentration of menthol, which can cause severe skin irritation. When the medicine is for internal use, the maximum recommended daily dose must not contain more than 1 gram of menthol.
3795	PEPPERMINT LEAF POWDER	A, E, H	Menthol is a mandatory component of peppermint leaf powder. When the medicine is for topical use for dermal application: (i) the medicine must not be intended for use in the eye or on damaged skin; (ii) the medicine must not deliver more than 25% total menthol when administered according to the directions for use; (iii) the following warning statement is required on the medicine label: - (EYE) Avoid contact with eyes (or words to that effect). (iv) if the medicine delivers more than 1% total menthol when administered according to the directions for use, the following warning statements are required on the medicine label: - (SKTEST) If you have sensitive skin, test this product on a small area of skin before applying it to a large area; - (IRRIT) If irritation develops, discontinue use. (v) if the medicine delivers more than 5% total menthol when administered according to the directions for use, the following warning statement is required on the medicine label: – (MENTH) Contains a high concentration of menthol, which can cause severe skin irritation. When the medicine is for internal use, the maximum recommended daily dose must not contain more than 1 gram of menthol.
3796	PEPPERMINT OIL	A, E, H	Menthol is a mandatory component of peppermint oil. When the medicine is for topical use for dermal application: (i) the medicine must not be intended for use in the eye or on damaged skin; (ii) the medicine must not deliver more than 25% total menthol when administered according to the directions for use; (iii) the following warning statement is required on the medicine label: - (EYE) Avoid contact with eyes (or words to that effect). (iv) if the medicine delivers more than 1% total menthol when administered according to the directions for use, the following warning statements are required on the medicine label: - (SKTEST) If you have sensitive skin, test this product on a small area of skin before applying it to a large area; - (IRRIT) If irritation develops, discontinue use. (v) if the medicine delivers more than 5% total menthol when administered according to the directions for use, the following warning statement is required on the medicine label: – (MENTH) Contains a high concentration of menthol, which can cause severe skin irritation. When the medicine is for internal use, the maximum recommended daily dose must not contain more than 1 gram of menthol.
3797	PEPPERMINT OIL TERPENELESS	E	Permitted for use only in combination with other permitted ingredients as a flavour proprietary excipient formulation or fragrance proprietary excipient formulation. The total flavour proprietary excipient formulation in a medicine must be no more than 5%. The total fragrance proprietary excipient formulation in a medicine must be no more 1%. Menthol is a mandatory component of peppermint oil terpeneless. When the medicine is for topical use for dermal application: i) the medicine must not be intended for use in the eye or on damaged skin; ii) the medicine must not deliver more than 25% total menthol when administered according to the directions for use; iii) the following warning statement is required on the medicine label: - (EYE) Avoid contact with eyes (or words to that effect). iv) if the medicine delivers more than 1% total menthol when administered according to the directions for use, the following warning statements are required on the medicine label: - (SKTEST) If you have sensitive skin, test this product on a small area of skin before applying it to a large area; - (IRRIT) If irritation develops, discontinue use. v) if the medicine delivers more than 5% total menthol when administered according to the directions for use, the following warning statement is required on the medicine label: – (MENTH) Contains a high concentration of menthol, which can cause severe skin irritation. When the medicine is for internal use, the maximum recommended daily dose must not contain more than 1 gram of menthol.
3798	PEPPERMINT OIL TERPENES AND TERPENOIDS	E	Permitted for use only in combination with other permitted ingredients as a flavour proprietary excipient formulation. The total flavour proprietary excipient formulation in a medicine must be no more than 5%. Menthol is a mandatory component of peppermint oil terpenes and terpenoids. When the medicine is for topical use for dermal application: i) the medicine must not be intended for use in the eye or on damaged skin; ii) the medicine must not deliver more than 25% total menthol when administered according to the directions for use; iii) the following warning statement is required on the medicine label: - (EYE) Avoid contact with eyes (or words to that effect). iv) if the medicine delivers more than 1% total menthol when administered according to the directions for use, the following warning statements are required on the medicine label: - (SKTEST) If you have sensitive skin, test this product on a small area of skin before applying it to a large area; - (IRRIT) If irritation develops, discontinue use. v) if the medicine delivers more than 5% total menthol when administered according to the directions for use, the following warning statement is required on the medicine label: – (MENTH) Contains a high concentration of menthol, which can cause severe skin irritation. When the medicine is for internal use, the maximum recommended daily dose must not contain more than 1 gram of menthol.
3799	PERFLUOROPOLYMETHYLISOPROPYL ETHER	E	Only for use in topical medicines for dermal application.
3800	PERHYDRO-3,6-DIMETHYL-BENZO [B] FURAN-2-ONE	E	Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.
3801	PERILLA FRUTESCENS	A, E, H
3802	PERILLALDEHYDE	E	Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.
3803	PERLITE	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 2%.
3804	PERMETHRIN	E	The total concentration of permethrin in the medicine must not be more than 2%.
3805	PERSEA AMERICANA	A, E, H
3806	PERSIC OIL	A, E, H	Amygdalin and hydrocyanic acid are mandatory components of Persic oil. The concentration of amygdalin in the medicine must not be more than 10 mg/kg. The concentration of hydrocyanic acid in the medicine must not be more than 10 mg/kg.
3807	PERSICARIA CHINENSIS	A, H
3808	PERSICARIA TINCTORIA	A, H
3809	PERU BALSAM	A, E, H
3810	PERU BALSAM OIL	A, E, H
3811	PETITGRAIN MANDARIN OIL	E	Permitted for use only in combination with other permitted ingredients as a flavour The final concentration of the oil in the flavour does not exceed 30% If used in a flavour the total flavour concentration in a medicine must be no more than 5%
3812	PETITGRAIN OIL	E	Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.
3813	PETITGRAIN OIL CITRONNIER	E	Permitted for use only in combination with other permitted ingredients as part of a fragrance proprietary excipient formulation. When included in a medicine for use on the lips the concentration of petitgrain oil citronnier must be no more than 0.1%. When included in dermal creams for infant use the concentration of petitgrain oil citronnier must be no more than 0.5% The total fragrance proprietary excipient formulation in a medicine must be no more than 1%.
3814	PETITGRAIN OIL PARAGUAY	A, E, H	When used internally, oxedrine is a mandatory component of petitgrain oil paraguay. The quantity of oxedrine in the maximum recommended daily dose must be no more than 30 milligrams.
3815	PETITGRAIN OIL TERPENELESS	E	Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.
3816	PETROSELINUM CRISPUM	A, E, H	The requirements specified below apply to a medicine that contains the ingredient that is: - listed in the Register on or after 1 March 2025; or - released for supply on or after 1 March 2026. The following warning statement is required on the medicine label: - (PREGNT2) ‘Do not use if pregnant or likely to become pregnant.’ unless when: (a) Petroselinum crispum is used as an active homoeopathic ingredient at a homoeopathic potency of more than 12X; or (b) Petroselinum crispum is used as an excipient where the total concentration of flavour proprietary excipient formulations containing Petroselinum crispum must not be more than 5% of the total medicine; or (c) Petroselinum crispum is used as an excipient in a fragrance where the total concentration of fragrance proprietary excipient formulations containing Petroselinum crispum must not be more than 1% of the total medicine.
3817	PEUCEDANUM PRAERUPTORUM	A, E, H
3818	PEUMUS BOLDUS	A, H	Volatile oil components (of Peumus boldus) is a mandatory component. The maximum recommended daily dose must be no more than 100 mg of volatile oil components (of Peumus boldus).
3819	PHALARIS ARUNDINACEA	A, H
3820	PHALARIS CANARIENSIS	A, H
3821	PHASEOLUS COCCINEUS	A, H
3822	PHASEOLUS VULGARIS	A, H
3823	PHELLINUS ROBINIAE	A, E, H
3824	PHELLODENDRON AMURENSE	A, E, H
3825	PHELLODENDRON CHINENSE	A, H
3826	PHENACETIN	E	Only for use in topical medicines for dermal application. The concentration in the medicine must be no more than 0.1%.
3827	PHENETHYL 2-METHYLBUTYRATE	E	Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.
3828	PHENETHYL ACETATE	E	Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.
3829	PHENETHYL ALCOHOL	E	Permitted for use only: a) in topical medicines for dermal application; and b) for internal use in combination with other permitted ingredients as part of a flavour proprietary excipient formulation. The total flavour proprietary excipient formulation concentration in a medicine must be no more than 5%.
3830	PHENETHYL BENZOATE	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 6%.
3831	PHENETHYL DIMETHICONE	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.2%
3832	PHENETHYL ISOAMYL ETHER	E	Permitted for use only in combination with other permitted ingredients as a fragrance. If used as in a fragrance the total fragrance concentration in a medicine must be no more than 1%.
3833	PHENETHYL ISOBUTYRATE	E	Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.
3834	PHENETHYL ISOVALERATE	E	Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.
3835	PHENETHYL PHENYLACETATE	E	Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.
3836	PHENETHYL SALICYLATE	E	Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.
3837	PHENOL	E	Only for use in topical medicines for dermal application. The concentration of phenol in the medicine must be no more than 1%.
3838	PHENOXYACETALDEHYDE	E	Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.
3839	PHENOXYETHANOL	E	The requirements specified in paragraphs (a) to (b) below apply to a medicine that contains the ingredient that is: - listed in the Register before 1 March 2025; and - released for supply before 1 March 2026. (a) Only for use in topical medicines for dermal application. (b) The concentration of phenoxyethanol in the preparation must not exceed 15%. The requirements specified in paragraphs (c) to (d) below apply to a medicine that contains the ingredient that is: - listed in the Register on or after 1 March 2025; or - released for supply on or after 1 March 2026. (c) Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. (d) The concentration of phenoxyethanol in the preparation must not exceed 1%.
3840	PHENOXYETHYL ISOBUTYRATE	E	Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.
3841	PHENOXYETHYLPARABEN	E	Only for use in topical medicines for dermal application.
3842	PHENYL DIMETHICONE	E	Only for use in topical medicines for dermal application.
3843	PHENYL TRIMETHICONE	E	Only for use in topical medicines for dermal application.
3844	PHENYLACETALDEHYDE	E	Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.
3845	PHENYLACETALDEHYDE DIMETHYL ACETAL	E	Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.
3846	PHENYLACETALDEHYDE GLYCERYLACETAL	E	Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.
3847	PHENYLACETIC ACID	E	Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.
3848	PHENYLALANINE	A, E	When the maximum recommended daily dose of the medicine provides more than 500 mg phenylalanine, the following warning statement is required on the medicine label: - (PREGNT2) 'Do not use if pregnant or likely to become pregnant'.
3849	PHENYLBENZIMIDAZOLE SULFONIC ACID	A	Only for use as an active ingredient in sunscreens for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must not be more than 4%. When used in primary sunscreen products, the following warning statements are required on the label: - (AVOID) 'Avoid prolonged exposure in the sun' (or words to this effect); and - (SUNPRO) 'Wear protective clothing - hats and eyewear when exposed to the sun' (or words to this effect).
3850	PHENYLETHYL BUTYRATE	E	Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
3851	PHENYLETHYL CAPROATE	E	Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.
3852	PHENYLETHYL CAPRYLATE	E	Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.
3853	PHENYLETHYL CINNAMATE	E	Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.
3854	PHENYLETHYL FORMATE	E	Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.
3855	PHENYLETHYL METHYLETHYL CARBINOL	E	Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
3856	PHENYLETHYL PROPIONATE	E	Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.
3857	PHENYLETHYL TIGLATE	E	Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.
3858	PHENYLISOPROPYL DIMETICONE	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 5%.
3859	PHENYLPROPANOL	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.16%.
3860	PHLEUM PRATENSE	A, H	Only permitted in preparations other than phleum pratense pollen extract.
3861	PHLOXINE B	E	Permitted for use only as a colour in medicines limited to topical and oral routes of administration.
3862	PHLOXINE B ALUMINIUM LAKE	E	Permitted for use only as a colour in medicines limited to topical and oral routes of administration.
3863	PHOENIX DACTYLIFERA	A, E, H
3864	PHOSPHATIDYL CHOLINE	E
3865	PHOSPHOLIPIDS	E	Only for use in topical medicines for dermal application and not intended for use in the eye. The concentration in the medicine must be no more than 20%.
3866	PHOSPHORIC ACID	E, H	The concentration in liquid medicines must be no more than 15%.
3867	PHOSPHORUS	H	Only for use as an active homoeopathic ingredient. The total concentration of phosphorus in the medicine must not be more than 1 mg/kg or 1 mg/L or 0.0001%.
3868	PHOTINIA SERRULATA	A, H
3869	PHRAGMITES AUSTRALIS	A, H
3870	PHYLLANTHUS AMARUS	A, H
3871	PHYLLANTHUS EMBLICA	A, E, H	When used as an excipient, only for use in topical medicines for dermal application.
3872	PHYLLOSTACHYS NIGRA	A, E, H
3873	PHYSALIS ALKEKENGI	A, H
3874	PHYSALIS PUBESCENS	A, H
3875	PHYTANTRIOL	E	Only for use in topical medicines for dermal application. The concentration in the medicine must be no more than 0.5%.
3876	PHYTOL	E	Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.
3877	PHYTOLACCA AMERICANA	A, H	The maximum recommended daily dose of the medicine must contain no more than 1mg of the equivalent dry herb.
3878	PHYTOMENADIONE	A, E
3879	PHYTOSPHINGOSINE	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.1%.
3880	PHYTOSTERYL/OCTYLDODECYL LAUROYL GLUTAMATE	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.1%.
3881	PICEA ABIES	A, H
3882	PICEA MARIANA	A, H
3883	PICRASMA EXCELSA	A, E, H
3884	PICRORRHIZA KURROA	A, E, H
3885	PIGMENT BLUE 15	E	Permitted for use only as a colour for topical and dental use. The concentration in medicine must be no more than 0.003%.
3886	PIGMENT BLUE 15:1	E	Permitted for use only as a colour for topical use. Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.21%.
3887	PIGMENT GREEN 7	E	Permitted for use only as a colour for topical and dental use. When for dental use, the concentration in the medicine must be no more than 0.003%. When for topical use, the concentration in the medicine must be no more than 0.17%.
3888	PIGMENT RED 4	E	Permitted for use only as a colour for topical use.
3889	PIGMENT RED 53	E	Permitted for use only as a colour for topical use.
3890	PIGMENT RED 57	E	Permitted for use only as a colour for topical use.
3891	PIGMENT RED 57 ALUMINIUM LAKE	E	Permitted for use only as a colour for topical use.
3892	PIGMENT RED 57 BARIUM LAKE	E	Permitted for excipient use as a colour in topical medicines for dermal application. Not to be included in medicines intended for use in the eye.
3893	PIGMENT RED 63	E	Permitted for use only as a colour for topical use.
3894	PIGMENT WHITE 26	E	Permitted for use only as a colour for topical use.
3895	PIGMENT YELLOW 12	E	Permitted for use only as a colour for topical use.
3896	PILOCARPUS JABORANDI	A, H	Pilocarpine is a mandatory component of Pilocarpus jaborandi. The concentration of pilocarpine in the medicine must be no more than 0.025%.
3897	PILOCARPUS MICROPHYLLUS	A, H	Pilocarpine is a mandatory component of Pilocarpus microphyllus. The concentration of pilocarpine in the medicine must be no more than 0.025%.
3898	PILOCARPUS PINNATIFOLIUS	A, H	Pilocarpine is a mandatory component of Pilocarpus pinnatifolius. The concentration of pilocarpine in the medicine must be no more than 0.025%.
3899	PIMENTA FRUIT OIL	A, E, H
3900	PIMENTA LEAF OIL	A, E, H
3901	PIMENTA OFFICINALIS	A, E, H
3902	PIMENTA RACEMOSA	A, E, H	When the plant preparation for Pimenta racemosa is an oil and the concentration of this oil in the medicine is more than 25%, the nominal capacity of the container must be no more than 25 mL. When the plant preparation for Pimenta racemosa is an oil, the concentration of this oil in the medicine is more than 25%, and the nominal capacity of the container is more than 15 mL, a restricted flow insert must be fitted on the container. When the plant preparation for Pimenta racemosa is an oil, the concentration of this oil in the medicine is more than 25%, and the nominal capacity of the container is more than 15 mL but no more than 25 mL, a child resistant closure and restricted flow insert must be fitted on the container. The medicine requires the following warning statements on the medicine label: - (CHILD) 'Keep out of reach of children' (or word to that effect) - (NTAKEN) 'Not to be taken'.
3903	PIMPINELLA ANISUM	A, E, H	When the plant preparation for Pimpinella anisum is an oil or distillate and the concentration of this oil or distillate in the medicine is more than 50%: a) the nominal capacity of the container must not be more than 50 millilitres; and b) a restricted flow insert must be fitted on the container; and c) the medicine requires the following warning statement on the medicine label: - (CHILD) ‘Keep out of reach of children’ (or words to that effect).
3904	PIMPINELLA SAXIFRAGA	A, E, H
3905	PINE NEEDLE OIL SCOTCH	A, E, H
3906	PINE NEEDLE OIL TERPENELESS	E	Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.
3907	PINE OIL AROMATIC	A, E, H
3908	PINE OIL PUMILIO	A, E, H
3909	PINEAPPLE	E
3910	PINEAPPLE OILS	E	Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.
3911	PINELLIA TERNATA	A, H
3912	PINUS CONTORTA	A, E, H
3913	PINUS ELLIOTTII	E	Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5% If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.
3914	PINUS MASSONIANA	A, E, H	When the plant preparation is oil or distillate the total concentration of Pinus massoniana oil or distillate in the preparation must be no more than 25%.
3915	PINUS MONTICOLA	A, E, H
3916	PINUS MUGO	A, E, H
3917	PINUS PALUSTRIS	E	Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.
3918	PINUS PINASTER	A, E, H	When the plant preparation is oil or distillate the total concentration of Pinus pinaster oil or distillate in the preparation must be no more than 25%.
3919	PINUS PONDEROSA	A, E, H
3920	PINUS RADIATA	A, E, H
3921	PINUS STROBUS	A, E, H
3922	PINUS SYLVESTRIS	A, E, H
3923	PINUS TABULIFORMIS	A, E, H
3924	PINUS YUNNANENSIS	E	Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.
3925	PIPENZOLATE BROMIDE	E	Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
3926	PIPER CHABA	A, E, H
3927	PIPER CUBEBA	A, E, H
3928	PIPER KADSURA	A, E, H
3929	PIPER LONGUM	A, E, H
3930	PIPER METHYSTICUM	A, H	Kavalactones (of Piper methysticum) is a mandatory component of Piper methysticum. Only for oral use when the dosage form is 'tablet' or 'capsule'; or when the container type is 'tea bag'. When used in oral medicines, the maximum daily dose of kavalactones (of Piper methysticum) must be no more than 250 mg. If the dosage form is tablet or capsule then the quantity of kavalactones (of Piper methysticum) must be no more than 125 mg per tablet or capsule. Oral medicines containing more than 25 mg of kavalactones (of Piper methysticum) per dose require the following warning statement on the medicine label: - (PIPER) 'Not for prolonged use. If symptoms persist - seek advice from a healthcare practitioner. Not recommended for pregnant or lactating women (or words to that effect). May harm the liver'. The plant part must be root or rhizome. When for oral use, the medicine may only contain dried whole or peeled root or rhizome or aqueous dispersions or aqueous extracts of whole or peeled root or rhizome. When for topical use on the rectum, vagina or throat, the medicine may only contain dried whole or peeled root or rhizome or aqueous dispersions or aqueous extracts of whole or peeled root or rhizome. When the container type is tea bag the maximum quantity per tea bag must be no more than 3 grams of dried whole or peeled root or rhizomes.
3931	PIPER NIGRUM	A, E, H
3932	PIPER SARMENTOSUM	A, E, H
3933	PIPERINE	E	Permitted for use only in combination with other permitted ingredients as a flavour proprietary formulation. The total flavour proprietary formulation in a medicine must not be more than 5% and the concentration of piperine in the medicine must not be more than 0.15%.
3934	PIPERITONE	E	Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
3935	PIPERONAL	E	Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.
3936	PIPERONYL ACETONE	E	Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used as a flavour the total flavour concentration in a medicine must be no more than 5%. If used as in a fragrance the total fragrance concentration in a medicine must be no more than 1%.
3937	PIPERONYL BUTOXIDE	E	Only for use in topical medicines for dermal application.
3938	PIROCTONE OLAMINE	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 1% in wash-on/wash-off medicines and 0.5% in leave-on medicines.
3939	PISCIDIA PISCIPULA	A, E, H
3940	PISTACIA LENTISCUS	A, E, H
3941	PISUM SATIVUM	A, E, H
3942	PLACENTA	H	Only for use as an active homoeopathic ingredient.
3943	PLANTAGO AFRA	A, E, H	When a dose for children is stated and the plant part is flower, seed or pollen, the following warning statement is required on the label: - (PSYLL1) 'Should only be used for children on medical advice' (or words to that effect).
3944	PLANTAGO ARENARIA	A, H	When a dose for children is stated and the plant part is flower, seed or pollen, the following warning statement is required on the label: - (PSYLL1) 'Should only be used for children on medical advice' (or words to that effect).
3945	PLANTAGO ASIATICA	A, H	When a dose for children is stated and the plant part is flower, seed or pollen, the following warning statement is required on the label: - (PSYLL1) 'Should only be used for children on medical advice' (or words to that effect).
3946	PLANTAGO LANCEOLATA	A, E, H	The medicine requires the following warning statement on the medicine label: - (CHILD5) 'Use in children under 3 years is not recommended’ When a dose for children is stated and the plant part is flower, seed or pollen, the following warning statement is required on the label: - (PSYLL1) 'Should only be used for children on medical advice' (or words to that effect).
3947	PLANTAGO MAJOR	A, E, H	When a dose for children is stated and the plant part is flower, seed or pollen, the following warning statement is required on the label: - (PSYLL1) 'Should only be used for children on medical advice' (or words to that effect).
3948	PLANTAGO OVATA	A, H	When a dose for children is stated and the plant part is flower, seed or pollen, the following warning statement is required on the label: - (PSYLL1) 'Should only be used for children on medical advice' (or words to that effect).
3949	PLANTAGO SEED DRY	A, H	When a dose for children is stated and the plant part is flower, seed or pollen, the following warning statement is required on the label: - (PSYLL1) 'Should only be used for children on medical advice' (or words to that effect).
3950	PLATANUS OCCIDENTALIS	A, E, H
3951	PLATANUS RACEMOSA	A, H
3952	PLATANUS × HISPANICA	A, H
3953	PLATYCODON GRANDIFLORUS	A, E, H
3954	PLECTRANTHUS BARBATUS	A, E, H
3955	PLICATONE	E	Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.
3956	PLUM	E
3957	PLUMBAGO EUROPAEA	A, H
3958	PLUMERIA ALBA	A, E, H
3959	PLUMERIA RUBRA	A, E, H
3960	POA NEMORALIS	A, H
3961	POA PRATENSIS	A, H
3962	PODOPHYLLUM PELTATUM	A, H	Podophyllin and podophyllotoxin are mandatory components of Podophyllum peltatum. The concentration of podophyllin in the medicine must be no more than 1 mg/kg or 1 mg/L or 0.0001%. The concentration of podophyllotoxin in the medicine must be no more than 10 mg/kg or 10 mg/L or 0.001%.
3963	POGOSTEMON CABLIN	A, E, H
3964	POLACRILIN	E
3965	POLACRILIN POTASSIUM	E
3966	POLAPREZINC	A	Only for use in oral medicines. Zinc is a mandatory component of Polaprezinc. The maximum recommended daily dose must be no more than 34 milligrams of zinc sourced from polaprezinc. When for internal use, the maximum recommended daily dose must be no more than 50mg of zinc. When for internal use and the maximum recommended daily dose is more than 25mg but no more than 50mg of zinc, the medicine requires the following warning statement on the medicine label: - (ZINC) 'WARNING: May be dangerous if taken in large amounts or for a long period.' OR 'WARNING: Contains zinc which may be dangerous if taken in large amounts or for a long period' (or words to that effect).
3967	POLIGLUSAM	A, E	The average molecular mass of poliglusam must be greater than 2 kilodaltons. When for internal use: (a) the maximum recommended daily dose of the medicine must not provide more than 1750 milligrams poliglusam; and (b) the following warning statement is required on the medicine label: - (CHITO) 'Poliglusam should be taken at least one hour after any other medication as it may reduce the effect of other medication' (or words to that effect). When for internal use and the dosage form is a powdered preparation, the following warning statement is required on the medicine label: - (DNTPOW) 'Do not take powder alone. Mix with food or fluid'. When used as an excipient, only for use in topical medicines for dermal application.
3968	POLIGLUSAM DERIVED FROM ASPERGILLUS NIGER	A, E	When for oral use: (a) the maximum recommended daily dose of the medicine must not provide more than 2000 mg of Poliglusam derived from Aspergillus niger; (b) the following warning statement (or words to the same effect) is required on the medicine label: - (CHITO) 'Poliglusam should be taken at least one hour after any other medication as it may reduce the effect of other medication.'; and (c) if the medicine is a powdered dosage form, the following warning statement is also required on the medicine label: - (DNTPOW) 'Do not take powder alone. Mix with food or fluid.' When used as an excipient, Poliglusam derived from Aspergillus niger is only permitted for use in topical medicines for dermal application.
3969	POLLACK-LIVER OIL	A, E	Colecalciferol and Vitamin A are mandatory components of Pollack-liver oil. When for use in topical medicines, the concentration of Vitamin A in the medicine must be no more than 1%. When for internal use, the maximum daily dose must be no more than 3000 micrograms of Retinol Equivalents. When preparations for internal use in adults contain more than 33 micrograms of retinol equivalents per dosage unit in divided preparations or per gram of an undivided preparation, the medicine requires the following warning statements on the medicine label: - (VITA2) ‘WARNING: If you are pregnant - or considering becoming pregnant - do not take vitamin A supplements without consulting your doctor or pharmacist [or words to that effect].’ NOTE: Position this warning at the beginning of the directions for use. - (VITA4) ‘WARNING - When taken in excess of 3000 micrograms retinol equivalents - Vitamin A can cause birth defects.’ NOTE: Position this warning at the beginning of the directions for use. - (VITA3) ‘The recommended daily amount of Vitamin A from all sources is 700 micrograms retinol equivalents for women and 900 micrograms retinol equivalents for men.’ When for internal use, the maximum recommended daily dose must be no more than 25 micrograms of Vitamin D.
3970	POLLEN	E	The medicine requires the following warning statement on the medicine label: - (POLLEN) 'This medicine can cause severe allergic reactions' (or words to that effect).
3971	POLOXAMER	E	Only for use in topical medicines for dermal application.
3972	POLOXAMINE	E	Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.
3973	POLY C10-30 ALKYL ACRYLATE	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 2%.
3974	POLYACRYLAMIDE	E	Only for use in topical medicines for dermal application. Acrylamide is a mandatory component of Polyacrylamide. The concentration of Acrylamide in the medicine must be no more than 0.01%.
3975	POLYACRYLATE CROSSPOLYMER-6	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye or on damaged skin. The concentration in the medicine must be no more than 2%.
3976	POLYACRYLATE DISPERSION (30 PER CENT)	E	Methyl methacrylate is a mandatory component of polyacrylate dispersion (30 per cent). The total concentration of methyl methacrylate as residual monomer in the medicine must not be more than 1%. The route of administration for medicines that contain polyacrylate dispersion (30 per cent) must be limited to oral use. Polyacrylate dispersion (30 per cent) is not permitted for use in children under the age of 4 years. The maximum recommended daily dose of the medicine must not provide more than: a) 1.33 grams of polyacrylate dispersion (30 per cent) to individuals aged 4 to 17 years (inclusive); and b) 4.67 grams of polyacrylate dispersion (30 per cent) to individuals aged 18 years and above.
3977	POLYACRYLATE-1 CROSSPOLYMER	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye or on damaged skin. The concentration in the medicine must be no more than 0.4%.
3978	POLYACRYLIC ACID	E
3979	POLYAMINO SUGAR CONDENSATE	E	Only for use in topical medicines for dermal application.
3980	POLYAMINOPROPYL BIGUANIDE	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.3%.
3981	POLYBUTADIENE	E	Only for use as part of an adhesive in topical medicines for dermal application.
3982	POLYBUTENE	E	Only for use in topical medicines for dermal application.
3983	POLYBUTYLENE GLYCOL/PPG-9/1 COPOLYMER	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 2%.
3984	POLYCAPROLACTONE	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.1%.
3985	POLYDECENE	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 6%.
3986	POLYDEXTROSE	E
3987	POLYDIETHYLSILOXANE	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye or on damaged skin. The concentration in the medicine must be no more than 5%.
3988	POLYDIMETHYL SILOXANE	E	Permitted for use only in combination with other permitted ingredients as a printing ink. If used in a printing ink the total printing ink concentration in a medicine must be no more than 0.1%
3989	POLYESTER-10	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 1.5%.
3990	POLYESTER-25	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye or on damaged skin. The concentration in the medicine must be no more than 10%.
3991	POLYESTER-7	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 5%.
3992	POLYESTER-8	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration of Polyester-8 must be no more than 5%.
3993	POLYETHYLENE	E
3994	POLYGALA CHINENSIS	A, H
3995	POLYGALA SENEGA	A, E, H	Except when used in a medicine containing only homoeopathic preparations, a child resistant closure and restricted flow insert must be fitted onto the container.
3996	POLYGALA SIBIRICA	A, E, H	Only for use when the plant part is root or root bark.
3997	POLYGALA TENUIFOLIA	A	Only for use when the plant part is root or root bark.
3998	POLYGLYCERYL-10 PENTASTEARATE	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 1.5%.
3999	POLYGLYCERYL-2 CAPRATE	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use on damaged skin or in the eye. The concentration in the medicine must not be more than 0.5%.
4000	POLYGLYCERYL-2 DIISOSTEARATE	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 3.0%.
4001	POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE	E	Only for use in topical medicines for dermal application. The concentration in the medicine must be no more than 5%.
4002	POLYGLYCERYL-2 DISTEARATE	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must not be more than 3%.
4003	POLYGLYCERYL-2 ISOSTEARATE	E	Polyglyceryl-2 isostearate must: (a) Only be used in topical medicines for dermal application; and (b) Not be included in medicines intended for use on broken skin or in the eye. The concentration in the medicine must be no more than 2.5%.
4004	POLYGLYCERYL-2 TRIISOSTEARATE	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. When the concentration of polyglyceryl-2 triisostearate is greater than 3%, the medicine must not be intended for use on damaged skin. The concentration in the medicine must not be more than 5%.
4005	POLYGLYCERYL-2-PEG-4 STEARATE	E	Only for use in topical medicines for dermal application.
4006	POLYGLYCERYL-3 BEESWAX	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye or on damaged skin. The concentration in the medicine must be no more than 0.5%.
4007	POLYGLYCERYL-3 DIISOSTEARATE	E	Only for use in topical medicines for dermal application.
4008	POLYGLYCERYL-3 DISTEARATE	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.5%.
4009	POLYGLYCERYL-3 METHYLGLUCOSE DISTEARATE	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 6%.
4010	POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 5.5%.
4011	POLYGLYCERYL-3 POLYRICINOLEATE	E
4012	POLYGLYCERYL-3 STEARATE/ISOSTEARATE/DIMER DILINOLEATE CROSSPOLYMER	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye or on damaged skin. The concentration in the medicine must be no more than 5%.
4013	POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 3%.
4014	POLYGLYCERYL-4 ISOSTEARATE	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 5%.
4015	POLYGLYCERYL-4 OLEATE	E	Only for use in topical medicines for dermal application.
4016	POLYGLYCERYL-6 POLYRICINOLEATE	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 1%.
4017	POLYGLYCERYL-6 RICINOLEATE	E	Only for use in topical medicines for dermal application.
4018	POLYGONATUM MULTIFLORUM	A, H
4019	POLYGONATUM OFFICINALE	A, H
4020	POLYGONATUM SIBIRICUM	A, E, H
4021	POLYGONUM AVICULARE	A, E, H	When used as an excipient, the medicine is only for use in topical medicines for dermal application and not to be included in medicines intended for use on damaged skin or in the eye. When used as an excipient, the concentration in the medicine must be no more than 0.16%.
4022	POLYGONUM BISTORTA	A, H
4023	POLYGONUM ODORATUM	A, H
4024	POLYHYDROXYSTEARIC ACID	E	Only for use in topical medicines for dermal application.
4025	POLYISOBUTYLENE	E	Only for use when the dosage form is 'chewing gum'. Must comply with: a) the Polyisobutylene monograph in the Food Chemicals Codex published by the United States Pharmacopeial Convention, as in force or existing from time to time; and b) the requirements for residual solvents and catalysts in the British Pharmacopoeia or the United States Pharmacopeia National Formulary, as in force or existing from time to time.
4026	POLYISOPRENE	E	Only for use in topical medicines for dermal application.
4027	POLYLIMONENE	E	Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
4028	POLYMETHACRYLIC ACID	E
4029	POLYMETHYL METHACRYLATE	E	Methyl methacrylate is a mandatory component of polymethyl methacrylate. Only for use in topical medicines for dermal application. The total concentration of methyl methacrylate as residual monomer in the medicine must not be more than 1%.
4030	POLYMETHYLSILSESQUIOXANE	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 3%.
4031	POLYPORUS UMBELLATUS	A, H
4032	POLYPROPYLENE	E	Only for use in topical medicines for dermal application.
4033	POLYPROPYLENE GLYCOL	E	Permitted for use only in combination with other permitted ingredients as part of a flavour or fragrance proprietary excipient formulation. When used in a flavour, the total flavour proprietary excipient formulation in a medicine must be no more than 5%. When used in a fragrance, the total fragrance proprietary excipient formulation in a medicine must be no more than 1%.
4034	POLYQUATERNIUM-10	E	Only for use in topical medicines for dermal application.
4035	POLYQUATERNIUM-11	E	Only for use in topical medicines for dermal application.
4036	POLYQUATERNIUM-22	E	Only for use in wash-off topical medicines for dermal application and not to be included in medicines intended for use in the eye or on damaged skin. The concentration in the medicine must be no more than 2%.
4037	POLYQUATERNIUM-24	E	Only for use in topical medicines for dermal application.
4038	POLYQUATERNIUM-28	E	Only for use in topical medicines for dermal application.
4039	POLYQUATERNIUM-37	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 2.5%.
4040	POLYQUATERNIUM-4	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must not be more than 0.4%.
4041	POLYQUATERNIUM-44	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.3%.
4042	POLYQUATERNIUM-51	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 5%.
4043	POLYQUATERNIUM-7	E	Only for use in topical medicines for dermal application.
4044	POLYSILICONE-11	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 2.1%
4045	POLYSILICONE-14	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration of Polysilicone-14 must be no more than 1%.
4046	POLYSILICONE-15	A	Only for use as an active ingredient in sunscreens for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must not be more than 10%. When used in primary sunscreen products, the following warning statements are required on the label: - (AVOID) 'Avoid prolonged exposure in the sun' (or words to this effect); and - (SUNPRO) 'Wear protective clothing - hats and eyewear when exposed to the sun' (or words to this effect).
4047	POLYSILICONE-2	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.13%.
4048	POLYSORBATE 20	E
4049	POLYSORBATE 40	E
4050	POLYSORBATE 60	E
4051	POLYSORBATE 65	E
4052	POLYSORBATE 80	E
4053	POLYSORBATE 85	E	Only for use in topical medicines for dermal application.
4054	POLYSTYRENE	E	Only for use as part of an adhesive in topical medicines for dermal application.
4055	POLYTEF	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.5%.
4056	POLYURETHANE-34	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye or on damaged skin. The concentration in the medicine must be no more than 2% in spray applications and 6% in non-spray applications.
4057	POLYURETHANE-62	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye or on damaged skin. The concentration in the medicine must be no more than 5%.
4058	POLYVINYL ACETATE	E	Only permitted for use in medicines that are for oral routes of administration.
4059	POLYVINYL ACETATE PHTHALATE	E
4060	POLYVINYL ALCOHOL	E
4061	POLYVINYL CHLORIDE	E	Only for use in topical medicines for dermal application.
4062	POMEGRANATE	E
4063	PONCEAU SX	E	Permitted for use only as a colour for topical use.
4064	PONCIRUS TRIFOLIATA	A, H	When used internally, oxedrine is a mandatory component of Poncirus trifoliata. The quantity of Oxedrine in the maximum recommended daily dose must be no more than 30 mg.
4065	PONGAMOL	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 1%.
4066	PONTEDERIA CRASSIPES	A, H
4067	POPPY SEED	E, H
4068	POPPY SEED OIL	E, H
4069	POPULUS ALBA	A, H
4070	POPULUS BALSAMIIFERA	A, E, H
4071	POPULUS CANDICANS	A, H
4072	POPULUS DELTOIDES	A, H
4073	POPULUS NIGRA	A, H
4074	POPULUS TREMULA	A, H
4075	POPULUS TREMULOIDES	A, H
4076	PORCINE	H	Only for use as an active homoeopathic ingredient.
4077	PORPHYRIDIUM PURPUREUM EXTRACT	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.5%.
4078	PORTULACA OLERACEA	A, E, H
4079	POTABLE WATER	E
4080	POTASSIUM ACETATE	E
4081	POTASSIUM ARSENITE	H	Only for use as an active homoeopathic ingredient.
4082	POTASSIUM ASCORBATE	A, E, H	When for oral or sublingual use, potassium is a mandatory component of potassium ascorbate.
4083	POTASSIUM ASCORBATE DIHYDRATE	A, E, H	When for oral or sublingual use, potassium is a mandatory component of potassium ascorbate dihydrate.
4084	POTASSIUM ASCORBYL TOCOPHERYL PHOSPHATE	E	Only for use in topical medicines for dermal application.
4085	POTASSIUM ASPARTATE	A, E, H	When used as an active ingredient and the medicine is intended as a mineral supplementation, potassium is a mandatory component of potassium aspartate.
4086	POTASSIUM ASPARTATE DIHYDRATE	A, E, H	If used as an active ingredient and the preparation is intended as a mineral supplementation, potassium is a mandatory component of Potassium aspartate dihydrate. The percentage of potassium from potassium aspartate dihydrate should be calculated based on the molecular weight of potassium aspartate dihydrate.
4087	POTASSIUM ASPARTATE MONOHYDRATE	A, E	If used as an active ingredient and the preparation is intended as a mineral supplementation, potassium is a mandatory component of Potassium aspartate monohydrate. The percentage of potassium from potassium aspartate monohydrate should be calculated based on the molecular weight of potassium aspartate monohydrate.
4088	POTASSIUM BICARBONATE	E
4089	POTASSIUM BROMIDE	H	Only for use as an active homoeopathic ingredient. The total concentration of potassium bromide in the medicine must not be more than 10 mg/kg or 10 mg/L or 0.001%.
4090	POTASSIUM CARBONATE	E, H	When used in a solid preparation, the pH of a 10 g/L aqueous solution must not be more than 11.5. When used in a liquid or a semi-solid preparation, the pH of the preparation must not exceed 11.5.
4091	POTASSIUM CETYL PHOSPHATE	E	Only for use in topical medicines for dermal application.
4092	POTASSIUM CHLORIDE	A, E, H	When for oral use: (a) potassium is a mandatory component of potassium chloride; (b) the medicine requires the following warning statement on the medicine label: - 'If you have kidney disease or are taking heart or blood pressure medicines - consult your doctor or pharmacist before use. Keep out of reach of children.'; and (c) except when the medicine is for use as oral rehydration therapy, the amount of potassium chloride per dosage unit must not be more than 550 mg. Medicines containing potassium chloride for use as oral rehydration therapy, are subject to the following conditions: (a) the medicine complies with the requirements specified in the British Pharmacopoeia, as in force or existing from time to time, for Oral Rehydration Salts; (b) the sodium, potassium and glucose content, and total osmolarity of the solution after it has been prepared according to the instructions on the packet are consistent with the criteria specified by the World Health Organisation (WHO) and the United Nations Children's Fund (UNICEF) in the document 'Expert consultation on oral rehydration salts formulation' 18 July 2001; and (c) the following warning statements are required on the medicine label: - (UOAD) 'Use only as directed' - (DIAR3) 'If diarrhoea persists, seek medical advice.' When for dental use, the concentration of potassium chloride in the medicine must not be more than 3.75%.
4093	POTASSIUM CITRATE	A, E, H	When used as an active ingredient and the medicine is intended as a mineral supplementation, potassium is a mandatory component of potassium citrate.
4094	POTASSIUM COCOYL HYDROLYSED COLLAGEN	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 10%.
4095	POTASSIUM COCOYL HYDROLYSED SOY PROTEIN	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.15%.
4096	POTASSIUM DICHROMATE	H	Only for use as an active homoeopathic ingredient.
4097	POTASSIUM GLUCONATE	A, E, H	When used as an active ingredient and the medicine is intended as a mineral supplementation, potassium is a mandatory component of potassium gluconate.
4098	POTASSIUM GLYCEROPHOSPHATE	A, E, H	When used as an active ingredient and the medicine is intended as a mineral supplementation, potassium is a mandatory component of potassium glycerophosphate.
4099	POTASSIUM HYDROXIDE	E	The concentration in the medicine must be no more than 5%. When used in a solid preparation, the pH of a 10 g/L aqueous solution must not be more than 11.5. When used in a liquid or a semi-solid preparation, the pH of the preparation must not exceed 11.5.
4100	POTASSIUM HYDROXYCITRATE	A, H	The requirements specified below apply to a medicine that contains the ingredient that is: - listed in the Register on or after 1 March 2025; or - released for supply on or after 1 March 2026. When for oral use, the following warning statement is required on the medicine label: - (PHLIVER) ‘In very rare cases, potassium hydroxycitrate may harm the liver. Stop use and see a doctor if you have yellowing skin/eyes or unusual: fatigue, nausea, appetite loss, abdominal pain, dark urine, or itching.’ Medicines containing potassium hydroxycitrate must not be directed for use in children, or in pregnant or lactating women.
4101	POTASSIUM IODATE	A, H	Iodine is a mandatory component of potassium iodate. The percentage of iodine from potassium iodate should be calculated based on the molecular weight of potassium iodate. When for use in adults, the medicine must contain a daily dose of no more than 505 micrograms of potassium iodate. When for use in children aged 1-3 years, the medicine must contain a daily dose of no more than 337 micrograms of potassium iodate.
4102	POTASSIUM IODIDE	A, E, H	Iodine is a mandatory component of potassium iodide. The percentage of iodine from potassium iodide should be calculated based on the molecular weight of potassium iodide. When for internal use, the maximum recommended daily dose of the medicine must contain less than 300 micrograms of iodine. When for external use, the concentration of iodine in the medicine (excluding salt derivatives or iodophors) must not exceed 2.5%.
4103	POTASSIUM METABISULFITE	E	Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
4104	POTASSIUM METAPHOSPHATE	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.5%.
4105	POTASSIUM NITRATE	A, H	Only for dental use. The concentration in the medicine must be no more than 5%.
4106	POTASSIUM OROTATE	A, E, H	When used as an active ingredient and the medicine is intended as a mineral supplementation, potassium is a mandatory component of potassium orotate. When used in a solid preparation, the pH of a 10 g/L aqueous solution must not be more than 11.5. When used in a liquid or a semi-solid preparation, the pH of the preparation must not exceed 11.5.
4107	POTASSIUM PYROPHOSPHATE	E	Only for oral application, dental or topical use. Not to be included in topical medicines intended for use in the eye. The concentration in the medicine must be no more than 3%.
4108	POTASSIUM SORBATE	E
4109	POTASSIUM STANNATE	E	Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.
4110	POTASSIUM STEARATE	E	Only for use in topical medicines for dermal application.
4111	POTASSIUM SULFATE	A, E, H	When used as an active ingredient and the medicine is intended as a mineral supplementation, potassium is a mandatory component of potassium sulfate. When used in a solid preparation, the pH of a 10 g/L aqueous solution must not be more than 11.5. When used in a liquid or a semi-solid preparation, the pH of the preparation must not exceed 11.5.
4112	POTATO STARCH	E
4113	POTENTILLA ANSERINA	A, H
4114	POTENTILLA CHINENSIS	A, H
4115	POTENTILLA DISCOLOR	A, H
4116	POTENTILLA ERECTA	A, E, H
4117	POTENTILLA REPTANS	A, H
4118	POTERIUM OFFICINALE	A, E, H
4119	POTERIUM SANGUISORBA	A, H
4120	POVIDONE	E
4121	POWDERED CELLULOSE	E
4122	PPG-1-PEG-9 LAURYL GLYCOL ETHER	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 5%.
4123	PPG-12/SMDI COPOLYMER	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 2%.
4124	PPG-15 STEARYL ETHER	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 4%.
4125	PPG-15 STEARYL ETHER BENZOATE	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 1.4%.
4126	PPG-17/IPDI/DMPA COPOLYMER	E	Only for use in topical medicines for dermal application and not to be included in topical medicines intended for use in the eye or on damaged skin. The concentration of PPG-17/IPDI/DMPA Copolymer in the medicine must be no more than 10%.
4127	PPG-2 LANOLIN ALCOHOL ETHER	E	Only for use in topical medicines for dermal application.
4128	PPG-2 MYRISTYL ETHER PROPIONATE	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 5%.
4129	PPG-20 LANOLIN ALCOHOL ETHER	E	Only for use in topical medicines for dermal application.
4130	PPG-20 METHYL GLUCOSE ETHER	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.5%.
4131	PPG-20 METHYL GLUCOSE ETHER DISTEARATE	E	Only for use in topical medicines for dermal application.
4132	PPG-3 HYDROGENATED CASTOR OIL	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 6%.
4133	PPG-3 MYRISTYL ETHER	E	Only for use in topical medicines for dermal application.
4134	PPG-5-CETETH-20	E	Only for use in topical medicines for dermal application.
4135	PPG-5-LAUROMACROGOL 250	E	Only for use in topical medicines for dermal application.
4136	PRALINE	E	Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
4137	PREGELATINISED MAIZE STARCH	E
4138	PREGELATINISED POTATO STARCH	E
4139	PREGELATINISED RICE STARCH	E
4140	PREGELATINISED STARCH	E
4141	PREGELATINISED WHEAT STARCH	E	When the route of administration is other than topical or mucosal, gluten is a mandatory component of pregelatinised wheat starch.
4142	PRENYL ACETATE	E	Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.
4143	PRICKLY ASH BARK DRY	A, H
4144	PRICKLY ASH BARK POWDER	A, H
4145	PRIMULA VERIS	A, E, H
4146	PRIMULA VULGARIS	A, E, H
4147	PRINSEPIA UNIFLORA	A, H
4148	PROBOSCIDEA PARVIFLORA	A, H
4149	PROGESTERONE	H	Only for use as an active homoeopathic ingredient. The total concentration of progesterone in the medicine must not be more than 1 mg/kg or 1 mg/L or 0.0001%.
4150	PROLINE	A, E
4151	PROPAN-1-OL	E	Only for use in: - topical medicines for dermal application; or - in combination with other permitted ingredients as a flavour proprietary excipient formulation. The concentration of propan-1-ol in the medicine must not be more than 18%. When used in medicines in combination with other permitted ingredients as a flavour proprietary excipient formulation, the total flavour proprietary excipient formulation in a medicine must not be more than 5%.
4152	PROPANE	E	Only for use as an excipient propellant ingredient.
4153	PROPANEDIOL	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye or on damaged skin. The concentration in the medicine must be no more than 10%.
4154	PROPENYL GUAETHOL	E	Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.
4155	PROPIONALDEHYDE	E	Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.
4156	PROPIONIC ACID	E	Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.
4157	PROPIONYLLEVOCARNITINE HYDROCHLORIDE	A, H
4158	PROPOLIS	A, E	Lead is a mandatory component of Propolis. The concentration of lead in the medicine must be no more than 0.001%. When used topically, the medicine requires the following warning statement on the medicine label: -(PROP1) 'WARNING: Propolis may cause skin irritation. Test before use' When used for other than for topical, the medicine requires the following warning statement on the medicine label: - (PROP2) 'Warning: Propolis may cause allergic reactions. If irritation or swelling of the mouth or throat occurs, discontinue use.'
4159	PROPOLIS BALSAM	A, E	Lead is a mandatory component of Propolis balsam. The concentration of lead in the medicine must be no more than 0.001%. When used topically, the medicine requires the following warning statement on the medicine label: -(PROP1) 'WARNING: Propolis may cause skin irritation. Test before use' When used for other than for topical, the medicine requires the following warning statement on the medicine label: - (PROP2) 'Warning: Propolis may cause allergic reactions. If irritation or swelling of the mouth or throat occurs, discontinue use.'
4160	PROPOLIS DRY EXTRACT	A, E	Lead is a mandatory component of Propolis dry extract. The concentration of lead in the medicine must be no more than 0.001%. When used topically, the medicine requires the following warning statement on the medicine label: -(PROP1) 'WARNING: Propolis may cause skin irritation. Test before use' When used for other than for topical, the medicine requires the following warning statement on the medicine label: - (PROP2) 'Warning: Propolis may cause allergic reactions. If irritation or swelling of the mouth or throat occurs, discontinue use.'
4161	PROPOLIS LIQUID EXTRACT	A, E	Lead is a mandatory component of Propolis liquid extract. The concentration of lead in the medicine must be no more than 0.001%. When used topically, the medicine requires the following warning statement on the medicine label: -(PROP1) 'WARNING: Propolis may cause skin irritation. Test before use' When used for other than for topical, the medicine requires the following warning statement on the medicine label: - (PROP2) 'Warning: Propolis may cause allergic reactions. If irritation or swelling of the mouth or throat occurs, discontinue use.'
4162	PROPOLIS RESIN	A, E	Lead is a mandatory component of propolis resin. The concentration of lead in the medicine must be no more than 0.001%. When used topically, the medicine requires the following warning statement on the medicine label: -(PROP1) 'WARNING: Propolis may cause skin irritation. Test before use' When used for other than for topical, the medicine requires the following warning statement on the medicine label: - (PROP2) 'Warning: Propolis may cause allergic reactions. If irritation or swelling of the mouth or throat occurs, discontinue use.'
4163	PROPOLIS TINCTURE	A, E	Lead is a mandatory component of Propolis tincture. The concentration of lead in the medicine must be no more than 0.001%. When used topically, the medicine requires the following warning statement on the medicine label: -(PROP1) 'WARNING: Propolis may cause skin irritation. Test before use' When used for other than for topical, the medicine requires the following warning statement on the medicine label: - (PROP2) 'Warning: Propolis may cause allergic reactions. If irritation or swelling of the mouth or throat occurs, discontinue use.'
4164	PROPYL ACETATE	E	Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
4165	PROPYL CAPROATE	E	Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
4166	PROPYL GALLATE	E
4167	PROPYL HYDROXYBENZOATE	E
4168	PROPYLENE CARBONATE	E	Only for use in topical medicines for dermal application.
4169	PROPYLENE GLYCOL	E
4170	PROPYLENE GLYCOL ALGINATE	E	Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
4171	PROPYLENE GLYCOL DIBENZOATE	E	Only for use in topical medicines for dermal application only and not to be used in topical medicines intended for use in the eye. The concentration in the medicine must be no more than 20%.
4172	PROPYLENE GLYCOL DIDECANOATE	E	Only for use in topical medicines for dermal application only and not to be used in topical medicines intended for use in the eye. The concentration in the medicine must be no more than 1%.
4173	PROPYLENE GLYCOL DIOCTANOATE	E	Only for use in topical medicines for dermal application.
4174	PROPYLENE GLYCOL DIOCTANOATE/DIDECANOATE	E	Only for use in topical medicines for dermal application.
4175	PROPYLENE GLYCOL DIPELARGONATE	E	Only for use in topical medicines for dermal application.
4176	PROPYLENE GLYCOL ISOCETETH-3 ACETATE	E	Only for use in topical medicines for dermal application only and not to be used in topical medicines intended for use in the eye. The concentration in the medicine must be no more than 1%.
4177	PROPYLENE GLYCOL ISOSTEARATE	E	Only for use in topical medicines for dermal application.
4178	PROPYLENE GLYCOL MONOLAURATE	E	Only for use in topical medicines for dermal application.
4179	PROPYLENE GLYCOL MONOSTEARATE	E	Only for use in topical medicines for dermal application.
4180	PROPYLENE GLYCOL MYRISTYL ETHER ACETATE	E	Only for use in topical medicines for dermal application.
4181	PROSOPIS JULIFLORA	A, H
4182	PROTEASE	A	Must be derived from Aspergillus oryzae or Aspergillus niger.
4183	PROTEIN HYDROLYSATE	E
4184	PRUNE JUICE	E	Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
4185	PRUNE JUICE CONCENTRATE	E	Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
4186	PRUNELLA VULGARIS	A, H
4187	PRUNUS AFRICANA	A, E, H	Amygdalin and hydrocyanic acid are mandatory components of Prunus africana. The concentration of amygdalin in the medicine must not be more than 10 mg/kg. The concentration of hydrocyanic acid in the medicine must not be more than 10 mg/kg.
4188	PRUNUS ARMENIACA	A, E, H	Amygdalin and hydrocyanic acid are mandatory components of Prunus armeniaca and must be declared in the application. The concentration of amygdalin in the medicine must not be more than 10 mg/kg. The concentration of hydrocyanic acid in the medicine must not be more than 10 mg/kg.
4189	PRUNUS AVIUM	A, E, H	Amygdalin and hydrocyanic acid are mandatory components of Prunus avium. The concentration of amygdalin in the medicine must not be more than 10 mg/kg. The concentration of hydrocyanic acid in the medicine must not be more than 10 mg/kg.
4190	PRUNUS CERASIFERA	A, E, H	Amygdalin and hydrocyanic acid are mandatory components of Prunus cerasifera. The concentration of amygdalin in the medicine must not be more than 10 mg/kg. The concentration of hydrocyanic acid in the medicine must not be more than 10 mg/kg.
4191	PRUNUS CERASUS	A, E, H	Amygdalin and hydrocyanic acid are mandatory components of Prunus cerasus. The concentration of amygdalin in the medicine must not be more than 10 mg/kg. The concentration of hydrocyanic acid in the medicine must not be more than 10 mg/kg.
4192	PRUNUS DOMESTICA	A, E, H	Amygdalin and hydrocyanic acid are mandatory components of Prunus domestica. The concentration of amygdalin in the medicine must not be more than 10 mg/kg. The concentration of hydrocyanic acid in the medicine must not be more than 10 mg/kg.
4193	PRUNUS DULCIS	A, E, H	Amygdalin and hydrocyanic acid are mandatory components of Prunus dulcis when the plant part is seed. When the plant part is seed, the maximum recommended daily dose must be no more than the equivalent of 1mg of the dry seed. The concentration of amygdalin in the medicine must not be more than 10 mg/kg. The concentration of hydrocyanic acid in the medicine must not be more than 10 mg/kg.
4194	PRUNUS HUMILIS	A, E, H	Amygdalin and hydrocyanic acid are mandatory components of Prunus humilis. The concentration of amygdalin in the medicine must not be more than 10 mg/kg. The concentration of hydrocyanic acid in the medicine must not be more than 10 mg/kg.
4195	PRUNUS JAPONICA	A, E, H	Amygdalin and hydrocyanic acid are mandatory components of Prunus japonica. The concentration of amygdalin in the medicine must not be more than 10 mg/kg. The concentration of hydrocyanic acid in the medicine must not be more than 10 mg/kg.
4196	PRUNUS LAUROCERASUS	A, E, H	Amygdalin and hydrocyanic acid are mandatory components of Prunus laurocerasus. The concentration of amygdalin in the medicine must not be more than 10 mg/kg. The concentration of hydrocyanic acid in the medicine must not be more than 10 mg/kg.
4197	PRUNUS MUME	A, E, H	Amygdalin and hydrocyanic acid are mandatory components of Prunus mume. The concentration of amygdalin in the medicine must not be more than 10 mg/kg. The concentration of hydrocyanic acid in the medicine must not be more than 10 mg/kg.
4198	PRUNUS PERSICA	A, E, H	Amygdalin and hydrocyanic acid are mandatory components of Prunus persica. The concentration of amygdalin in the medicine must not be more than 10 mg/kg. The concentration of hydrocyanic acid in the medicine must not be more than 10 mg/kg.
4199	PRUNUS SALICINA	A, E, H	Amygdalin and hydrocyanic acid are mandatory components of Prunus salicina. The concentration of amygdalin in the medicine must not be more than 10 mg/kg. The concentration of hydrocyanic acid in the medicine must not be more than 10 mg/kg.
4200	PRUNUS SEROTINA	A, E, H	Amygdalin and hydrocyanic acid are mandatory components of Prunus serotina. The concentration of amygdalin in the medicine must not be more than 10 mg/kg. The concentration of hydrocyanic acid in the medicine must not be more than 10 mg/kg.
4201	PRUNUS SPINOSA	A, E, H	Amygdalin and hydrocyanic acid are mandatory components of Prunus spinosa. The concentration of amygdalin in the medicine must not be more than 10 mg/kg. The concentration of hydrocyanic acid in the medicine must not be more than 10 mg/kg.
4202	PRUSSIAN BLUE	E	Permitted for use only as a colour for topical use.
4203	PSEUDOCYDONIA SINENSIS	A, H
4204	PSEUDOSTELLARIA HETEROPHYLLA	A, E, H
4205	PSEUDOTSUGA MENZIESII	A, H
4206	PSEUDOWINTERA COLORATA	A, H	Only for use when the plant part is leaf.
4207	PSIDIUM GUAJAVA	A, E, H
4208	PSORINUM	H	Only for use as an active homoeopathic ingredient.
4209	PSYLLIUM HUSK DRY	A, H	When a dose for children is stated, the following warning statement is required on the label: - (PSYLL1) 'Should only be used for children on medical advice' (or words to that effect).
4210	PSYLLIUM HUSK POWDER	A, E, H	When a dose for children is stated, the following warning statement is required on the label: - (PSYLL1) 'Should only be used for children on medical advice' (or words to that effect).
4211	PSYLLIUM SEED DRY	A, E, H	When a dose for children is stated the following warning statement is required on the label: - (PSYLL1) 'Should only be used for children on medical advice' (or words to that effect).
4212	PTELEA TRIFOLIATA	A, H
4213	PTEROCARPUS MARSUPIUM	A, H
4214	PTEROCARPUS SANTALINUS	A, E, H
4215	PUERARIA LOBATA	A, E, H
4216	PUERARIA MONTANA VAR. LOBATA	A, E, H
4217	PULLULAN	E
4218	PUMICE	E
4219	PUMPKIN	E
4220	PUMPKIN SEED OIL	E, H
4221	PUNICA GRANATUM	A, E, H
4222	PURE BEE VENOM	H	Only for use as an active homoeopathic ingredient.
4223	PURIFIED HONEY	A, E	When the route of administration is oral, the following warning statement is required on the medicine label: - (BABY2) 'Not suitable for infants under the age of twelve months' (or words to that effect).
4224	PURIFIED SILICEOUS EARTH	E, H
4225	PURIFIED TALC	E
4226	PURIFIED WATER	E
4227	PVM/MA COPOLYMER	E
4228	PVM/MA DECADIENE CROSSPOLYMER	E	Only for use in topical medicines for dermal application.
4229	PVP/EICOSENE COPOLYMER	E	Only for use in topical medicines for dermal application.
4230	PVP/HEXADECENE COPOLYMER	E	Only for use in topical medicines for dermal application.
4231	PYRETHRINS	E	Only for use in topical medicines for dermal application. The concentration in the medicine must be no more than 10%. The medicine requires the following warning statement on the medicine label: - (PYRTH3) 'Contains pyrethrins [insert quantity]' (or words to that effect).
4232	PYRIDOXAL 5-PHOSPHATE	A, E	Pyridoxine is a mandatory component of pyridoxal 5-phosphate. The percentage of pyridoxine from pyridoxal 5-phosphate should be calculated based on the molecular weight of pyridoxal 5-phosphate. The maximum recommended daily dose of the medicine must not provide more than: (i) 15 mg of pyridoxine for children aged between 1 and 3 years (inclusive); (ii) 20 mg of pyridoxine for children aged between 4 and 8 years (inclusive); (iii) 30 mg of pyridoxine for children aged between 9 and 13 years (inclusive); (iv) 40 mg of pyridoxine for individuals aged 14 and 18 years (inclusive); and (v) 100 mg of pyridoxine for individuals aged 19 years and older. If the maximum recommended daily dose of the medicine provides more than 10 mg of pyridoxine, the following warning statement is required on the medicine label: - (VITB6SX) 'WARNING - Stop taking this medication if you experience tingling, burning or numbness and see your healthcare practitioner as soon as possible. [Contains vitamin B6].
4233	PYRIDOXAL 5-PHOSPHATE MONOHYDRATE	A	Pyridoxine is a mandatory component of pyridoxal 5-phosphate monohydrate. The percentage of pyridoxine from pyridoxal 5-phosphate monohydrate should be calculated based on the molecular weight of pyridoxal 5-phosphate monohydrate. The maximum recommended daily dose of the medicine must not provide more than: (i) 15 mg of pyridoxine for children aged between 1 and 3 years (inclusive); (ii) 20 mg of pyridoxine for children aged between 4 and 8 years (inclusive); (iii) 30 mg of pyridoxine for children aged between 9 and 13 years (inclusive); (iv) 40 mg of pyridoxine for individuals aged 14 and 18 years (inclusive); and (v) 100 mg of pyridoxine for individuals aged 19 years and older. If the maximum recommended daily dose of the medicine provides more than 10 mg of pyridoxine, the following warning statement is required on the medicine label: - (VITB6SX) 'WARNING - Stop taking this medication if you experience tingling, burning or numbness and see your healthcare practitioner as soon as possible. [Contains vitamin B6].'
4234	PYRIDOXINE HYDROCHLORIDE	A, E, H	When not used as an active homoeopathic ingredient, pyridoxine is a mandatory component of pyridoxine hydrochloride. The percentage of pyridoxine from pyridoxine hydrochloride should be calculated based on the molecular weight of pyridoxine hydrochloride. The maximum recommended daily dose of the medicine must not provide more than: (i) 15 mg of pyridoxine for children aged between 1 and 3 years (inclusive); (ii) 20 mg of pyridoxine for children aged between 4 and 8 years (inclusive); (iii) 30 mg of pyridoxine for children aged between 9 and 13 years (inclusive); (iv) 40 mg of pyridoxine for individuals aged 14 and 18 years (inclusive); and (v) 100 mg of pyridoxine for individuals aged 19 years and older. If the maximum recommended daily dose of the medicine provides more than 10 mg of pyridoxine, the following warning statement is required on the medicine label: - (VITB6SX) 'WARNING - Stop taking this medication if you experience tingling, burning or numbness and see your healthcare practitioner as soon as possible. [Contains vitamin B6].'
4235	PYROGLUTAMIC ACID	E
4236	PYROLA DECORATA	A, H
4237	PYROLIGNEOUS ACID	E	Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
4238	PYRROSIA LINGUA	A, H
4239	PYRROSIA PETIOLOSA	A, H
4240	PYRROSIA SHEARERI	A, H
4241	PYRUS COMMUNIS	A, E, H	Beta-arbutin is a mandatory component of Pyrus communis. When for oral use, the maximum recommended daily dose must not provide more than 500 mg of beta-arbutin. When for dermal application exclusively to the face: a) the concentration of beta-arbutin in the medicine must not be more than 7%; b) hydroquinone is a mandatory component; and c) the concentration of hydroquinone must not be more than 10 mg/kg or 10 mg/L or 0.001%. When for use other than oral or dermal application exclusively to the face, the concentration of beta-arbutin in the medicine must not be more than 10 mg/kg or 10 mg/L or 0.001%.
4242	PYRUS PYRIFOLIA	A, H	Beta-arbutin is a mandatory component of Pyrus pyrifolia. When for oral use, the maximum recommended daily dose must not provide more than 500 mg of beta-arbutin. When for dermal application exclusively to the face: a) the concentration of beta-arbutin in the medicine must not be more than 7%; b) hydroquinone is a mandatory component; and c) the concentration of hydroquinone must not be more than 10 mg/kg or 10 mg/L or 0.001%. When for use other than oral or dermal application exclusively to the face, the concentration of beta-arbutin in the medicine must not be more than 10 mg/kg or 10 mg/L or 0.001%.
4243	PYRUVIC ACID	E	Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
4244	QUASSIA	E	Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
4245	QUASSIA AMARA	A, E, H
4246	QUASSIA WOOD JAMAICAN DRY	A, H
4247	QUASSIA WOOD JAMAICAN POWDER	A, H
4248	QUATERNIUM-15	E	Only for use in topical medicines for dermal application.
4249	QUATERNIUM-18 BENTONITE	E	Only for use in topical medicines for dermal application.
4250	QUATERNIUM-18 HECTORITE	E	Only for use in topical medicines for dermal application.
4251	QUATERNIUM-52	E	Only for use in wash-on/wash-off topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 1%. Not be used in medicines in which N-nitroso compounds may be formed.
4252	QUATERNIUM-80	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 2.5%.
4253	QUERCETIN	A
4254	QUERCETIN DIHYDRATE	A
4255	QUERCUS ACUTISSIMA	A, H
4256	QUERCUS ALBA	A, E, H
4257	QUERCUS PALUSTRIS	A, H
4258	QUERCUS ROBUR	A, H
4259	QUERCUS RUBRA	A, H
4260	QUERCUS VIRGINIANA	A, H
4261	QUILLAIA DRY	A, H
4262	QUILLAIA POWDER	A, E, H
4263	QUILLAJA SAPONARIA	A, H
4264	QUINCE	E
4265	QUININE ARSENITE	H	Only for use as an active homoeopathic ingredient. Quinine is a mandatory component of Quinine arsenite. The maximum recommended daily dose must be no more than 50 mg of quinine.
4266	QUININE SULFATE DIHYDRATE	H	Only for use as an active homoeopathic ingredient. Quinine is a mandatory component of quinine sulfate dihydrate. The maximum recommended daily dose must be no more than 50 mg of quinine.
4267	QUINOLINE YELLOW	E	Permitted for use only as a colour for oral and topical use.
4268	QUINOLINE YELLOW ALUMINIUM LAKE	E	Permitted for use only as a colour for oral and topical use.
4269	QUISQUALIS INDICA	A, H
4270	R-ALPHA LIPOIC ACID	A
4271	RACEMENTHOL	E	Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.
4272	RACEMIC CAMPHOR	E, H	Only for use as an active homoeopathic or excipient ingredient. In solid and semi solid preparations, the concentration of camphor must not be more than 12.5%. In liquid preparations other than essential oils, the concentration of camphor must not be more than 2.5%. In essential oil preparations, if the concentration of camphor is more than 2.5% but less than or equal to 10%, and the nominal capacity of the container is less than 25 millilitres, the medicine must have a restricted flow insert fitted on the container and include the following warning statements on the medicine label: - (CHILD) 'Keep out of reach of children' (or words to that effect); - (NTAKEN) 'Not to be taken'; and - (BABY4) ‘Do not apply to infants under 12 months of age except on the advice of a doctor or pharmacist’ (or words to that effect). In essential oil preparations, if the concentration of camphor is more than 10%, and the nominal capacity of the container is less than 15 millilitres, the medicine must have a restricted flow insert fitted on the container and include the following warning statements on the medicine label: - (CHILD) 'Keep out of reach of children' (or words to that effect); - (NTAKEN) 'Not to be taken'; and - (BABY4) ‘Do not apply to infants under 12 months of age except on the advice of a doctor or pharmacist’ (or words to that effect). In essential oil preparations, if the concentration of camphor is more than 10%, and the nominal capacity of the container is more than 15 millilitres but less than or equal to 25 millilitres, the medicine must have a restricted flow insert and child resistant closure fitted on the container and include the following warning statements on the medicine label: - (CHILD) 'Keep out of reach of children' (or words to that effect); - (NTAKEN) 'Not to be taken'; and - (BABY4) ‘Do not apply to infants under 12 months of age except on the advice of a doctor or pharmacist’ (or words to that effect). If the concentration of camphor is more than 2.5%, the nominal capacity of the container must not be more than 25 millilitres.
4273	RAISIN JUICE CONCENTRATE	E	Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
4274	RANUNCULUS BULBOSUS	A, H
4275	RANUNCULUS FICARIA	A, H
4276	RANUNCULUS TERNATUS	A, H
4277	RAPE SEED OIL	A, E, H	Allyl isothiocyanate is a mandatory component of rape seed oil when the plant part is seed. The concentration of allyl isothiocyanate from all ingredients in the product must be no more than 10 mg/kg or 10 mg/L or 0.001%.
4278	RAPHANUS SATIVUS	A, E, H	When used as an excipient, the plant preparation must be limited to fresh, dry, powder, oil, fresh juice, dry juice, or concentrated juice.
4279	RASPBERRY	E
4280	RASPBERRY BRANDY	E	Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
4281	RASPBERRY DISTILLATE	E	Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
4282	RASPBERRY FRUIT EXTRACT	E	Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
4283	RASPBERRY JUICE CONCENTRATE	E	Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
4284	RAUWOLFIA SERPENTINA	A, H	The concentration of equivalent dry Rauwolfia serpentina in the medicine must be no more than 10mg/Kg or 10mg/L or 0.001%.
4285	RAUWOLFIA SERPENTINA DRY	A, H	The concentration of Rauwolfia Serpentina Dry in the medicine must be no more than 10mg/Kg or 10mg/L or 0.001%.
4286	RAUWOLFIA SERPENTINA POWDER	A, H	The concentration of Rauwolfia Serpentina Powder in the medicine must be no more than 10mg/Kg or 10mg/L or 0.001%.
4287	RED 27	E	Permitted for use only as a colour in medicines limited to topical and oral routes of administration. The concentration in the medicine must be no more than 0.5%.
4288	RED 27 ALUMINIUM LAKE	E	Permitted for use only as a colour in medicines limited to topical and oral routes of administration. The concentration in the medicine must be no more than 0.5%.
4289	RED ANT	H	Only for use as an active homoeopathic ingredient.
4290	RED CLOVER FLOWER DRY	A, H
4291	RED CLOVER FLOWER POWDER	A, H
4292	RED CORAL	H	Only for use as an active homoeopathic ingredient.
4293	RED DEER	A
4294	RED MERCURIC IODIDE	H	Only for use as an active homoeopathic ingredient.
4295	RED MERCURIC OXIDE	H	Only for use as an active homoeopathic ingredient.
4296	RED MERCURIC SULFIDE	H	Only for use as an active homoeopathic ingredient.
4297	REFINED BUGLOSSOIDES ARVENSIS SEED OIL	A	Stearidonic acid is a mandatory component of refined Buglossoides arvensis seed oil. The route of administration for medicines that contain refined Buglossoides arvensis seed oil must be limited to oral. The maximum recommended daily dose of the medicine must not provide more than 500 mg of stearidonic acid. The following warning statement (or words to that effect) is required on the medicine label: - (NTAKEN3) 'Not to be taken by children under 3 years old'.
4298	REHMANNIA GLUTINOSA	A, E, H
4299	REL-1-((1R,2S)-1,2,3,4,5,6,7,8-OCTAHYDRO-1,2,8,8-TETRAMETHYL-2-NAPHTHALENYL)-1-ETHANONE	E	Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.
4300	RESORCINOL	E	Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
4301	RESORCINOL DIMETHYLETHER	E	Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
4302	RESVERATROL	A	Only permitted for use in medicines that are for oral routes of administration. The maximum recommended daily dose of the medicine must not contain more than 150 milligrams of resveratrol. The following warning statements are required on the medicine label: - (RESVER) 'Resveratrol may affect the way some medicines work, including Warfarin. Consult your health professional before taking with other medicines (or words to that effect).'; - (PREGNT) ‘Not recommended for use by pregnant and lactating women’ (or words to that effect)’; and - (CHILD2) ‘Not suitable for children’.
4303	RETINOL	A, E	Vitamin A is a mandatory component of retinol. When for use in topical medicines, the concentration of Vitamin A in the medicine must be no more than 1%. When for internal use, the maximum daily dose must be no more than 3000 micrograms of Retinol Equivalents. When preparations for internal use in adults contain more than 33 micrograms of retinol equivalents per dosage unit in divided preparations or per gram of an undivided preparation, the medicine requires the following warning statements on the medicine label: - (VITA2) ‘WARNING: If you are pregnant - or considering becoming pregnant - do not take Vitamin A supplements without consulting your doctor or pharmacist [or words to that effect].’ NOTE: Position this warning at the beginning of the directions for use. - (VITA4) ‘WARNING - When taken in excess of 3000 micrograms retinol equivalents - Vitamin A can cause birth defects.’ NOTE: Position this warning at the beginning of the directions for use. - (VITA3) ‘The recommended daily amount of Vitamin A from all sources is 700 micrograms retinol equivalents for women and 900 micrograms retinol equivalents for men.’
4304	RETINOL ACETATE	A, E	Vitamin A is a mandatory component of retinol acetate. When for use in topical medicines, the concentration of Vitamin A in the medicine must be no more than 1%. When for internal use, the maximum daily dose must be no more than 3000 micrograms of Retinol Equivalents. When preparations for internal use in adults contain more than 33 micrograms of retinol equivalents per dosage unit in divided preparations or per gram of an undivided preparation, the medicine requires the following warning statements on the medicine label: - (VITA2) ‘WARNING: If you are pregnant - or considering becoming pregnant - do not take Vitamin A supplements without consulting your doctor or pharmacist [or words to that effect].’ NOTE: Position this warning at the beginning of the directions for use. - (VITA4) ‘WARNING - When taken in excess of 3000 micrograms retinol equivalents - Vitamin A can cause birth defects.’ NOTE: Position this warning at the beginning of the directions for use. - (VITA3) ‘The recommended daily amount of Vitamin A from all sources is 700 micrograms retinol equivalents for women and 900 micrograms retinol equivalents for men.’
4305	RETINOL PALMITATE	A, E	Vitamin A is a mandatory component of retinol palmitate. When for use in topical medicines, the concentration of Vitamin A in the medicine must be no more than 1%. When for internal use, the maximum daily dose must be no more than 3000 micrograms of Retinol Equivalents. When preparations for internal use in adults contain more than 33 micrograms of retinol equivalents per dosage unit in divided preparations or per gram of an undivided preparation, the medicine requires the following warning statements on the medicine label: - (VITA2) ‘WARNING: If you are pregnant - or considering becoming pregnant - do not take Vitamin A supplements without consulting your doctor or pharmacist [or words to that effect].’ NOTE: Position this warning at the beginning of the directions for use. - (VITA4) ‘WARNING - When taken in excess of 3000 micrograms retinol equivalents - Vitamin A can cause birth defects.’ NOTE: Position this warning at the beginning of the directions for use. - (VITA3) ‘The recommended daily amount of Vitamin A from all sources is 700 micrograms retinol equivalents for women and 900 micrograms retinol equivalents for men.’
4306	REYNOUTRIA JAPONICA	A, E, H	When used as an excipient, only for use in topical medicines for dermal application.
4307	RHAMNOSE	E	Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
4308	RHAMNUS CATHARTICA	A, H	When the route of administration is oral, Hydroxyanthracene derivatives is a mandatory component of Rhamnus cathartica. When used in oral medicines, if the maximum recommended daily dose contains more than 10 mg of hydroxyanthracene derivatives the medicine requires the following warning statements on the medicine label: - (CHILD3) 'Use in children under 12 years is not recommended'; - (LAX2) 'Prolonged use may cause serious bowel problems'; and - (LAX3) 'Do not use when abdominal pain, nausea or vomiting are present, or if you develop diarrhoea. If you are pregnant or breast feeding, seek the advice of a healthcare professional before taking this product' (or words to that effect). When promoted or marketed as a laxative, the medicine requires the following warning statement on the medicine label: - (LAX1) 'Drink plenty of water' (or words to that effect). When not promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label: - (LAX5) 'This product contains [name of the herb(s) or the chemical component(s)]'; and - (LAX4) 'This product may have laxative effect'. When used in oral medicines, if the maximum recommended daily dose contains less than 10 mg of hydroxyanthracene derivatives and is promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label: - (CHILD3) 'Use in children under 12 years is not recommended'; - (LAX1) 'Drink plenty of water' (or words to that effect); and - (LAX2) 'Prolonged use may cause serious bowel problems'.
4309	RHAMNUS FRANGULA	A, H	Glucofrangulins calculated as glucofrangulin A is a mandatory component of Rhamnus frangula. When used in oral medicines, if the maximum recommended daily dose contains more than 10 mg of hydroxyanthracene derivatives the medicine requires the following warning statements on the medicine label: - (CHILD3) 'Use in children under 12 years is not recommended'; - (LAX2) 'Prolonged use may cause serious bowel problems'; and - (LAX3) 'Do not use when abdominal pain, nausea or vomiting are present, or if you develop diarrhoea. If you are pregnant or breast feeding, seek the advice of a healthcare professional before taking this product' (or words to that effect). When promoted or marketed as a laxative, the medicine requires the following warning statement on the medicine label: - (LAX1) 'Drink plenty of water' (or words to that effect). When not promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label: - (LAX5) 'This product contains [name of the herb(s) or the chemical component(s)]'; and - (LAX4) 'This product may have laxative effect'. When used in oral medicines, if the maximum recommended daily dose contains less than 10 mg of hydroxyanthracene derivatives and is promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label: - (CHILD3) 'Use in children under 12 years is not recommended'; - (LAX1) 'Drink plenty of water' (or words to that effect); and - (LAX2) 'Prolonged use may cause serious bowel problems'.
4310	RHATANY ROOT DRY	A, H
4311	RHATANY ROOT POWDER	A, H
4312	RHEUM OFFICINALE	A, E, H	The plant part must not be leaf. When the route of administration is oral, Hydroxyanthracene derivatives calculated as rhein is a mandatory component of Rheum officinale. When used in oral medicines, if the maximum recommended daily dose contains more than 10 mg of hydroxyanthracene derivatives the medicine requires the following warning statements on the medicine label: - (CHILD3) 'Use in children under 12 years is not recommended'; - (LAX2) 'Prolonged use may cause serious bowel problems'; and - (LAX3) 'Do not use when abdominal pain, nausea or vomiting are present, or if you develop diarrhoea. If you are pregnant or breast feeding, seek the advice of a healthcare professional before taking this product' (or words to that effect). When promoted or marketed as a laxative, the medicine requires the following warning statement on the medicine label: - (LAX1) 'Drink plenty of water' (or words to that effect). When not promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label: - (LAX5) 'This product contains [name of the herb(s) or the chemical component(s)]'; and - (LAX4) 'This product may have laxative effect'. When used in oral medicines, if the maximum recommended daily dose contains less than 10 mg of hydroxyanthracene derivatives and is promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label: - (CHILD3) 'Use in children under 12 years is not recommended'; - (LAX1) 'Drink plenty of water' (or words to that effect); and - (LAX2) 'Prolonged use may cause serious bowel problems'.
4313	RHEUM PALMATUM	A, E, H	The plant part must not be leaf. When the route of administration is oral, Hydroxyanthracene derivatives calculated as rhein is a mandatory component of Rheum palmatum. When used in oral medicines, if the maximum recommended daily dose contains more than 10 mg of hydroxyanthracene derivatives the medicine requires the following warning statements on the medicine label: - (CHILD3) ‘Use in children under 12 years is not recommended’; - (LAX2) ‘Prolonged use may cause serious bowel problems’; and - (LAX3) ‘Do not use when abdominal pain, nausea or vomiting are present, or if you develop diarrhoea. If you are pregnant or breast feeding, seek the advice of a healthcare professional before taking this product' (or words to that effect). When promoted or marketed as a laxative, the medicine requires the following warning statement on the medicine label: - (LAX1) ‘Drink plenty of water' (or words to that effect). When not promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label: - (LAX5) ‘This product contains [name of the herb(s) or the chemical component(s)]’; and - (LAX4) ‘This product may have laxative effect’. When used in oral medicines, if the maximum recommended daily dose contains less than 10 mg of hydroxyanthracene derivatives and is promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label: - (CHILD3) ‘Use in children under 12 years is not recommended’; - (LAX1) ‘Drink plenty of water' (or words to that effect); and - (LAX2) ‘Prolonged use may cause serious bowel problems’.
4314	RHEUM RHAPONTICUM	A, E, H	The plant part must not be leaf. When the route of administration is oral, Hydroxyanthracene derivatives is a mandatory component of Rheum rhaponticum. When used in oral medicines, if the maximum recommended daily dose contains more than 10 mg of hydroxyanthracene derivatives the medicine requires the following warning statements on the medicine label: - (CHILD3) 'Use in children under 12 years is not recommended'; - (LAX2) 'Prolonged use may cause serious bowel problems'; and - (LAX3) 'Do not use when abdominal pain, nausea or vomiting are present, or if you develop diarrhoea. If you are pregnant or breast feeding, seek the advice of a healthcare professional before taking this product' (or words to that effect). When promoted or marketed as a laxative, the medicine requires the following warning statement on the medicine label: - (LAX1) 'Drink plenty of water' (or words to that effect). When not promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label: - (LAX5) 'This product contains [name of the herb(s) or the chemical component(s)]'; and - (LAX4) 'This product may have laxative effect'. When used in oral medicines, if the maximum recommended daily dose contains less than 10 mg of hydroxyanthracene derivatives and is promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label: - (CHILD3) 'Use in children under 12 years is not recommended'; - (LAX1) 'Drink plenty of water' (or words to that effect); and - (LAX2) 'Prolonged use may cause serious bowel problems'.
4315	RHEUM TANGUTICUM	A, H	The plant part must not be leaf. When the route of administration is oral, Hydroxyanthracene derivatives calculated as rhein is a mandatory component of Rheum tanguticum. When used in oral medicines, if the maximum recommended daily dose contains more than 10 mg of hydroxyanthracene derivatives the medicine requires the following warning statements on the medicine label: - (CHILD3) 'Use in children under 12 years is not recommended'; - (LAX2) 'Prolonged use may cause serious bowel problems'; and - (LAX3) 'Do not use when abdominal pain, nausea or vomiting are present, or if you develop diarrhoea. If you are pregnant or breast feeding, seek the advice of a healthcare professional before taking this product' (or words to that effect). When promoted or marketed as a laxative, the medicine requires the following warning statement on the medicine label: - (LAX1) 'Drink plenty of water' (or words to that effect). When not promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label: - (LAX5) 'This product contains [name of the herb(s) or the chemical component(s)]'; and - (LAX4) 'This product may have laxative effect'. When used in oral medicines, if the maximum recommended daily dose contains less than 10 mg of hydroxyanthracene derivatives and is promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label: - (CHILD3) 'Use in children under 12 years is not recommended'; - (LAX1) 'Drink plenty of water' (or words to that effect); and - (LAX2) 'Prolonged use may cause serious bowel problems'.
4316	RHODAMINE B	E	Permitted for use only as a colour for topical use.
4317	RHODINOL	E	Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.
4318	RHODINYL ACETATE	E	Permitted for use only in combination with other permitted ingredients as a flavour. If used as a flavour the total flavour concentration in a medicine must be no more than 5%.
4319	RHODIOLA ROSEA	A	Only for use in oral medicines. Only available for use when the plant preparation is dry root powder, dry root powder as an aqueous extract or dry root powder as a hydroethanolic extract with no more than 70% ethanol v/v.
4320	RHODODENDRON AUREUM	A, H
4321	RHODODENDRON FERRUGINEUM	A, H	Beta-arbutin is a mandatory component of Rhododendron ferrugineum. When for oral use, the maximum recommended daily dose must not provide more than 500 mg of beta-arbutin. When for dermal application exclusively to the face: a) the concentration of beta-arbutin in the medicine must not be more than 7%; b) hydroquinone is a mandatory component; and c) the concentration of hydroquinone must not be more than 10 mg/kg or 10 mg/L or 0.001%. When for use other than oral or dermal application exclusively to the face, the concentration of beta-arbutin in the medicine must not be more than 10 mg/kg or 10 mg/L or 0.001%.
4322	RHODODENDRON GROENLANDICUM	A, H
4323	RHODODENDRON MOLLE	A, H	The maximum recommended daily dose of the medicine must be no more than 1mg of the dry herbal material.
4324	RHUBARB	E, H	When the route of administration is oral, Hydroxyanthracene derivatives is a mandatory component of Rhubarb. When used in oral medicines, if the maximum recommended daily dose contains more than 10 mg of hydroxyanthracene derivatives the medicine requires the following warning statements on the medicine label: - (CHILD3) 'Use in children under 12 years is not recommended'; - (LAX2) 'Prolonged use may cause serious bowel problems'; and - (LAX3) 'Do not use when abdominal pain, nausea or vomiting are present, or if you develop diarrhoea. If you are pregnant or breast feeding, seek the advice of a healthcare professional before taking this product' (or words to that effect). When promoted or marketed as a laxative, the medicine requires the following warning statement on the medicine label: - (LAX1) 'Drink plenty of water' (or words to that effect). When not promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label: - (LAX5) 'This product contains [name of the herb(s) or the chemical component(s)]'; and - (LAX4) 'This product may have laxative effect'. When used in oral medicines, if the maximum recommended daily dose contains less than 10 mg of hydroxyanthracene derivatives and is promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label: - (CHILD3) 'Use in children under 12 years is not recommended'; - (LAX1) 'Drink plenty of water' (or words to that effect); and - (LAX2) 'Prolonged use may cause serious bowel problems'.
4325	RHUBARB ROOT DRY	A, H	When the route of administration is oral, Hydroxyanthracene derivatives calculated as rhein is a mandatory component of rhubarb root dry. When used in oral medicines, if the maximum recommended daily dose contains more than 10 mg of hydroxyanthracene derivatives the medicine requires the following warning statements on the medicine label: - (CHILD3) 'Use in children under 12 years is not recommended'; - (LAX2) 'Prolonged use may cause serious bowel problems'; and - (LAX3) 'Do not use when abdominal pain, nausea or vomiting are present, or if you develop diarrhoea. If you are pregnant or breast feeding, seek the advice of a healthcare professional before taking this product' (or words to that effect). When promoted or marketed as a laxative, the medicine requires the following warning statement on the medicine label: - (LAX1) 'Drink plenty of water' (or words to that effect). When not promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label: - (LAX5) 'This product contains [name of the herb(s) or the chemical component(s)]'; and - (LAX4) 'This product may have laxative effect'. When used in oral medicines, if the maximum recommended daily dose contains less than 10 mg of hydroxyanthracene derivatives and is promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label: - (CHILD3) 'Use in children under 12 years is not recommended'; - (LAX1) 'Drink plenty of water' (or words to that effect); and - (LAX2) 'Prolonged use may cause serious bowel problems'.
4326	RHUBARB ROOT POWDER	A, H	When the route of administration is oral, Hydroxyanthracene derivatives calculated as rhein is a mandatory component of rhubarb root powder. When used in oral medicines, if the maximum recommended daily dose contains more than 10 mg of hydroxyanthracene derivatives the medicine requires the following warning statements on the medicine label: - (CHILD3) 'Use in children under 12 years is not recommended'; - (LAX2) 'Prolonged use may cause serious bowel problems'; and - (LAX3) 'Do not use when abdominal pain, nausea or vomiting are present, or if you develop diarrhoea. If you are pregnant or breast feeding, seek the advice of a healthcare professional before taking this product' (or words to that effect). When promoted or marketed as a laxative, the medicine requires the following warning statement on the medicine label: - (LAX1) 'Drink plenty of water' (or words to that effect). When not promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label: - (LAX5) 'This product contains [name of the herb(s) or the chemical component(s)]'; and - (LAX4) 'This product may have laxative effect'. When used in oral medicines, if the maximum recommended daily dose contains less than 10 mg of hydroxyanthracene derivatives and is promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label: - (CHILD3) 'Use in children under 12 years is not recommended'; - (LAX1) 'Drink plenty of water' (or words to that effect); and - (LAX2) 'Prolonged use may cause serious bowel problems'.
4327	RHUS AROMATICA	A, E, H
4328	RHUS CHINENSIS	A, H
4329	RHUS GLABRA	A, E, H
4330	RHUS VENENATA	H	Only for use as an active homoeopathic ingredient.
4331	RIBES GROSSULARIA	A, E, H
4332	RIBES NIGRUM	A, E, H
4333	RIBOFLAVIN	A, E
4334	RIBOFLAVIN SODIUM PHOSPHATE	A, E
4335	RIBOFLAVIN TETRAACETATE	E	Only for use in topical medicines for dermal application.
4336	RIBOFLAVINE	A, E
4337	RIBOFLAVINE SODIUM PHOSPHATE	A, E
4338	RIBONUCLEIC ACID	E	Only for use in topical medicines for dermal application.
4339	RIBOSE	A	Only for use in oral medicines.
4340	RICE	E
4341	RICE BRAN	E
4342	RICE BRAN OIL	E
4343	RICE BRAN WAX	A, E, H
4344	RICE STARCH	E
4345	RICE VINEGAR	E
4346	RICE WINE	E	Ethanol is a mandatory component of rice wine.
4347	RICINOLEIC ACID	E	Only for use in topical medicines for dermal application.
4348	RICINUS COMMUNIS	A, H	Only for use when the plant part must be seed and the plant preparation is oil fixed.
4349	ROBINIA PSEUDOACACIA	A, E, H	When the herbal substance is derived from plant parts other than the leaf or flower, the maximum recommended daily dose of the medicine must be no more than 1mg of the dry herbal material.
4350	ROHDEA JAPONICA	A, H	The maximum recommended daily dose must be no more than the equivalent of 1mg of the dry herbal material.
4351	ROSA ARVENSIS	A, E, H
4352	ROSA CANINA	A, E, H
4353	ROSA CYMOSA	A, E, H
4354	ROSA EGLANTERIA	A, E, H
4355	ROSA GALLICA	A, E, H
4356	ROSA LAEVIGATA	A, E, H
4357	ROSA MULTIFLORA	A, E, H
4358	ROSA ROXBURGHII FRUIT EXTRACT	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.002%.
4359	ROSA RUGOSA	A, E, H
4360	ROSA VILLOSA	A, E, H
4361	ROSA X CENTIFOLIA	A, E, H
4362	ROSA X DAMASCENA	A, E, H
4363	ROSANA	E	Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.
4364	ROSE ABSOLUTE	E	Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.
4365	ROSE FRUIT FRESH	A, E, H
4366	ROSE HIP	E
4367	ROSE OIL	A, E, H
4368	ROSE OXIDE	E	Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.
4369	ROSEMARY OIL	A, E, H	Safrole is a mandatory component of Rosemary oil. When for internal use then the concentration of safrole in the medicine must be no more than 0.1%. When for topical use then the concentration of safrole in the medicine must be no more than 1%.
4370	ROSMARINUS OFFICINALIS	A, E, H	Camphor and cineole are mandatory components of Rosmarinus officinalis except when the plant preparation is an essential oil or distillate. In solid and semi-solid preparations, the concentration of camphor must not be more than 12.5%. In liquid preparations other than essential oils or distillates, the concentration of camphor must not be more than 2.5%. When the concentration of cineole in the preparation other than essential oils or distillates is more than 25%, the nominal capacity of the container must not be more than 25 millilitres. In liquid preparations other than essential oils or distillates, when the concentration of cineole in the preparation is more than 25% and the nominal capacity of the container is more than 15 millilitres but less than or equal to 25 millilitres, the medicine must have a child resistant closure and restricted flow insert fitted on the container and include the following warning statements on the medicine label: - (CHILD) 'Keep out of reach of children' (or words to that effect); and - (NTAKEN) 'Not to be taken'. In liquid preparations other than essential oils or distillates, when the concentration of cineole in the preparation is more than 25% and the nominal capacity of the container is no more than 15 millilitres, the medicine must have a restricted flow insert fitted on the container and include the following warning statements on the medicine label: - (CHILD) 'Keep out of reach of children' (or words to that effect); and - (NTAKEN) 'Not to be taken'.
4371	ROYAL JELLY	A, E	10-Hydroxy-2-decenoic acid is a mandatory component of Royal jelly. The medicine requires the following warning statements on the medicine label: - (CHILD2) 'Not suitable for children' - (ROYJ) 'Not to be taken by asthma and allergy sufferers' in 3 mm type, prominent on front and 'This product contains royal jelly which has been reported to cause severe allergic reactions and in rare cases fatalities, especially in asthma and allergy sufferers'.
4372	ROYAL JELLY FRESH	A, E	10-Hydroxy-2-decenoic acid is a mandatory component of Royal jelly fresh. The medicine requires the following warning statements on the medicine label: - (CHILD2) 'Not suitable for children' - (ROYJ) 'Not to be taken by asthma and allergy sufferers' in 3 mm type, prominent on front and 'This product contains royal jelly which has been reported to cause severe allergic reactions and in rare cases fatalities, especially in asthma and allergy sufferers'.
4373	ROYAL JELLY LYOPHILISED	A, E	10-Hydroxy-2-decenoic acid is a mandatory component of Royal jelly lyophilised. The medicine requires the following warning statements on the medicine label: - (CHILD2) 'Not suitable for children' - (ROYJ) 'Not to be taken by asthma and allergy sufferers' in 3 mm type, prominent on front and 'This product contains royal jelly which has been reported to cause severe allergic reactions and in rare cases fatalities, especially in asthma and allergy sufferers'.
4374	RUBBER NATURAL	E	Only for use in topical medicines for dermal application.
4375	RUBIA CORDIFOLIA	A, H
4376	RUBIA TINCTORUM	A, H
4377	RUBUS CHINGII	A, H
4378	RUBUS CORCHORIFOLIUS	A, H
4379	RUBUS COREANUS	A, E, H
4380	RUBUS FRUTICOSUS	A, E, H
4381	RUBUS IDAEUS	A, E, H
4382	RUBUS OCCIDENTALIS	A, E, H
4383	RUBUS PARVIFOLIUS	A, H
4384	RUBUS ROSIFOLIUS	A, H
4385	RUDBECKIA HIRTA	A, H
4386	RUE OIL	A, E, H	The requirements specified below apply to a medicine that contains the ingredient that is: - listed in the Register on or after 1 March 2025; or - released for supply on or after 1 March 2026. When used as an active ingredient: (a) Rue oil must only be used as a homoeopathic ingredient; (b) the routes of administration for medicines that contain rue oil must be limited to: (i) topical for dermal use; and (ii) oral; (c) when the homoeopathic potency of the medicine containing rue oil is 12X or lower, the following warning statement is required on the medicine label: - (PREGNT3) ‘Do not use if pregnant or likely to become pregnant, or during lactation.’; and (d) when the medicine is for dermal use, the following statement is required on the medicine: - (SENS) ‘Application to skin may increase sensitivity to sunlight’ (or words to that effect). When used as an excipient ingredient: (a) the route of administration for medicines that contain rue oil must be limited to topical; (b) rue oil must only be included in combination with other permitted ingredients as a fragrance proprietary excipient formulation; (c) the total concentration of fragrance proprietary excipient formulations containing rue oil must not be more than 1% of the total medicine; and (d) the total concentration of rue oil in the medicine must not be more than 0.15%.
4387	RUM	E	Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
4388	RUMEX ACETOSA	A, H
4389	RUMEX ACETOSELLA	A, H
4390	RUMEX CONGLOMERATUS	A, H
4391	RUMEX CRISPUS	A, E, H
4392	RUMEX PULCHER	A, H
4393	RUMEX SCUTATUS	A, H
4394	RUSCUS ACULEATUS	A, H
4395	RUTA GRAVEOLENS	A, E, H	The requirements specified below apply to a medicine that contains the ingredient that is: - listed in the Register on or after 1 March 2025; or - released for supply on or after 1 March 2026. When used as an active ingredient: (a) Ruta graveolens must only be used as a homoeopathic ingredient; (b) the routes of administration for medicines that contain Ruta graveolens must be limited to: (i) topical for dermal use; and (ii) oral; (c) when the homoeopathic potency of the medicine containing Ruta graveolens is 12X or lower, the following warning statement is required on the medicine label: - (PREGNT3) ‘Do not use if pregnant or likely to become pregnant, or during lactation.’; and (d) when the medicine is for dermal use, the following statement is required on the medicine: - (SENS) ‘Application to skin may increase sensitivity to sunlight’ (or words to that effect). When used as an excipient ingredient: (a) the route of administration for medicines that contain Ruta graveolens must be limited to topical; (b) Ruta graveolens must only be included in combination with other permitted ingredients as a fragrance proprietary excipient formulation; (c) the total concentration of fragrance proprietary excipient formulations containing Ruta graveolens must not be more than 1% of the total medicine; and (d) the total concentration of Ruta graveolens in the medicine must not be more than 0.15%.
4396	RUTOSIDE	A, E
4397	RUTOSIDE TRIHYDRATE	A, E
4398	RYE	E	Gluten is a mandatory component of Rye when the route of administration is other than topical and mucosal.
4399	RYE BRAN	E	Gluten is a mandatory component of Rye bran when the route of administration is other than topical and mucosal.
4400	S-ISOPROPYL 3-METHYLTHIOCROTONATE	E	Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.
4401	SABINENE	E	Sabinene must only be included in medicines when in combination with other permitted ingredients as a flavour proprietary excipient formulation. The total concentration of flavour proprietary excipient formulations containing sabinene must not be more than 5% of the total medicine.
4402	SABINENE HYDRATE	E	Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
4403	SACCHARIDE ISOMERATE	E	Only for use in topical medicines for dermal application and not to be included in medicines for use in the eye or on damaged skin. The concentration in the medicine must be no more than 3.66%.
4404	SACCHARIN	E
4405	SACCHARIN SODIUM	E
4406	SACCHAROMYCES CEREVISIAE	A, E	When for topical use, the concentration in the medicine must be no more than 1%.
4407	SACCHAROMYCES CEREVISIAE (BOULARDII)	A
4408	SACCHAROMYCES CEREVISIAE POLYSACCHARIDES	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 1%.
4409	SACCHAROMYCES/ZINC FERMENT	E	Only for use in topical medicines for dermal application.
4410	SACCHARUM OFFICINARUM	A, E, H
4411	SAFFLOWER OIL	A, E, H
4412	SAFFRON	E	Permitted for use only as a colour for either topical use or with an oral route of administration.
4413	SAGE LEAF DRY	A, E, H	Thujone is a mandatory component of Sage leaf dry. The concentration of thujone in the medicine must be no more than 4%.
4414	SAGE LEAF POWDER	A, H	Thujone is a mandatory component of Sage leaf powder. The concentration of thujone in the medicine must be no more than 4%.
4415	SAGE OIL DALMATIAN	A	Thujone is a mandatory component of Sage oil dalmatian. The concentration of thujone in the medicine must be no more than 4%. When the concentration of Sage oil dalmatian in the medicine is more than 10% and the nominal capacity of the container is no more than 15 mL, a restricted flow insert and child resistant closure must be fitted on the container and the medicine requires the following warning statements on the medicine label: - (CHILD) ‘Keep out of reach of children’ (or word to that effect) - (NTAKEN) ‘Not to be taken’
4416	SAGE OIL SPANISH	A, E, H
4417	SALICORNIA EUROPAEA EXTRACT	E	Only for use in topical medicines for dermal use and not to be included in medicines intended for use in the eye or on damaged skin. The concentration in the medicine must be no more than 0.002%.
4418	SALICYLALDEHYDE	E	Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.
4419	SALICYLIC ACID	E, H	Only for use in topical medicines for dermal application. The concentration in the medicine must be no more than 40%.
4420	SALIX ALBA	A, E, H
4421	SALIX DAPHNOIDES	A, H
4422	SALIX DISCOLOR	A, H
4423	SALIX FRAGILIS	A, H
4424	SALIX NIGRA	A, H
4425	SALIX PURPUREA	A, H
4426	SALSOLA KALI	A, H
4427	SALVIA CHINENSIS	A, H
4428	SALVIA FRUTICOSA	A, H
4429	SALVIA HISPANICA	A, E, H
4430	SALVIA LAVANDULAEFOLIA	A, H
4431	SALVIA MILTIORRHIZA	A, H
4432	SALVIA OFFICINALIS	A, E, H	Thujone is a mandatory component of Salvia officinalis. The concentration of thujone in the medicine must be no more than 4%.
4433	SALVIA SCLAREA	A, E, H
4434	SAMBUCUS CANADENSIS	A, H
4435	SAMBUCUS EBULUS	A, H
4436	SAMBUCUS NIGRA	A, E, H
4437	SANDALWOOD OIL EAST INDIAN	A, E, H
4438	SANGUINARIA CANADENSIS	H	Only for use as an active homoeopathic ingredient. The potency must be more than 4X.
4439	SANICULA EUROPAEA	A, H
4440	SANTALUM ALBUM	A, E, H
4441	SANTALUM SPICATUM	A, E, H	The route of administration must be topical or inhalation. The plant preparation must be oil. The plant part must be root or stem wood including heartwood.
4442	SAPINDUS MUKOROSSI	A, H
4443	SAPONARIA OFFICINALIS	A, H
4444	SAPOSHNIKOVIA DIVARICATA	A, H
4445	SARCOSINE	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.5%.
4446	SARGASSUM FUSIFORME	A, H	Iodine is a mandatory component of Sargassum fusiforme. Only for external use when the concentration of iodine in the medicine (excluding salts derivatives or iodophors) is 2.5% or less. Only for internal use when the medicine contains less than 300 micrograms of iodine per maximum recommended daily dose.
4447	SARGASSUM SILIQUASTRUM	A, H	Iodine is a mandatory component of Sargassum siliquastrum. Only for external use when the concentration of iodine in the medicine (excluding salts derivatives or iodophors) is 2.5% or less. Only for internal use when the medicine contains less than 300 micrograms of iodine per maximum recommended daily dose.
4448	SASSAFRAS ALBIDUM	A, H	Safrole is a mandatory component of Sassafras albidum. When for internal use then the concentration of safrole in the medicine must be no more than 0.1%. When for topical use then the concentration of safrole in the medicine must be no more than 1%.
4449	SATUREIA HORTENSIS	A, H
4450	SATUREIA MONTANA	A, H
4451	SAUROPUS SPATULIFOLIUS	A, H
4452	SAURURUS CHINENSIS	A, H
4453	SAUSSUREA COSTUS	A, H
4454	SAVORY OIL SUMMER	A, H
4455	SAXIFRAGA GRANULATA	A, E, H
4456	SAXIFRAGA STOLONIFERA	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must not be more than 0.0816%.
4457	SCAPHIUM SCAPHIGERUM	A, H
4458	SCHEFFLERA HEPTAPHYLLA	A, H
4459	SCHINOPSIS QUEBRACHO-COLORADO	A, H
4460	SCHINUS MOLLE	A, H
4461	SCHINUS MOLLE OIL	E	Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.
4462	SCHISANDRA CHINENSIS	A, E, H
4463	SCHIZONEPETA TENUIFOLIA	A, E, H
4464	SCHOENOCAULON OFFICINALE	A, H	The maximum recommended daily dose of the medicine must not contain more than the equivalent of 1 mg of the dry herbal material. The concentration of total alkaloids of Schoenocaulon officinale in the medicine must not be more than 10 mg/kg or 10 mg/L or 0.001%.
4465	SCLAREOL	E	Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
4466	SCLAREOLIDE	E	Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.
4467	SCLERANTHUS ANNUUS	A, H
4468	SCLEROTIUM GUM	E	Only for use in topical medicines for dermal application.
4469	SCOPOLIA CARNIOLICA	A, H	The concentration of equivalent dry Scopolia carniolica in the medicine must be no more than 10mg/Kg or 10mg/L or 0.001%.
4470	SCROPHULARIA NINGPOENSIS	A, H
4471	SCROPHULARIA NODOSA	A, H
4472	SCURRULA PARASITICA VAR. GRACILIFLORA	A, H
4473	SCUTELLARIA BAICALENSIS	A, E, H
4474	SCUTELLARIA BARBATA	A, H
4475	SCUTELLARIA LATERIFLORA	A, E, H
4476	SEA WHIP EXTRACT	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.02%.
4477	SEC BUTYL 3-METHYLBUT-2-ENETHIOATE	E	Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.
4478	SEC-BUTYL THIOISOVALERATE	E	Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.
4479	SECALE CEREALE	A, H	Gluten is a mandatory component of Secale cereale when the plant part is seed and the route of administration is other than topical and mucosal.
4480	SEDUM ACRE	A, H
4481	SELAGINELLA TAMARISCINA	A, H
4482	SELENICEREUS GRANDIFLORUS	A, E, H
4483	SELENIUM	H	Only for use as an active homoeopathic ingredient. Oral medicines must contain no more than 150 micrograms of selenium per maximum recommended daily dose. When for oral use, the medicine requires the following warning statement on the medicine label: - (SELE) 'This medicine contains selenium which is toxic in high doses. A daily dose of 150 micrograms for adults of selenium from dietary supplements should not be exceeded.'
4484	SELENOCYSTEINE	A	Selenium is a mandatory component of Selenocysteine for oral and sublingual use. Oral medicines must contain no more than 150 micrograms of selenium per maximum recommended daily dose. When for oral use, the medicine requires the following warning statement on the medicine label: - (SELE) 'This medicine contains selenium which is toxic in high doses. A daily dose of 150 mcg for adults of selenium from dietary supplements should not be exceeded.'
4485	SELENOMETHIONINE	A	Selenium is a mandatory component of Selenomethionine for oral and sublingual use. Oral medicines must not contain more than 150 micrograms of selenium per maximum recommended daily dose. When for oral use, the medicine requires the following warning statement on the medicine label: - (SELE) 'This medicine contains selenium which is toxic in high doses. A daily dose of 150 micrograms for adults of selenium from dietary supplements should not be exceeded.’
4486	SELF-EMULSIFYING GLYCERYL MONOSTEARATE	E
4487	SEMECARPUS ANACARDIUM	A, H	When the plant part is other than seed, the maximum recommended daily dose must be no more than 1mg of the equivalent dry herbal material.
4488	SEMOLINA	E
4489	SEMPERVIVUM TECTORUM	A, H
4490	SENEGA ROOT DRY	A, H
4491	SENEGA ROOT POWDER	A, H
4492	SENNA ALEXANDRINA	A, H	When for oral or sublingual use, Hydroxyanthracene glycosides calculated as sennoside B is a mandatory component of Senna alexandrina. When used in oral medicines, if the maximum recommended daily dose contains more than 10 mg of hydroxyanthracene derivatives the medicine requires the following warning statements on the medicine label: - (CHILD3) 'Use in children under 12 years is not recommended'; - (LAX2) 'Prolonged use may cause serious bowel problems'; and - (LAX3) 'Do not use when abdominal pain, nausea or vomiting are present, or if you develop diarrhoea. If you are pregnant or breast feeding, seek the advice of a healthcare professional before taking this product' (or words to that effect). When promoted or marketed as a laxative, the medicine requires the following warning statement on the medicine label: - (LAX1) 'Drink plenty of water' (or words to that effect). When not promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label: - (LAX5) 'This product contains [name of the herb(s) or the chemical component(s)]'; and - (LAX4) 'This product may have laxative effect'. When used in oral medicines, if the maximum recommended daily dose contains less than 10 mg of hydroxyanthracene derivatives and is promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label: - (CHILD3) 'Use in children under 12 years is not recommended'; - (LAX1) 'Drink plenty of water' (or words to that effect); and - (LAX2) 'Prolonged use may cause serious bowel problems'.
4493	SENNA FRUIT ALEXANDRIAN DRY	A, H	When for oral or sublingual use, Hydroxyanthracene glycosides calculated as sennoside B is a mandatory component of Senna fruit alexandrian dry. When used in oral medicines, if the maximum recommended daily dose contains more than 10 mg of hydroxyanthracene derivatives the medicine requires the following warning statements on the medicine label: - (CHILD3) 'Use in children under 12 years is not recommended'; - (LAX2) 'Prolonged use may cause serious bowel problems'; and - (LAX3) 'Do not use when abdominal pain, nausea or vomiting are present, or if you develop diarrhoea. If you are pregnant or breast feeding, seek the advice of a healthcare professional before taking this product' (or words to that effect). When promoted or marketed as a laxative, the medicine requires the following warning statement on the medicine label: - (LAX1) 'Drink plenty of water' (or words to that effect). When not promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label: - (LAX5) 'This product contains [name of the herb(s) or the chemical component(s)]'; and - (LAX4) 'This product may have laxative effect'. When used in oral medicines, if the maximum recommended daily dose contains less than 10 mg of hydroxyanthracene derivatives and is promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label: - (CHILD3) 'Use in children under 12 years is not recommended'; - (LAX1) 'Drink plenty of water' (or words to that effect); and - (LAX2) 'Prolonged use may cause serious bowel problems'.
4494	SENNA FRUIT ALEXANDRIAN POWDER	A, H	When for oral or sublingual use, Hydroxyanthracene glycosides calculated as sennoside B is a mandatory component of Senna fruit alexandrian powder. When used in oral medicines, if the maximum recommended daily dose contains more than 10 mg of hydroxyanthracene derivatives the medicine requires the following warning statements on the medicine label: - (CHILD3) 'Use in children under 12 years is not recommended'; - (LAX2) 'Prolonged use may cause serious bowel problems'; and - (LAX3) 'Do not use when abdominal pain, nausea or vomiting are present, or if you develop diarrhoea. If you are pregnant or breast feeding, seek the advice of a healthcare professional before taking this product' (or words to that effect). When promoted or marketed as a laxative, the medicine requires the following warning statement on the medicine label: - (LAX1) 'Drink plenty of water' (or words to that effect). When not promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label: - (LAX5) 'This product contains [name of the herb(s) or the chemical component(s)]'; and - (LAX4) 'This product may have laxative effect'. When used in oral medicines, if the maximum recommended daily dose contains less than 10 mg of hydroxyanthracene derivatives and is promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label: - (CHILD3) 'Use in children under 12 years is not recommended'; - (LAX1) 'Drink plenty of water' (or words to that effect); and - (LAX2) 'Prolonged use may cause serious bowel problems'.
4495	SENNA FRUIT TINNEVELLY DRY	A, H	When for oral or sublingual use, Hydroxyanthracene glycosides calculated as sennoside B is a mandatory component of Senna fruit tinnevelly dry. When used in oral medicines, if the maximum recommended daily dose contains more than 10 mg of hydroxyanthracene derivatives the medicine requires the following warning statements on the medicine label: - (CHILD3) 'Use in children under 12 years is not recommended'; - (LAX2) 'Prolonged use may cause serious bowel problems'; and - (LAX3) 'Do not use when abdominal pain, nausea or vomiting are present, or if you develop diarrhoea. If you are pregnant or breast feeding, seek the advice of a healthcare professional before taking this product' (or words to that effect). When promoted or marketed as a laxative, the medicine requires the following warning statement on the medicine label: - (LAX1) 'Drink plenty of water' (or words to that effect). When not promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label: - (LAX5) 'This product contains [name of the herb(s) or the chemical component(s)]'; and - (LAX4) 'This product may have laxative effect'. When used in oral medicines, if the maximum recommended daily dose contains less than 10 mg of hydroxyanthracene derivatives and is promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label: - (CHILD3) 'Use in children under 12 years is not recommended'; - (LAX1) 'Drink plenty of water' (or words to that effect); and - (LAX2) 'Prolonged use may cause serious bowel problems'.
4496	SENNA FRUIT TINNEVELLY POWDER	A, H	When for oral or sublingual, Hydroxyanthracene glycosides calculated as sennoside B is a mandatory component of Senna fruit tinnevelly powder. When used in oral medicines, if the maximum recommended daily dose contains more than 10 mg of hydroxyanthracene derivatives the medicine requires the following warning statements on the medicine label: - (CHILD3) 'Use in children under 12 years is not recommended'; - (LAX2) 'Prolonged use may cause serious bowel problems'; and - (LAX3) 'Do not use when abdominal pain, nausea or vomiting are present, or if you develop diarrhoea. If you are pregnant or breast feeding, seek the advice of a healthcare professional before taking this product' (or words to that effect). When promoted or marketed as a laxative, the medicine requires the following warning statement on the medicine label: - (LAX1) 'Drink plenty of water' (or words to that effect). When not promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label: - (LAX5) 'This product contains [name of the herb(s) or the chemical component(s)]'; and - (LAX4) 'This product may have laxative effect'. When used in oral medicines, if the maximum recommended daily dose contains less than 10 mg of hydroxyanthracene derivatives and is promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label: - (CHILD3) 'Use in children under 12 years is not recommended'; - (LAX1) 'Drink plenty of water' (or words to that effect); and - (LAX2) 'Prolonged use may cause serious bowel problems'.
4497	SENNA LEAF DRY	A, H	When for oral or sublingual use, Hydroxyanthracene glycosides calculated as sennoside B is a mandatory component of Senna leaf dry. When used in oral medicines, if the maximum recommended daily dose contains more than 10 mg of hydroxyanthracene derivatives the medicine requires the following warning statements on the medicine label: - (CHILD3) 'Use in children under 12 years is not recommended'; - (LAX2) 'Prolonged use may cause serious bowel problems'; and - (LAX3) 'Do not use when abdominal pain, nausea or vomiting are present, or if you develop diarrhoea. If you are pregnant or breast feeding, seek the advice of a healthcare professional before taking this product' (or words to that effect). When promoted or marketed as a laxative, the medicine requires the following warning statement on the medicine label: - (LAX1) 'Drink plenty of water' (or words to that effect). When not promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label: - (LAX5) 'This product contains [name of the herb(s) or the chemical component(s)]'; - (LAX4) 'This product may have laxative effect'. When used in oral medicines, if the maximum recommended daily dose contains less than 10 mg of hydroxyanthracene derivatives and is promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label: - (CHILD3) 'Use in children under 12 years is not recommended'; - (LAX1) 'Drink plenty of water' (or words to that effect); and - (LAX2) 'Prolonged use may cause serious bowel problems'.
4498	SENNA LEAF POWDER	A, H	When for oral or sublingual use, Hydroxyanthracene glycosides calculated as sennoside B is a mandatory component of Senna Leaf Powder. When used in oral medicines, if the maximum recommended daily dose contains more than 10 mg of hydroxyanthracene derivatives the medicine requires the following warning statements on the medicine label: - (CHILD3) 'Use in children under 12 years is not recommended'; - (LAX2) 'Prolonged use may cause serious bowel problems'; and - (LAX3) 'Do not use when abdominal pain, nausea or vomiting are present, or if you develop diarrhoea. If you are pregnant or breast feeding, seek the advice of a healthcare professional before taking this product' (or words to that effect). When promoted or marketed as a laxative, the medicine requires the following warning statement on the medicine label: - (LAX1) 'Drink plenty of water' (or words to that effect). When not promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label: - (LAX5) 'This product contains [name of the herb(s) or the chemical component(s)]'; and - (LAX4) 'This product may have laxative effect'. When used in oral medicines, if the maximum recommended daily dose contains less than 10 mg of hydroxyanthracene derivatives and is promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label: - (CHILD3) 'Use in children under 12 years is not recommended'; - (LAX1) 'Drink plenty of water' (or words to that effect); and - (LAX2) 'Prolonged use may cause serious bowel problems'.
4499	SENNA OCCIDENTALIS	A, H	Hydroxyanthracene glycosides calculated as sennoside B is a mandatory component of Senna occidentalis when the route of administration is oral administration. When used in oral medicines, if the maximum recommended daily dose contains more than 10 mg of hydroxyanthracene derivatives the medicine requires the following warning statements on the medicine label: - (CHILD3) 'Use in children under 12 years is not recommended'; - (LAX2) 'Prolonged use may cause serious bowel problems'; and - (LAX3) 'Do not use when abdominal pain, nausea or vomiting are present, or if you develop diarrhoea. If you are pregnant or breast feeding, seek the advice of a healthcare professional before taking this product' [or words to that effect]. When promoted or marketed as a laxative, the medicine requires the following warning statement on the medicine label: - (LAX1) 'Drink plenty of water' [or words to that effect]. When not promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label: - (LAX5) 'This product contains [name of the herb(s) or the chemical component(s)]'; and - (LAX4) 'This product may have laxative effect'. When used in oral medicines, if the maximum recommended daily dose contains less than 10 mg of hydroxyanthracene derivatives and is promoted or marketed as laxative, the medicine the following warning statements on the medicine label: - (CHILD3) 'Use in children under 12 years is not recommended; - (LAX1) 'Drink plenty of water' [or words to that effect]; and - (LAX2) 'Prolonged use may cause serious bowel problems'.
4500	SENNA TORA	A, H	When for oral or sublingual use, Hydroxyanthracene glycosides calculated as sennoside B is a mandatory component of Senna tora. When used in oral medicines, if the maximum recommended daily dose contains more than 10 mg of hydroxyanthracene derivatives the medicine requires the following warning statements on the medicine label: - (CHILD3) 'Use in children under 12 years is not recommended'; - (LAX2) 'Prolonged use may cause serious bowel problems'; and - (LAX3) 'Do not use when abdominal pain, nausea or vomiting are present, or if you develop diarrhoea. If you are pregnant or breast feeding, seek the advice of a healthcare professional before taking this product' (or words to that effect). When promoted or marketed as a laxative, the medicine requires the following warning statement on the medicine label: - (LAX1) 'Drink plenty of water' (or words to that effect). When not promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label: - (LAX5) 'This product contains [name of the herb(s) or the chemical component(s)]'; and - (LAX4) 'This product may have laxative effect'. When used in oral medicines, if the maximum recommended daily dose contains less than 10 mg of hydroxyanthracene derivatives and is promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label: - (CHILD3) 'Use in children under 12 years is not recommended'; - (LAX1) 'Drink plenty of water' (or words to that effect); and - (LAX2) 'Prolonged use may cause serious bowel problems'.
4501	SEPIA	H	Only for use as an active homoeopathic ingredient. The following warning statement is required on the medicine label: - (MOLLUSC) ‘Contains mollusc’ or ’Contains mollusc products’.
4502	SEQUOIA SEMPERVIRENS	A, H
4503	SEQUOIADENDRON GIGANTEUM	A, H
4504	SERENOA REPENS	A, H
4505	SERINE	A, E
4506	SERUM ANGUILLAE	H	Only for use as an active homoeopathic ingredient.
4507	SESAME OIL	A, E, H
4508	SESAMUM INDICUM	A, E, H
4509	SETARIA ITALICA	A, H
4510	SHARK CALCIUM CHONDROITIN SULFATE	A
4511	SHARK CARTILAGE	A, E	The medicine requires the following warning statement on the medicine label: - (SHARK) 'Children, pregnant or breastfeeding women, and those who have recently had a heart attack, surgery or a major accident should not consume this product without medical advice' (or words to that effect)
4512	SHARK CHONDROITIN SULFATE	A, E	When used as an excipient: - only for use in topical medicines for dermal application; - not to be included in medicines intended for use in the eye; and - the concentration in the medicine must be no more than 0.001%.
4513	SHARK POTASSIUM CHONDROITIN SULFATE	A
4514	SHARK SODIUM CHONDROITIN SULFATE	A, E	When used as an excipient: - only for use in topical medicines for dermal application; - not to be included in medicines intended for use in the eye; and - the concentration in the medicine must be no more than 0.001%.
4515	SHARK-LIVER OIL	A, E	Vitamin A and Colecalciferol are mandatory components of Shark-liver oil. When for internal use, the maximum recommended daily dose must be no more than 25 micrograms of Vitamin D. When for use in topical medicines, the concentration of Vitamin A in the medicine must be no more than 1%. When for internal use, the maximum daily dose must be no more than 3000 micrograms of Retinol Equivalents. When preparations for internal use in adults contain more than 33 micrograms of retinol equivalents per dosage unit in divided preparations or per gram of an undivided preparation, the medicine requires the following warning statements on the medicine label: - (VITA2) ‘WARNING: If you are pregnant - or considering becoming pregnant - do not take vitamin A supplements without consulting your doctor or pharmacist [or words to that effect].’ NOTE: Position this warning at the beginning of the directions for use. - (VITA4) ‘WARNING - When taken in excess of 3000 micrograms retinol equivalents - vitamin A can cause birth defects.’ NOTE: Position this warning at the beginning of the directions for use. - (VITA3) ‘The recommended daily amount of vitamin A from all sources is 700 micrograms retinol equivalents for women and 900 micrograms retinol equivalents for men.’
4516	SHEA BUTTER	E
4517	SHEA BUTTER ETHYL ESTERS	E	Shea butter ethyl esters must: (a) Only be used in topical medicines for dermal application; and (b) Not be included in medicines intended for use on broken skin. The total concentration of shea butter ethyl esters in the medicine must not be more than 30%.
4518	SHEA BUTTER UNSAPONIFIABLES	E	Only for use in topical medicines for dermal application.
4519	SHELLAC	E
4520	SHEPHERD'S PURSE HERB DRY	A, H
4521	SHEPHERD'S PURSE HERB POWDER	A, H
4522	SHERRY WINE	E	Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
4523	SIGESBECKIA ORIENTALIS	A, E, H
4524	SILICA	E	Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
4525	SILICA DIMETHYL SILYLATE	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 4%.
4526	SILICA SILYLATE	E	Only for use in topical medicines for dermal application.
4527	SILICIFIED MICROCRYSTALLINE CELLULOSE	E	Only for use when the route of administration is other than inhalation.
4528	SILICON DIOXIDE	A, E, H	Only for use when the route of administration is other than inhalation.
4529	SILICONE QUATERNIUM-8	E	Only for use in wash-off topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 2.5%. The medicine requires the following warning statement on the medicine label: - (EYE) 'Avoid contact with eyes' (or words to that effect).
4530	SILVER	H	Only for use as an active homoeopathic ingredient. When for external use, the total concentration of silver in the medicine must not be more than 1%. When for oral use: (a) the total concentration of silver in the medicine must not be more than 0.3%; and (b) the following warning statement is required on the medicine label: - ‘Overuse may stain skin or mouth.’ (or words to that effect).
4531	SILVER BOROSILICATE	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine should be no more than 0.6%. Silver is a mandatory component of Silver borosilicate when the route of administration is topical. The concentration of silver in the medicine must be no more than 1%.
4532	SILVER NITRATE	H	Only for use as an active homoeopathic ingredient.
4533	SILYBUM MARIANUM	A, E, H
4534	SIMABA CEDRON	A, H
4535	SIMETHICONE	E
4536	SIMMONDSIA CHINENSIS	A, E, H
4537	SINAPIS ALBA	A, H	Allyl isothiocyanate is a mandatory component of Sinapis alba when the plant part is seed. The concentration of allyl isothiocyanate from all ingredients in the product must be no more than 10 mg/kg or 10 mg/L or 0.001%.
4538	SINAPIS ARVENSIS	A, H
4539	SINOMENIUM ACUTUM	A, H
4540	SIPHONESTEGIA CHINENSIS	A, H
4541	SIRAITIA GROSVENORII	A, E, H
4542	SISYMBRIUM OFFICINALE	A, H
4543	SKATOLE	E	Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.
4544	SKIPJACK-LIVER OIL	A, E	Vitamin A and Colecalciferol are mandatory components of Skipjack-liver oil. When for internal use, the maximum recommended daily dose must be no more than 25 micrograms of Vitamin D. When for use in topical medicines, the concentration of Vitamin A in the medicine must be no more than 1%. When for internal use, the maximum daily dose must be no more than 3000 micrograms of Retinol Equivalents. When preparations for internal use in adults contain more than 33 micrograms of retinol equivalents per dosage unit in divided preparations or per gram of an undivided preparation, the medicine requires the following warning statements on the medicine label: - (VITA2) ‘WARNING: If you are pregnant - or considering becoming pregnant - do not take vitamin A supplements without consulting your doctor or pharmacist [or words to that effect].’ NOTE: Position this warning at the beginning of the directions for use. - (VITA4) ‘WARNING - When taken in excess of 3000 micrograms retinol equivalents - vitamin A can cause birth defects.’ NOTE: Position this warning at the beginning of the directions for use. - (VITA3) ‘The recommended daily amount of vitamin A from all sources is 700 micrograms retinol equivalents for women and 900 micrograms retinol equivalents for men.’
4545	SLIPPERY ELM BARK DRY	A, H
4546	SLIPPERY ELM BARK POWDER	A, E, H
4547	SMILAX ARISTOLOCHIIFOLIA	A, H
4548	SMILAX CHINA	A, H
4549	SMILAX GLABRA	A, H
4550	SMILAX OFFICINALIS	A, E, H
4551	SMILAX ORNATA	A, E, H
4552	SMOKE EXTRACT	E	Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
4553	SODIUM ACETATE	E
4554	SODIUM ACETYLATED HYALURONATE	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 1%.
4555	SODIUM ACID CITRATE	A, E, H	When sodium acid citrate is used as an active ingredient, only for use in oral medicines.
4556	SODIUM ACRYLATES COPOLYMER	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.8%.
4557	SODIUM ACRYLATES CROSSPOLYMER-2	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye or on damaged skin. The concentration in the medicine must be no more than 0.7 % (w/w).
4558	SODIUM ACRYLOYDIMETHYLTAURATE/VP CROSSPOLYMER	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye or on damaged skin. The concentration in the medicine must be no more than 2% (w/w).
4559	SODIUM ALGINATE	E
4560	SODIUM ASCORBATE	A, E, H
4561	SODIUM ASCORBYL PHOSPHATE	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. When used in a sunscreen, the concentration in the medicine must be no more than 0.1%. When used in products other than sunscreens, the concentration in the medicine must be no more than 0.5%.
4562	SODIUM ASCORBYL/CHOLESTERYL PHOSPHATE	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 5%.
4563	SODIUM BENZOATE	E
4564	SODIUM BETA-HYDROXY-BETA-METHYLBUTYRATE	A, H
4565	SODIUM BETA-HYDROXY-BETA-METHYLBUTYRATE MONOHYDRATE	A, H
4566	SODIUM BICARBONATE	A, E	When used as an active ingredient, the medicine may only be for oral rehydration salts in powdered and effervescent tablet dosage forms. Medicines containing sodium bicarbonate for use as oral rehydration therapy are subject to the following conditions: a) the medicine complies with the requirements specified in the British Pharmacopoeia, as in force or existing from time to time, for Oral Rehydration Salts; b) the sodium content and total osmolarity of the solution after it has been prepared according to the instructions on the packet are consistent with the criteria specified by the World Health Organisation (WHO) and the United Nations Childrens Fund (UNICEF) in the document 'Expert consultation on oral rehydration salts formulation 18 July 2001.' c) the following warning statements are required on the medicine label: - (UOAD) 'Use only as directed.' - (DIAR) 'If diarrhoea persists for more than 6 hours in infants under 6 months - 12 hours in children under 3 years - 24 hours in children aged 3-6 years or 48 hours in adults and children over 6 years - seek medical advice (or words to that effect).' - (DIAR3) 'If diarrhoea persists, seek medical advice.'
4567	SODIUM BISULFITE	E
4568	SODIUM BROMIDE	H	Only for use as an active homoeopathic ingredient. The total concentration of sodium bromide in the medicine must not be more than 10 mg/kg or 10 mg/L or 0.001%.
4569	SODIUM BUTYRATE	A, E	The route of administration for medicines that contain sodium butyrate must be limited to oral. The maximum recommended daily dose of the medicine must not provide more than 1200 mg sodium butyrate. The following warning statement (or words to the same effect) is required on the medicine label: - (ADULT) 'Adults only’.
4570	SODIUM C14-16 OLEFIN SULFONATE	E	Only for use in topical medicines for dermal application.
4571	SODIUM CALCIUM EDETATE	E	When for oral use, sodium is a mandatory component of sodium calcium edetate. Sodium calcium edetate must only be included in medicines when: (a) the route of administration is limited to topical for dermal use; or (b) in combination with other permitted ingredients as a flavour proprietary excipient formulation. The total concentration of sodium calcium edetate in the medicine must not exceed 0.32%. The total concentration of flavour proprietary excipient formulations containing sodium calcium edetate must not be more than 5% of the total medicine.
4572	SODIUM CARBOMER	E	Only for use as an excipient in topical medicines for dermal application.
4573	SODIUM CARBONATE	E	When used in a solid preparation, the pH of a 10 g/L aqueous solution must not be more than 11.5. When used in a liquid or a semi-solid preparation, the pH of the preparation must not exceed 11.5.
4574	SODIUM CARBONATE MONOHYDRATE	E	When used in a solid preparation, the pH of a 10 g/L aqueous solution must not be more than 11.5. When used in a liquid or a semi-solid preparation, the pH of the preparation must not exceed 11.5.
4575	SODIUM CARBOXYMETHYL BETAGLUCAN	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.005%.
4576	SODIUM CARRAGEENAN	E
4577	SODIUM CASEINATE	E	Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.
4578	SODIUM CETOSTEARYL SULFATE	E	Only for use in topical medicines for dermal application.
4579	SODIUM CHLORIDE	A, E, H
4580	SODIUM CHONDROITIN SULFATE	A, E	When used as an excipient ingredient: a) only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye; b) the concentration in the medicine must not be more than 0.001%. When used as an active ingredient: a) the route of administration must only be oral; b) the maximum daily dose must not provide more than 1,200 mg of sodium chondroitin sulfate; c) the following statements must be included on the medicine label: - (ADULT) ‘Adults only' (or words to that effect); - (PREGNT) ‘Not recommended for use by pregnant and lactating women’ (or words to that effect).
4581	SODIUM CITRATE	A, E	When for use as an active ingredient, only for oral use.
4582	SODIUM CITRATE DIHYDRATE	A, E	When for use as an active ingredient, only for oral use.
4583	SODIUM COCO PG-DIMONIUM CHLORIDE PHOSPHATE	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.05%.
4584	SODIUM COCOAMPHOACETATE	E	Only for use in topical medicines for dermal application.
4585	SODIUM COCOYL SARCOSINATE	E	Only for use in topical medicines for dermal application.
4586	SODIUM CYCLAMATE	E
4587	SODIUM DEHYDROACETATE	E	Only for use in topical medicines for dermal application.
4588	SODIUM DNA	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.1%.
4589	SODIUM DODECYLBENZENESULFONATE	E	Only for use in topical medicines for dermal application. The concentration in the medicine must be no more than 30%.
4590	SODIUM ERYTHORBATE	E
4591	SODIUM ETHYL HYDROXYBENZOATE	E
4592	SODIUM FLUORIDE	A, E, H	Fluoride is a mandatory component of sodium fluoride. The route of administration must be limited to dental. The dosage form must be limited to pastes, powders and/or gels for dental hygiene. When used as an active ingredient, the medicine is subject to the following conditions: (a) only for use in combination with at least one other active ingredient; and (b) the concentration of fluoride ion in the medicine must not be more than 1,500 mg/kg. When the concentration of fluoride ion is more than 1000 mg/kg, the medicine requires the following statements on the medicine label: - (DNTSW) 'Do not swallow.' - (CHILD4) 'Do not use [this product/insert name of product] in children 6 years of age or less.'
4593	SODIUM FUMARATE	E
4594	SODIUM HYALURONATE	A, E	When for use as an excipient ingredient, sodium hyaluronate must only be used in medicines with a topical route of administration for dermal application. When for use as an active ingredient: (a) the molecular mass of sodium hyaluronate must be between 600 and 1600 kilodaltons; and (b) sodium hyaluronate must only be used in medicines when the route of administration is limited to: (i) topical for dermal application; or (ii) oral. When for use in a topical medicine for dermal application the concentration of sodium hyaluronate in the medicine must not exceed 2.0%. When for use as an active ingredient and the route of administration is oral: (a) the maximum recommended daily dose must not provide more than 200 milligrams sodium hyaluronate; (b) the recommended duration of use of the medicine must be limited to three months; and (c) the following warning statements (or words to the same effect) are required on the medicine label: - (ADULT) 'Adults only’; and - (PREGNT) ' Not recommended for use by pregnant and lactating women'.
4595	SODIUM HYDROGENATED TALLOW GLUTAMATE	E	Only for use in topical medicines for dermal application.
4596	SODIUM HYDROXIDE	E	The concentration of sodium hydroxide in the medicine must not be more than 5%. When used in a solid preparation, the pH of a 10 g/L aqueous solution must not be more than 11.5. When used in a liquid or a semi-solid preparation, the pH of the preparation must not exceed 11.5.
4597	SODIUM HYDROXYCITRATE	A	The requirements specified below apply to a medicine that contains the ingredient that is: - listed in the Register on or after 1 March 2025; or - released for supply on or after 1 March 2026. When for oral use, the following warning statement is required on the medicine label: - (SHLIVER) ‘In very rare cases, sodium hydroxycitrate may harm the liver. Stop use and see a doctor if you have yellowing skin/eyes or unusual: fatigue, nausea, appetite loss, abdominal pain, dark urine, or itching.’ Medicines containing sodium hydroxycitrate must not be directed for use in children, or in pregnant or lactating women.
4598	SODIUM HYDROXYETHYL ACRYLATE/ACRYLOYLDIMETHYL TAURATE COPOLYMER	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 1.5%.
4599	SODIUM HYDROXYMETHYLGLYCINATE	E	Only for use in topical medicines for dermal application.
4600	SODIUM HYPOCHLORITE	E	The pH of the sodium hypochlorite preparation must be less than 11.5.
4601	SODIUM ISOSTEAROYL LACTYLATE	E	Only for use in topical medicines for dermal application.
4602	SODIUM LACTATE	E
4603	SODIUM LAURETH SULFATE	E
4604	SODIUM LAUROAMPHOACETATE	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 5%.
4605	SODIUM LAUROYL LACTYLATE	E	Sodium lauroyl lactylate must: (a) Only be used in topical medicines for dermal application; and (b) Not be included in medicines intended for use on broken skin or in the eye. The concentration in the medicine must be no more than 0.2%.
4606	SODIUM LAUROYL METHYL ISETHIONATE	E	Only for use in wash-off topical medicines for dermal application and not to be included in medicines intended for use in the eye or on damaged skin. The concentration in the medicine must be no more than 11%.
4607	SODIUM LAUROYL SARCOSINATE	E	Only for use in topical medicines for dermal application.
4608	SODIUM LAURYL PHOSPHATE	E
4609	SODIUM LAURYL SULFATE	E
4610	SODIUM LAURYL SULFOACETATE	E	Only for use in topical medicines for dermal application.
4611	SODIUM MAGNESIUM SILICATE	E	Only for use in topical medicines for dermal application.
4612	SODIUM MANNOSE PHOSPHATE	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.5%.
4613	SODIUM METABISULFITE	E
4614	SODIUM METAPHOSPHATE	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye or damaged skin. The concentration in the medicine must not be more than 0.1%.
4615	SODIUM METHYL COCOYL TAURATE	E	Only for dental use. The concentration in the medicine must be no more than 2%.
4616	SODIUM METHYL HYDROXYBENZOATE	E
4617	SODIUM MOLYBDATE DIHYDRATE	A	Only for use in oral medicines. Molybdenum is a mandatory component of Sodium molybdate dihydrate. The percentage of molybdenum from sodium molybdate dihydrate should be calculated based on the molecular weight of sodium molybdate dihydrate. The maximum daily dose of molybdenum from Sodium molybdate dihydrate must be no more than 125 micrograms.
4618	SODIUM MONOFLUOROPHOSPHATE	A	Fluoride is a mandatory component of sodium monofluorophosphate. The route of administration must be limited to dental. The dosage form must be limited to pastes, powders and/or gels for dental hygiene. When sodium monofluorophosphate is used as an active ingredient, it is subject to the following conditions: (a) only for use in combination with at least one other active ingredient; and (b) the concentration of fluoride ion in the medicine must not be more than 1,500 mg/kg. When the concentration of fluoride ion is more than 1000 mg/kg, the following warning statements are required on the medicine label: - (DNTSW) 'Do not swallow.' - (CHILD4) 'Do not use [this product/insert name of product] in children 6 years of age or less.'
4619	SODIUM MYRISTOYL GLUTAMATE	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.0164%.
4620	SODIUM NITRATE	H	Only for use as an active homoeopathic ingredient.
4621	SODIUM NONOXYNOL-4 SULFATE	E	Only for use in topical medicines for dermal application.
4622	SODIUM PANTOTHENATE	A, E, H
4623	SODIUM PCA	E	Only for use in topical medicines for dermal application.
4624	SODIUM PERBORATE	A, H	Boron is a mandatory component of sodium perborate. When for internal use, the maximum recommended daily dose must not provide more than 6 mg of boron. When used in preparations for dermal use, which are not for paediatric or antifungal use, the concentration of boron from all ingredients in the product must not exceed 3500 mg/kg or 3500 mg/L or 0.35%. When the maximum recommended daily dose of the medicine provides more than 3 mg of boron and the medicine is for internal use and/or oral application, one of the following warning statements is required on the label: - (NTAKEN12) 'Not to be taken by children under 12 years old' (or words to that effect); or - (ADULT) 'Adults only' (or words to that effect). When the maximum recommended daily dose of the medicine provides more than 1 mg boron and up to, and including, 3 mg of boron, and the medicine is for internal use and/or oral application, one of the following warning statements is required on the label: - (NTAKEN2) 'Not to be taken by children under 2 years old' (or words to that effect); or - (ADULT) 'Adults only' (or words to that effect). When for excipient use and the maximum recommended daily dose of the medicine provides more than 1 mg of boron and the medicine is for internal use and/or oral application, the following warning statement is required on the label: - (BORON) 'Contains boron' (or words to that effect). When the medicine is for topical use for dermal application, the following warning statement is required on the label: - (BROKEN) 'Use on unbroken skin only' (or words to that effect).
4625	SODIUM PERCARBONATE	E	Only for use in topical medicines for dermal application. The concentration in the medicine must be no more than 15%.
4626	SODIUM POLYACRYLATE	E	Only for use in topical medicines for dermal application.
4627	SODIUM POLYACRYLATE STARCH	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must not be more than 1%.
4628	SODIUM POLYMETAPHOSPHATE	E
4629	SODIUM PROPIONATE	E
4630	SODIUM PROPYL HYDROXYBENZOATE	E
4631	SODIUM RNA	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.2%.
4632	SODIUM SELENATE	A, H	Selenium is a mandatory component of sodium selenate. Oral medicines must contain no more than 150 micrograms of selenium per maximum recommended daily dose. When for oral use, the medicine requires the following warning statement on the medicine label: - (SELE) 'This medicine contains selenium which is toxic in high doses. A daily dose of 150 micrograms for adults of selenium from dietary supplements should not be exceeded.'
4633	SODIUM SELENATE DECAHYDRATE	A	Selenium is a mandatory component of sodium selenate decahydrate. Oral medicines must contain no more than 150 micrograms of selenium per maximum recommended daily dose. When for oral use, the medicine requires the following warning statement on the medicine label: - (SELE) 'This medicine contains selenium which is toxic in high doses. A daily dose of 150 micrograms for adults of selenium from dietary supplements should not be exceeded.'
4634	SODIUM SELENITE	A, H	Selenium is a mandatory component of Sodium selenite. Oral medicines must contain no more than 150 micrograms of selenium per maximum recommended daily dose. When for oral use, the medicine requires the following warning statement on the medicine label: - (SELE) 'This medicine contains selenium which is toxic in high doses. A daily dose of 150 micrograms for adults of selenium from dietary supplements should not be exceeded.’
4635	SODIUM SELENITE PENTAHYDRATE	A	Selenium is a mandatory component of Sodium selenite pentahydrate. Oral medicines must contain no more than 150 micrograms of selenium per maximum recommended daily dose. When for oral use, the medicine requires the following warning statement on the medicine label: - (SELE) 'This medicine contains selenium which is toxic in high doses. A daily dose of 150 micrograms for adults of selenium from dietary supplements should not be exceeded.’
4636	SODIUM SILICATE	E
4637	SODIUM STARCH GLYCOLLATE	E
4638	SODIUM STARCH GLYCOLLATE TYPE A	E
4639	SODIUM STEARATE	E	Only for use in topical medicines for dermal application.
4640	SODIUM STEAROXY PG-HYDROXYETHYLCELLULOSE SULFONATE	E	Only for use in topical medicines for dermal application and not to be used in topical medicines intended for use in the eye. The concentration in the medicine must be no more than 2%.
4641	SODIUM STEAROYL GLUTAMATE	E	Only for use in topical medicines for dermal application and not to be used in topical medicines intended for use in the eye. The concentration in the medicine must be no more than 2.5%.
4642	SODIUM STEAROYL LACTYLATE	E	Only for use in topical medicines for dermal application.
4643	SODIUM STEARYL PHTHALAMATE	E	Only for use in medicines for dermal application and not to be used in topical medicines intended for use in the eye. The concentration in the medicine must be no more than 1.5%.
4644	SODIUM SUCCINATE	E	Only for use in topical medicines for dermal application.
4645	SODIUM SULFATE	A, E, H	When it is not intended to be a laxative, the following warning statement is required on the medicine label: - (LAX4) 'Substance may have a laxative effect'.
4646	SODIUM SULFATE DECAHYDRATE	A, E, H	When it is not intended to be a laxative, the following warning statement is required on the medicine label: - (LAX4) 'Substance may have a laxative effect'.
4647	SODIUM SULFITE	E
4648	SODIUM SULFITE HEPTAHYDRATE	E	Only for use in topical medicines for dermal application.
4649	SODIUM TRIPOLYPHOSPHATE	E	Only for use when the route of administration is topical for dermal application, mucous membrane (buccal mucosa) or dental. Not to be included in topical medicines intended for use in the eye. The concentration in the medicine must be no more than 5%.
4650	SOLANUM DULCAMARA	A, H	When for internal use, steroidal alkaloids calculated as solanine is a mandatory component of Solanum dulcamara. When for internal use, the maximum recommended daily dose must not provide more than 10mg of steroidal alkaloids calculated as solanine.
4651	SOLANUM FEROX	A, H	When for internal use, steroidal alkaloids calculated as solanine is a mandatory component of Solanum ferox. When for internal use, the maximum recommended daily dose must not provide more than 10mg of steroidal alkaloids calculated as solanine.
4652	SOLANUM LYCOCARPUM FRUIT EXTRACT	E	Only for use in topical medicines for dermal use and not to be included in topical medicines intended for use in the eye. The concentration in the medicine must be no more than 0.02%.
4653	SOLANUM MELONGENA	A, H	When for internal use, steroidal alkaloids calculated as solanine is a mandatory component of Solanum melongena. When for internal use, the maximum recommended daily dose must not provide more than 10mg of steroidal alkaloids calculated as solanine.
4654	SOLANUM NIGRUM	A, H	When for internal use, steroidal alkaloids calculated as solanine is a mandatory component of Solanum nigrum. When for internal use, the maximum recommended daily dose must not provide more than 10mg of steroidal alkaloids calculated as solanine.
4655	SOLANUM TUBEROSUM	A, H	When for internal use, steroidal alkaloids calculated as solanine is a mandatory component of Solanum tuberosum. When for internal use, the maximum recommended daily dose must not provide more than 10mg of steroidal alkaloids calculated as solanine.
4656	SOLIDAGO GIGANTEA	A, H
4657	SOLIDAGO GIGANTEA MIS	A, E, H
4658	SOLIDAGO VIRGAUREA	A, E, H
4659	SOLUBLE MAIZE STARCH	E
4660	SOLUBLE POTATO STARCH	E
4661	SOLVENT GREEN 3	E	Permitted for use only as a colour for topical use.
4662	SOLVENT RED 1	E	Permitted for use only as a colour for topical use.
4663	SOLVENT VIOLET 13	E	Permitted for use only as a colour for topical use.
4664	SOLVENT YELLOW 172	E	Permitted for use only as a colour for topical use. The concentration in the medicine must be no more than 0.3%.
4665	SOLVENT YELLOW 33	E	Permitted for use only as a colour for topical use.
4666	SOPHORA FLAVESCENS	A, E, H
4667	SOPHORA TONKINENSIS	A, H
4668	SORBIC ACID	E
4669	SORBITAN DISTEARATE	E	Until 10 December 2027, Sorbitan distearate must only be used in a medicine where:(a) Kao Australia Pty Ltd is the sponsor of the medicine (the primary sponsor); or (b) another person is the sponsor of the medicine (the secondary sponsor) and the TGA has been notified that the secondary sponsor has been authorised by the primary sponsor to use the ingredient in the medicine. Sorbitan distearate must (c) only be use in topical medicines for dermal application; and (d) not be included in medicines intended for use on broken skin The total concentration of sorbitan distearate in the medicine must not be more than 0.15%.
4670	SORBITAN ISOSTEARATE	E	Only for use in topical medicines for dermal application.
4671	SORBITAN MONO-OLEATE	E
4672	SORBITAN MONOLAURATE	E
4673	SORBITAN MONOSTEARATE	E
4674	SORBITAN OLEATE	E
4675	SORBITAN OLIVATE	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 10%.
4676	SORBITAN PALMITATE	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye or on damaged skin. The concentration in the medicine must be no more than 2%.
4677	SORBITAN SESQUIISOSTEARATE	E	Only for use in topical medicines for dermal application.
4678	SORBITAN SESQUIOLEATE	E	Only for use in topical medicines for dermal application.
4679	SORBITAN STEARATE	E
4680	SORBITAN TRISTEARATE	E	Only for use in topical medicines for dermal application.
4681	SORBITOL	A, E	When used as an active ingredient, can only be supplied as an uncompounded medicine substance packed for retail sale, and must comply with an uncompounded substance monograph of the British Pharmacopoeia, as in force or existing from time to time.
4682	SORBITOL SOLUTION (70 PER CENT) (CRYSTALLISING)	A, E	Sorbitol is a mandatory component of sorbitol solution (70 per cent) (crystallising). When used as an active ingredient, can only be supplied as an uncompounded medicine substance packed for retail sale, and must comply with an uncompounded substance monograph of the British Pharmacopoeia, as in force or existing from time to time.
4683	SORBITOL SOLUTION (70 PER CENT) (NON-CRYSTALLISING)	A, E	Sorbitol is a mandatory component of sorbitol solution (70 per cent) (non-crystallising). When used as an active ingredient, can only be supplied as an uncompounded medicine substance packed for retail sale, and must comply with an uncompounded substance monograph of the British Pharmacopoeia, as in force or existing from time to time.
4684	SORBUS AUCUPARIA	A, H
4685	SORGHUM	E
4686	SORGHUM VULGARE	A, H
4687	SOY PHOSPHATIDYLSERINE-ENRICHED SOY LECITHIN LIQUID	A	Soy phosphatidylserine is a mandatory component of soy phosphatidylserine-enriched soy lecithin liquid. The maximum recommended daily dose of the medicine must not provide more than 300 mg of soy phosphatidylserine.
4688	SOY PHOSPHATIDYLSERINE-ENRICHED SOY LECITHIN POWDER	A	Soy phosphatidylserine is a mandatory component of soy phosphatidylserine-enriched soy lecithin powder. The maximum recommended daily dose of the medicine must not provide more than 300 mg of soy phosphatidylserine.
4689	SOY POLYSACCHARIDE	E
4690	SOY PROTEIN	E
4691	SOY STEROL	E
4692	SOYA BEAN	E
4693	SOYA OIL	A, E, H
4694	SOYBEAN FLOUR	E	Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
4695	SOYBEAN GLYCERIDES	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 4%.
4696	SPARGANIUM STOLONIFERUM	A, H
4697	SPARTIUM JUNCEUM	A, H
4698	SPATHOLOBUS SUBERECTUS	A, H
4699	SPEARMINT OIL	A, E, H	Menthol is a mandatory component of spearmint oil. When the medicine is for topical use for dermal application: (i) the medicine must not be intended for use in the eye or on damaged skin; (ii) the medicine must not deliver more than 25% total menthol when administered according to the directions for use; (iii) the following warning statement is required on the medicine label: - (EYE) Avoid contact with eyes (or words to that effect). (iv) if the medicine delivers more than 1% total menthol when administered according to the directions for use, the following warning statements are required on the medicine label: - (SKTEST) If you have sensitive skin, test this product on a small area of skin before applying it to a large area; - (IRRIT) If irritation develops, discontinue use. (v) if the medicine delivers more than 5% total menthol when administered according to the directions for use, the following warning statement is required on the medicine label: – (MENTH) Contains a high concentration of menthol, which can cause severe skin irritation. When the medicine is for internal use, the maximum recommended daily dose must not contain more than 1 gram of menthol.
4700	SPEARMINT OIL TERPENELESS	E	Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. Menthol is a mandatory component of spearmint oil terpeneless. When the medicine is for topical use for dermal application: i) the medicine must not be intended for use in the eye or on damaged skin; ii) the medicine must not deliver more than 25% total menthol when administered according to the directions for use; iii) the following warning statement is required on the medicine label: - (EYE) Avoid contact with eyes (or words to that effect). iv) if the medicine delivers more than 1% total menthol when administered according to the directions for use, the following warning statements are required on the medicine label: - (SKTEST) If you have sensitive skin, test this product on a small area of skin before applying it to a large area; - (IRRIT) If irritation develops, discontinue use. v) if the medicine delivers more than 5% total menthol when administered according to the directions for use, the following warning statement is required on the medicine label: – (MENTH) Contains a high concentration of menthol, which can cause severe skin irritation. When the medicine is for internal use, the maximum recommended daily dose must not contain more than 1 gram of menthol.
4701	SPHINGOLIPIDS	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.1%.
4702	SPIGELIA ANTHELMIA	A, H
4703	SPIGELIA MARILANDICA	A, H	The maximum recommended daily dose must be no more than the equivalent of 1mg of the dry herbal material.
4704	SPIKE LAVENDER OIL	A, E, H	Camphor is a mandatory component of spike lavender oil. In solid and semi solid preparations, the concentration of camphor must be no more than 12.5%. In liquid preparations other than essential oils, the concentration of camphor must be no more than 2.5%. In essential oil preparations, if the concentration of camphor is more than 2.5% but less than or equal to 10%, and the nominal capacity of the container is less than 25 millilitres, the medicine must have a restricted flow insert fitted on the container and include the following warning statements on the medicine label: - (CHILD) 'Keep out of reach of children' (or words to that effect); and - (NTAKEN) 'Not to be taken'. In essential oil preparations, if the concentration of camphor is more than 10%, and the nominal capacity of the container is less than 15 millilitres, the medicine must have a restricted flow insert fitted on the container and include the following warning statements on the medicine label: - (CHILD) 'Keep out of reach of children' (or words to that effect); and - (NTAKEN) 'Not to be taken'. In essential oil preparations, if the concentration of camphor is more than 10%, and the nominal capacity of the container is more than 15 millilitres but less than or equal to 25 millilitres, the medicine must have a restricted flow insert and child resistant closure fitted on the container and include the following warning statements on the medicine label: - (CHILD) 'Keep out of reach of children' (or words to that effect); and - (NTAKEN) 'Not to be taken'. If the concentration of camphor is more than 2.5%, the nominal capacity of the container must be no more than 25 millilitres.
4705	SPINACH	E
4706	SPINACIA OLERACEA	A, E, H
4707	SPIRODELA POLYRRHIZA	A, H
4708	SPIRULINA	E
4709	SPRAY-DRIED GLUCOSE SYRUP	E	Permitted for use as an excipient for oral routes of administration.
4710	SPRAY-DRIED LIQUID GLUCOSE	E	Permitted for use as an excipient for oral routes of administration.
4711	SPRUCE OIL	E	Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
4712	SQUALANE	E	Only for use in topical medicines for dermal application.
4713	SQUALENE	A, E
4714	SQUID OIL	A	Only for use in oral medicines. Must be obtained from species of the order Teuthida of the class Cephalopoda, be used in combination with other ingredients in the medicine and be presented in a therapeutic dosage form for therapeutic use. The following warning statement is required on the medicine label: - (MOLLUSC) ‘Contains mollusc’ or ’Contains mollusc products’.
4715	SQUILL DRY	A, H
4716	SQUILL INDIAN DRY	A, H
4717	SQUILL INDIAN POWDER	A, H
4718	SQUILL POWDER	A, H
4719	ST JOHN'S WORT DRY EXTRACT QUANTIFIED	A	When used for oral ingestion, the medicine requires the following warning statement on the medicine label: - (STJOHN) 'St John's Wort affects the way many prescription medicines work - including oral contraceptives. Consult your doctor.'
4720	ST JOHN'S WORT HERB DRY	A, H	When used for oral ingestion, the medicine requires the following warning statement on the medicine label: - (STJOHN) 'St John's Wort affects the way many prescription medicines work - including oral contraceptives. Consult your doctor.'
4721	ST JOHN'S WORT HERB POWDER	A, H	When used for oral ingestion, the medicine requires the following warning statement on the medicine label: - (STJOHN) 'St John's Wort affects the way many prescription medicines work - including oral contraceptives. Consult your doctor.'
4722	STACHYS OFFICINALIS	A, E, H
4723	STACHYS PALUSTRIS	A, H
4724	STACHYURUS HIMALAICUS	A, H
4725	STANNIC OXIDE	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.005%.
4726	STANNOUS CHLORIDE	H	Only for use as an active homoeopathic ingredient.
4727	STAR ANISE OIL	A, E	When the total concentration of star anise oil in the medicine is more than 50%: (a) the nominal capacity of the container must not be more than 50 mL; (b) a restricted flow insert must be fitted on the container; and (c) the following warning statement is required on the medicine label: - (CHILD) ‘Keep out of reach of children’ (or words to that effect).
4728	STARCH	E	Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
4729	STARCH SODIUM OCTENYL SUCCINATE	E
4730	STEARALKONIUM CHLORIDE	E	Only for use in topical medicines for dermal application.
4731	STEARALKONIUM HECTORITE	E	Only for use in topical medicines for dermal application.
4732	STEARAMIDE	E	Only for use in topical medicines for dermal application.
4733	STEARAMIDOETHYL DIETHYLAMINE	E	Only for use in topical medicines for dermal application.
4734	STEARAMIDOPROPYL DIMETHYLAMINE	E	Only for use in topical medicines for dermal application.
4735	STEARAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE	E	Only for use in topical medicines for dermal application. The concentration in the medicine must be no more than 2%. When the medicine is intended to be used on the eye, the medicine requires the following warning statement on the medicine label: - (EYE2) 'May be irritant to the eyes' (or words to that effect).
4736	STEARETH-10	E	Only for use in topical medicines for dermal application.
4737	STEARETH-100	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 1.5%.
4738	STEARETH-2	E	Only for use in topical medicines for dermal application.
4739	STEARETH-20	E	Only for use in topical medicines for dermal application.
4740	STEARETH-21	E	Only for use in topical medicines for dermal application.
4741	STEARETH-5	E	Only for use in topical medicines for dermal application.
4742	STEARIC ACID	E
4743	STEAROPTENES	E	Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.
4744	STEAROXY DIMETHICONE	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 4%.
4745	STEAROXYTRIMETHYLSILANE	E	Only for use in topical medicines for dermal application.
4746	STEAROYL GLUTAMIC ACID	E	Until 10 December 2027, Stearoyl glutamic acid must only be used in a medicine where: (a) Kao Australia Pty Ltd is the sponsor of the medicine (the primary sponsor); or (b) another person is the sponsor of the medicine (the secondary sponsor) and the TGA has been notified that the secondary sponsor has been authorised by the primary sponsor to use the ingredient in the medicine. Stearoyl glutamic acid must (a) only be use in topical medicines for dermal application; and (b) not be included in medicines intended for use on broken skin The following warning statement (or words to the same effect) is required on the medicine label: (a) - (EYE) ‘Avoid contact with eyes' The total concentration of stearoyl glutamic acid in the medicine must not be more than 0.058%.
4747	STEAROYL MACROGOLGLYCERIDES	E	Only for use in oral medicines. The concentration in the medicine must be no more than 0.6%.
4748	STEARYL ACETATE	E	Only for use in topical medicines for dermal application.
4749	STEARYL ALCOHOL	E
4750	STEARYL BEHENATE	E	Only for use as an excipient ingredient for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must not be more than 3.5% in the final formulation.
4751	STEARYL DIMETHICONE	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 4.5%. The medicine requires the following warning statements on the medicine label: - (EYE2) 'May be irritant to the eyes' (or words to that effect) - (EYE) 'Avoid contact with eyes' (or words to that effect).
4752	STEARYL GLYCYRRHETINATE	E	Only for use in topical medicines for dermal application.
4753	STEARYL HEPTANOATE	E	Only for use in topical medicines for dermal application.
4754	STEARYL MYRISTATE	E	Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.
4755	STEARYL STEARATE	E	Only for use in topical medicines for dermal application.
4756	STELLARIA CHAMAEJASME	A, H
4757	STELLARIA DICHOTOMA	A, H
4758	STELLARIA MEDIA	A, E, H
4759	STEMONA JAPONICA	A, H
4760	STEMONA SESSILIFOLIA	A, H
4761	STENOTAPHRUM SECUNDATUM	A, H
4762	STEPHANIA TETRANDA	A, H
4763	STERCULIA	A, H
4764	STERCULIA TRAGACANTHA	A, H
4765	STERCULIA URENS	A, H
4766	STEVIA REBAUDIANA	A, E, H
4767	STEVIOL GLYCOSIDES	E	Only for use in oral medicines.
4768	STILLINGIA SYLVATICA	A, H
4769	STORAX PREPARED	A, E, H
4770	STRAWBERRY	E
4771	STRAWBERRY ESSENCE	E	Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
4772	STREPTOCOCCUS SALIVARIUS	A	Only permitted for use in medicines: - that are for oral routes of administration; and - when the strain of Streptococcus salivarius is confirmed to be K12 or M18. The name of the Streptococcus salivarius strain must be declared on the label. The following warning statement is required on the medicine label: - (CHILD5) 'Use in children under 3 years is not recommended'.
4773	STREPTOCOCCUS THERMOPHILUS	A
4774	STROBILANTHES CUSIA	A, H
4775	STRONG AMMONIA SOLUTION	E	Ammonia is a mandatory component of strong ammonia solution. The concentration of ammonia in the medicine must be no more than 0.5%. When for internal use, the concentration in the medicine must be no more than 0.25%.
4776	STRONTIUM CARBONATE	H	Only for use as an active homoeopathic ingredient.
4777	STROPHANTHUS GRATUS	H	Only for use as an active homoeopathic ingredient.
4778	STROPHANTHUS HISPIDUS	H	Only for use as an active homoeopathic ingredient.
4779	STRYCHNOS IGNATII	H	Only for use as an active homoeopathic ingredient. Strychnine (of Strychnos spp.) is a mandatory component of Strychnos ignatii. The concentration of Strychnine (of Strychnos spp.) must not be more than 1 milligram/Kg or 1 milligram/L or 0.0001%.
4780	STRYCHNOS NUX-VOMICA	A, H	Strychnine (of Strychnos spp.) is a mandatory component of Strychnos nux-vomica. The concentration of Strychnine (of Strychnos spp.) must not be more than 1 milligram/Kg or 1 milligram/L or 0.0001%.
4781	STYPHNOLOBIUM JAPONICUM	A, E, H
4782	STYRALLYL PROPIONATE	E	Only for use in medicines in combination with other permitted ingredients as a fragrance proprietary excipient formulation. The total fragrance proprietary excipient formulation in a medicine must not be more than 1%.
4783	STYRAX BENZOIN	A, E, H
4784	STYRAX OIL	E	Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.
4785	STYRAX PARALLELONEURUM	A, H
4786	STYRAX TONKINENSIS	A, H
4787	STYRENE	E	Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. The total concentration of styrene in the medicine must not be more than 10 mg/kg or 10 mg/L or 0.001%.
4788	STYRENE/ACRYLATES COPOLYMER	E	Only for use in topical medicines for dermal application.
4789	STYROLYL ACETATE	E	Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.
4790	SUBLIMED SULFUR	H	Only for use as an active homoeopathic ingredient.
4791	SUCCINIC ACID	E
4792	SUCRALOSE	E
4793	SUCROSE	E
4794	SUCROSE ACETATE ISOBUTYRATE	E	Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
4795	SUCROSE ACETATE PALMITATE STEARATE	E	Only for use in topical medicines for dermal application and not intended for use in the eye or on damaged skin. The concentration in the medicine must be no more than 0.3%.
4796	SUCROSE COCOATE	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 2%.
4797	SUCROSE DISTEARATE	E	Only for use in topical medicines for dermal application.
4798	SUCROSE LAURATE	E	When for oral or sublingual use, sucrose is a mandatory component of sucrose laurate.
4799	SUCROSE OCTAACETATE	E	When for oral or sublingual use, sucrose is a mandatory component of sucrose octaacetate.
4800	SUCROSE PALMITATE	E	Only for use in topical medicines for dermal application.
4801	SUCROSE POLYCOTTONSEEDATE	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 1%. The medicine requires the following warning statements on the medicine label: - (EYE) 'Avoid contact with the eyes' (or words to that effect) - (EYE2) 'May be irritant to the eyes' (or words to that effect).
4802	SUCROSE STEARATE	E	For use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. When for topical use, the concentration in the medicine must be no more than 0.25%. For oral use as a manufacturing aid only. When for oral use, the concentration in the medicine must be no more than 0.2 mg per dosage unit.
4803	SUCROSE TRISTEARATE	E	Only for use in topical medicines for dermal application and not to be included in medicines for use in the eye or on damaged skin. The concentration in the medicine must be no more than 2%.
4804	SUDAN III	E	Permitted for use only as a colour for topical use.
4805	SUGAR CANE WAX ALCOHOLS	A, H	The routes of administration for medicines that contain sugar cane wax alcohols must be limited to: (a) topical for dermal use; and (b) oral. When for use in topical medicines, the maximum recommended daily dose of the medicine must not provide more than 12 mg of sugar cane wax alcohols. When for oral use: (a) the maximum recommended daily dose of the medicine must not provide more than: (i) 12 mg of sugar cane wax alcohols for individuals aged less than 18 years; and (ii) 20 mg of sugar cane wax alcohols for individuals aged 18 years and above. (b) The following warning statement (or words to the same effect) is required on the medicine label: - (PREGNT) 'Not recommended for use by pregnant and lactating women'. (c) If the maximum recommended daily dose of the medicine contains 20 mg of sugar cane wax alcohols, the following warning statement is also required on the medicine label: - (ADULTS) ‘Adults only’.
4806	SUGARCANE	E, H	When for oral or sublingual use, sucrose is a mandatory component of sugarcane.
4807	SULFATED CASTOR OIL	E	Only for use in topical medicines for dermal application.
4808	SULFATED LOW MOLECULAR WEIGHT FUCANS	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.025%.
4809	SULFUR DIOXIDE	E
4810	SULFUR IODIDE	H	Only for use as an active homoeopathic ingredient.
4811	SULFURIC ACID	E, H	Only for use as an active homoeopathic ingredient or excipient ingredient. The concentration in the medicine must be no more than 0.5%.
4812	SULFURISED 1-METHYL-4-(1-METHYLETHENYL)-CYCLOHEXENE	E	Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.
4813	SULISOBENZONE	A	Only for use as an active ingredient in sunscreens for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must not be more than 10%. When used in primary sunscreen products, the following warning statements are required on the label: - (AVOID) 'Avoid prolonged exposure in the sun' (or words to this effect); and - (SUNPRO) 'Wear protective clothing - hats and eyewear when exposed to the sun' (or words to this effect).
4814	SULISOBENZONE SODIUM	A	Only for use as an active ingredient in sunscreens for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must not be more than 10%. When used in primary sunscreen products, the following warning statements are required on the label: - (AVOID) 'Avoid prolonged exposure in the sun' (or words to this effect); and - (SUNPRO) 'Wear protective clothing - hats and eyewear when exposed to the sun' (or words to this effect).
4815	SUNFLOWER OIL	A, E, H
4816	SUNFLOWER SEED	E, H
4817	SUNSET YELLOW FCF	E	Permitted for use only as a colour for either topical use or with an oral route of administration.
4818	SUNSET YELLOW FCF ALUMINIUM LAKE	E	Permitted for use only as a colour in medicines limited to topical and oral routes of administration.
4819	SUPEROXIDE DISMUTASE	E	Only for use in topical medicines for dermal application.
4820	SWEDE	E
4821	SWEET ORANGE OIL TERPENES AND TERPENOIDS	E	Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.
4822	SWEET POTATO	E
4823	SWERTIA CHIRATA	A, H
4824	SWIETENIA MAHOGANI	A, H
4825	SYAGRUS ROMANZOFFIANA	A, E, H
4826	SYMPHYOTRICHUM NOVI-BELGII	A, H
4827	SYMPHYTUM OFFICINALE	H	When used orally as an active homoeopathic ingredient, the concentration must be a dilution of 12X or more. When used in topical medicines for dermal application, the concentration in the preparation must be no more than 10mg/kg or 10mg/L or 0.001%.
4828	SYMPLOCARPUS FOETIDUS	A, H
4829	SYNTHETIC BEESWAX	E	Only for use in topical medicines for dermal applications.
4830	SYNTHETIC TERPENE RESIN	E	Only for use in topical, oral or oral application medicines. When the route of administration is oral, the dosage form must be chewing gum.
4831	SYNTHETIC WAX	E
4832	SYRINGA RETICULATA	A, H
4833	SYRINGA VULGARIS	A, H
4834	SYZYGIUM AROMATICUM	A, E, H	When the plant preparation is oil or distillate and the concentration of this oil or distillate in the product is greater than 25%, the nominal capacity of the container must be no more than 25 millilitres and the medicine must include the following warning statements on the medicine label: - (CHILD) 'Keep out of reach of children' (or words to that effect); and - (NTAKEN) 'Not to be taken'. When the plant preparation is oil or distillate, the concentration of this oil or distillate in the medicine is greater than 25% and the nominal capacity of the container is more than 15 millilitres but less than or equal to 25 millilitres, a child resistant closure and restricted flow insert must be fitted on the container. When the plant preparation is oil or distillate, the concentration of oil or distillate in the product is greater than 25% and the nominal capacity of the container is less than 15 millilitres, a restricted flow insert must be fitted on the container. When the plant preparation is oil or distillate and the preparation is for topical use in the mouth, the preparation may not contain more than 5 millilitres of the oil or distillate and the concentration of oil or distillate in the product must not be greater than 25%.
4835	SYZYGIUM CUMINI	A, H
4836	SYZYGIUM JAMBOS	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must not be more than 0.0693%.
4837	TABEBUIA SERRATIFOLIA	A, E, H
4838	TADEHAGI TRIQUETRUM	A, H
4839	TAGETES ERECTA	A, E, H	When used as an excipient ingredient, only for use in combination with other permitted ingredients as a flavour proprietary excipient formulation. The total flavour proprietary excipient formulation in a medicine must not be more than 5%.
4840	TAGETES MINUTA	A, E, H
4841	TAGETES OIL	E	Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.
4842	TAIPAN SNAKE	H	Only for use as an active homoeopathic ingredient.
4843	TALLOW	E	Only for use in topical medicines for dermal application.
4844	TALLOW GLYCERIDES	E
4845	TAMARINDUS INDICA	E	Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.
4846	TAMARIX APHYLLA	A, H
4847	TAMARIX CHINENSIS	A, H
4848	TAMARIX GALLICA	A, H
4849	TAMUS COMMUNIS	A, H	If the plant part is fruit or root, the maximum recommended daily dose must be no more than 1mg of the equivalent dry fruit or dry root of Tamus communis.
4850	TANACETUM CINERARIIFOLIUM	A, H	The concentration in the medicine must be no more than 10%.
4851	TANACETUM COCCINEUM SUBSP. COCCINEUM	A, H
4852	TANACETUM PARTHENIUM	A, E, H
4853	TANACETUM VULGARE	A, H	Oil (of Tanacetum vulgare) is a mandatory component of Tanacetum vulgare. The concentration of oil (of Tanacetum vulgare) in the medicine must be no more than 0.8%.
4854	TANGERINE OIL	E	Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.
4855	TANGERINE OIL COLDPRESSED	A, E, H	When used internally, oxedrine is a mandatory component of tangerine oil coldpressed. The quantity of oxedrine in the maximum recommended daily dose must be no more than 30 milligrams.
4856	TANNIC ACID	E
4857	TAPIOCA STARCH	E
4858	TARAXACUM MONGOLICUM	A, E, H
4859	TARAXACUM OFFICINALE	A, E, H
4860	TARO	E
4861	TARRAGON OIL	A, E, H
4862	TARTARIC ACID	E
4863	TARTRAZINE	E	Only for use as a colour. Only for use in medicines for topical and oral administration.
4864	TARTRAZINE ALUMINIUM LAKE	E	Only for use as a colour. Only for use in medicines for topical and oral administration.
4865	TASMANNIA LANCEOLATA	E	Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
4866	TAURINE	A, E
4867	TEA-STEARATE	E	Only for use in topical medicines for dermal application.
4868	TERMINALIA ARJUNA	A	Only for use in oral medicines. Only for use when the plant part is bark. The maximum recommended daily dose must be no more than 6 grams of Terminalia arjuna dried bark or its extract equivalents. The medicine requires the following warning statements on the medicine label: - (PREGNT) 'Not recommended for use by pregnant and lactating women' (or words to that effect) - (CHILD2) 'Not suitable for children'.
4869	TERMINALIA BELLIRICA	A	Only for use when the preparation is as an aqueous extract of the fruit pericarp.
4870	TERMINALIA CATAPPA	A, H
4871	TERMINALIA CHEBULA	A, H
4872	TERMINALIA FERDINANDIANA	A, E, H	When used as an active ingredient: (a) the plant part must be from fruit flesh or seed only; and (b) the plant preparation must be limited to fresh, dry, powder. and extraction preparations with water as the only solvent. When used as an excipient ingredient: (a) the route of administration for medicines that contain Terminalia ferdinandiana must be limited to topical for dermal use; (b) medicines that contain Terminalia ferdinandiana are not to be intended for use on damaged skin or in the eye; and (c) the concentration of Terminalia ferdinandiana in the medicine must not be more than 0.3%.
4873	TERMINALIA SERICEA	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. Only for use when the plant part is root bark. Only methanol/water (90:10; V/V) extract of Terminalia sericea bark of the root is approved. The concentration in the medicine must be no more than 0.1%.
4874	TERPENE RESIN	E	Terpene resin must only be included in medicines when in combination with other permitted ingredients as a proprietary excipient formulation in medicines with a dermal route of administration for topical application.
4875	TERPINEN-4-OL	E	Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.
4876	TERPINEOL	E
4877	TERPINEOL ACETATE	E	Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.
4878	TERPINOLENE	E	Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.
4879	TERPINYL ACETATE	E	Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.
4880	TERPINYL BUTYRATE	E	Permitted for use only in combination with other permitted ingredients as a flavour. If used as a flavour the total flavour concentration in a medicine must be no more than 5%.
4881	TERPINYL METHYL ETHER	E	Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.
4882	TERT-BUTYL ALCOHOL	E	Only for use in topical medicines for dermal application.
4883	TERT-BUTYL HYDROQUINONE	E	Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.
4884	TERT-BUTYL METHYL ETHER	E	Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
4885	TERT-BUTYLPYRAZINE	E	Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.
4886	TETRACLINIS ARTICULATA	A, E, H
4887	TETRADECYL AMINOBUTYROYLVALYLAMINOBUTYRIC UREA TRIFLUOROACETATE	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye or on damaged skin. The concentration in the medicine must be no more than 0.002%.
4888	TETRADIUM RUTICARPUM	A, H	When for internal use, oxedrine is a mandatory component of Tetradium ruticarpum. The quantity of oxedrine in the maximum recommended daily dose must be no more than 30 mg.
4889	TETRAHEXYLDECYL ASCORBATE	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 1%.
4890	TETRAHYDRO LINALYLACETATE	E	Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.
4891	TETRAHYDRO PARA-METHYLQUINOLINE	E	Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.
4892	TETRAHYDRO-6-(3-PENTENYL)-2H-PYRAN-2-ONE	E	Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.
4893	TETRAHYDRODIFERULOYLMETHANE	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.1%.
4894	TETRAHYDROFURFURYL ACETATE	E	Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.
4895	TETRAHYDROGERANYL ACETATE	E	Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.
4896	TETRAHYDROLINALOOL	E	Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.
4897	TETRAHYDROMUGUOL	E	Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.
4898	TETRAHYDROMYRCENOL	E	Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.
4899	TETRAHYDROXYPROPYL ETHYLENEDIAMINE	E	Only for use in topical medicines for dermal application.
4900	TETRAMETHYL ACETYLOCTAHYDRONAPHTHALENES	E	Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.
4901	TETRAPANAX PAPYRIFER	A, H
4902	TETRASODIUM ETIDRONATE	E	Only for use in topical medicines for dermal application.
4903	TETRASODIUM PYROPHOSPHATE	E
4904	TEUCRIUM CHAMAEDRYS	A, H	The maximum recommended daily dose must be no more than 1mg of the equivalent dry herbal material of Teucrium chamaedrys.
4905	TEUCRIUM MARUM	A, H	The maximum recommended daily dose must be no more than 1mg of the equivalent dry herbal material of Teucrium marum.
4906	TEUCRIUM SCORODONIA	A, H	The maximum recommended daily dose must be no more than 1mg of the equivalent dry herbal material of Teucrium scorodonia.
4907	THAPSIA GARGANICA	A, H
4908	THAUMATIN	E
4909	THEANINE	A	Only to be used in a medicine where Trans Chem Pty Ltd (Client ID 21878), who applied to have the ingredient included in this Determination, is the sponsor of the medicine or has given written authorisation to the sponsor of a medicine to include the ingredient in the medicine. This paragraph ceases to be a requirement for this ingredient after 1 March 2026. The route of administration for medicines that contain theanine must be limited to oral. The maximum recommended daily dose of the medicine must not provide more than 450 mg of theanine. The following warning statements (or words to the same effect) are required on the medicine label: - (PREGNT) 'Not recommended for use by pregnant and lactating women'; and - (ADULT) 'Adults only'.
4910	THEASPIRANE	E	Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
4911	THEMEDA TRIANDRA	A, H
4912	THEOBROMA CACAO	A, E, H	Caffeine is a mandatory component of Theobroma cacao. When the medicine is packaged for supply as a divided preparation and is for internal use or oral application, the medicine must not contain a concentration of total caffeine greater than 33%. When for internal use or oral application, the maximum recommended daily dose of the medicine must provide no more than 400 mg of total caffeine. When the medicine is packaged for supply as an undivided preparation and is for internal use or oral application, the medicine must not contain a concentration of total caffeine greater than 1%. When the medicine is for internal use or oral application, a maximum recommended dose of the medicine must not provide more than 100 mg of total caffeine within a 3 hour period. When the maximum recommended daily dose of the medicine provides greater than 10 mg of total caffeine and the medicine is for internal use or oral application, the following warning statements are required on the label: - (ADULT) 'Adults only' (or words to that effect). - (CAFF) 'Contains [state quantity per dosage unit or per mL or per gram of product] total caffeine [per dosage unit or per mL or per gram]. A cup of instant coffee contains approximately 80 mg of caffeine.' - (CAFFPREG) ‘Caffeine intake more than 200 mg per day is not recommended during pregnancy or breastfeeding.’ When the maximum recommended daily dose of the medicine provides greater than 80 mg of total caffeine and the medicines is for internal use or oral application, the following warning statements are required on the label: - (CAFFLMT) 'Limit the use of caffeine-containing products (including tea and coffee) when taking this product.' - (CAFFCYP) ‘Caffeine interacts with enzyme CYP1A2 in the liver. Consult your health professional before taking with other medicines’ (or words to that effect).
4913	THEOBROMA OIL	A, E, H
4914	THIAMINE	A, E
4915	THIAMINE HYDROCHLORIDE	A, E
4916	THIAMINE NITRATE	A, E
4917	THIOCINEOLE	E	Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.
4918	THIOTAURINE	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.02%.
4919	THLASPI ARVENSE	A, E, H
4920	THREONINE	A, E
4921	THUJA OCCIDENTALIS	A, H
4922	THUJA PLICATA	A, E, H
4923	THYME HERB DRY	A, E, H
4924	THYME OIL	A, E, H	When the concentration of Thyme oil in the medicine is more than 50%, the nominal capacity of the container must be no more than 25 mL, a restricted flow insert must be fitted on the container and the medicine requires the warning statement: - (CHILD) 'Keep out of reach of children' (or words to that effect).
4925	THYMOL	A, E	When used as an active ingredient, the medicine must be medicated space spray or medicated throat lozenges. When used as an excipient, only for use in medicated throat lozenges or topical medicines for dermal applications.
4926	THYMOL METHYL ETHER	E	Thymol methyl ether must only be included in medicines when in combination with other permitted ingredients as a flavour proprietary excipient formulation. The total concentration of the flavour proprietary excipient formulation containing thymol methyl ether must not be more than 5% of the total medicine.
4927	THYMUS CAPITATUS	A, E, H	When the plant preparation is an oil, and the concentration in the medicine is more than 50%, the nominal capacity of the container must be no more than 25 mL, a restricted flow insert must be fitted on the container and the medicine requires the following warning statement on the medicine label: - (CHILD) 'Keep out of reach of children' (or words to that effect).
4928	THYMUS GLAND	H	Only for use as an active homoeopathic ingredient.
4929	THYMUS MASTICHINA	A, E, H	When the plant preparation is an oil, and the concentration in the medicine is more than 50%, the nominal capacity of the container must be no more than 25 mL, a restricted flow insert must be fitted on the container and the medicine requires the following warning statement on the medicine label:- (CHILD) 'Keep out of reach of children' (or words to that effect).
4930	THYMUS SERPYLLUM	A, E, H	When the plant preparation is an oil, and the concentration in the medicine is more than 50%, the nominal capacity of the container must be no more than 25 mL, a restricted flow insert must be fitted on the container and the medicine requires the following warning statement on the medicine label:- (CHILD) 'Keep out of reach of children' (or words to that effect).
4931	THYMUS VULGARIS	A, E, H	When the plant preparation is oil or distillate, and the concentration of Thymus vulgaris oil or distillate in the preparation is greater than 50%: (a) the nominal capacity of the container must not be more than 25 millilitres; (b) a restricted flow insert must be fitted on the container; and (c) the following warning statement is required on the medicine label: - (CHILD) 'Keep out of reach of children' (or words to that effect).
4932	THYMUS VULGARIS MIS	A, E, H	When the plant preparation is an oil or distillate, and the concentration of Thymus vulgaris MIS oil or distillate in the preparation is greater than 50%: (a) the nominal capacity of the container must not be more than 25 millilitres; (b) a restricted flow insert must be fitted on the container; and (c) the following warning statement is required on the label: - (CHILD) 'Keep out of reach of children' (or words to that effect).
4933	THYMUS ZYGIS	A, H	When the plant preparation is an oil or a distillate, and the concentration of Thymus zygis oil or distillate in the preparation is greater than 50%: (a) the nominal capacity of the container must not be more than 25 millilitres; (b) a restricted flow insert must be fitted on the container; and (c) the following warning statement is required on the label: - (CHILD) 'Keep out of reach of children' (or words to that effect).
4934	TIGER SNAKE	H	Only for use as an active homoeopathic ingredient.
4935	TILACTASE	A	Must be derived from Aspergillus oryzae and comply with the relevant USP monograph.
4936	TILIA CORDATA	A, E, H
4937	TILIA PLATYPHYLLOS	A, E, H
4938	TILIA TOMENTOSA	A, H
4939	TILIA X VULGARIS	A, E, H
4940	TILIANTOL	E	Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.
4941	TIN	H	Only for use as an active homoeopathic ingredient.
4942	TINOSPORA CORDIFOLIA	A, H
4943	TINOSPORA SINENSIS	A, H
4944	TITANIUM DIOXIDE	A, E	For use as an active ingredient only in sunscreens for dermal application. The concentration in sunscreens must be no more than 25%. For use as an excipient only as a colour and only in medicines limited to oral and topical routes of administration. Not to be included in medicines intended for use in the eye. When used in primary sunscreen products, the following warning statements are required on the label: - (AVOID) 'Avoid prolonged exposure in the sun' (or words to this effect); and - (SUNPRO) 'Wear protective clothing - hats and eyewear when exposed to the sun' (or words to this effect).
4945	TOCOCYSTEAMIDE	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.01%.
4946	TOCOFERSOLAN	E	Only for oral and topical use. When for oral use, the concentration in the medicine must be no more than 10% w/w. When used in topical medicines for dermal application, it is not to be included in medicines intended for use in the eye. When for topical use, the concentration in the medicine must be no more than 0.1%
4947	TOCOPHEROL	E	Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.
4948	TOCOPHERYL GLUCOSIDE	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use on damaged skin or in the eye. The concentration in the medicine must be no more than 0.05%
4949	TOCOPHERYL LINOLEATE	E	Only for use in topical medicines for dermal application.
4950	TOCOPHERYL NICOTINATE	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration must not exceed 0.3%.
4951	TOLU BALSAM	A, E, H
4952	TOLUENE	E	The residual solvent limit for toluene is 8.9 mg per maximum recommended daily dose. The concentration in the medicine must be no more than 0.089%.
4953	TOLYL ALDEHYDE	E	Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.
4954	TOLYLALDEHYDE GLYCERYLACETAL	E	Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
4955	TOMATO	E
4956	TONKA	E	Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.
4957	TONKA BEAN EXTRACT	E	Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.
4958	TONONE	E	Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.
4959	TOXICODENDRON DIVERSILOBUM	H	Only for use as an active homoeopathic ingredient.
4960	TOXICODENDRON PUBESCENS	H	Only for use as an active homoeopathic ingredient. The maximum recommended daily dose must be no more than 1mg of the equivalent dry herbal material of Toxicodendron pubescens.
4961	TOXICODENDRON RADICANS	A, H	The maximum recommended daily dose must be no more than 1mg of the equivalent dry herbal material of Toxicodendron radicans.
4962	TOXICODENDRON SUCCEDANEUM	H	Only for use as an active homoeopathic ingredient.
4963	TRACHELOSPERMUM JASMINOIDES	A, E, H
4964	TRACHYSPERMUM AMMI	A, E	Only for use in oral medicines when the plant part is fruit or seed. The medicine requires the following warning statements on the medicine label: - (PREGNT) 'Not recommended for use by pregnant and lactating women' (or words to that effect) - (PREGNT2) 'Do not use if pregnant or likely to become pregnant' (or words to that effect). Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
4965	TRAGACANTH	A, E
4966	TRAMETES VERSICOLOR	A, H
4967	TRAMETES VERSICOLOR PROTEOGLYCAN CONCENTRATE	A, H	Only for use in oral medicines.
4968	TRANS,TRANS-2,4-DECADIEN-1-AL	E	Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
4969	TRANS,TRANS-2,4-HEXADIENAL	E	Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in the medicine must be no more than 1%. The maximum daily dose must provide no more than 13.5 mg of Trans,Trans-2,4-Hexadienal.
4970	TRANS-1-(2,4,4-TRIMETHYL-2-CYCLOHEXEN-1-YL)-2-BUTEN-1-ONE	E	Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.
4971	TRANS-2-DECENAL	E	Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
4972	TRANS-2-DODECENAL	E	Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.
4973	TRANS-2-HEPTEN-1-AL	E	Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
4974	TRANS-2-HEXENAL	E	Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.
4975	TRANS-2-HEXENOIC ACID	E	Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
4976	TRANS-2-HEXENOL	E	Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.
4977	TRANS-2-HEXENYL ACETATE	E	Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
4978	TRANS-2-HEXENYL PHENYLACETATE	E	Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
4979	TRANS-2-HYDROXYCINNAMIC ACID	E	Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
4980	TRANS-2-OCTENAL	E	trans-2-Octenal must only be included in medicines when in combination with other permitted ingredients as a fragrance proprietary excipient formulation. The total concentration of the fragrance proprietary excipient formulation containing trans-2-octenal must not be more than 1% of the total medicine.
4981	TRANS-2-UNDECENAL	E	Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
4982	TRANS-3-HEXENOIC ACID	E	Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
4983	TRANS-4-DECENAL	E	Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.
4984	TRANS-8-(1-METHYLETHYL)-1-OXASPIRO(4.5)DECAN-2-ONE	E	Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.
4985	TRANS-ETHYL 2-OCTENOATE	E	Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
4986	TRANS-METHYL-2-HEXENOATE	E	Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%.
4987	TREACLE	E	When for oral or sublingual use, sucrose is a mandatory component of treacle.
4988	TREEMOSS ABSOLUTE	E	Permitted for use only in combination with other permitted ingredients as part of a fragrance proprietary excipient formulation. When included in a medicine for use on the lips the concentration of treemoss absolute must be no more than 0.02%. When for dermal use or use on the hair the concentration of treemoss absolute must be no more than 0.1% The total fragrance proprietary excipient formulation in a medicine must be no more than 1%.
4989	TREFRIW WELLS MINERAL WATER	A	When for internal use, iron is a mandatory component of Trefriw Wells mineral water. Solid dosage forms containing more than 5 milligrams of elemental iron in each dosage unit are required to have a child resistant closure. Liquid Preparations containing more than 250 milligrams of elemental iron in the total contents of the container are required to have a child resistant closure. Only able to be used when presented in single use sachets for therapeutic use as an iron supplement.
4990	TREHALOSE DIHYDRATE	E	When for oral use and the quantity of trehalose dihydrate per maximum recommended daily dose exceeds 20 grams, the quantity of trehalose dihydrate must be declared on the label.
4991	TREMELLA FUCIFORMIS	A, H
4992	TRIACETIN	E
4993	TRIACONTANYL PVP	E	Only for use in topical medicines for dermal application.
4994	TRIADICA SEBIFERA	A, H
4995	TRIBASIC POTASSIUM PHOSPHATE	A, E, H	When used as an active ingredient and the medicine is intended as a mineral supplementation, potassium is a mandatory component of tribasic potassium phosphate. When used in a solid medicine containing this ingredient, the pH of a 10 g/L aqueous solution must not be more than 11.5. When used in a liquid or a semi-solid medicine containing this ingredient, the pH of the medicine must be no more than 11.5.
4996	TRIBASIC SODIUM PHOSPHATE	E	When used in a solid preparation, the pH of a 10 g/L aqueous solution must not be more than 11.5. When used in a liquid or a semi-solid preparation, the pH of the preparation must not exceed 11.5.
4997	TRIBEHENIN	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 6%.
4998	TRIBEHENIN PEG-20 ESTERS	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 6%.
4999	TRIBULUS TERRESTRIS	A, E, H
5000	TRIBUTYL ACETYLCITRATE	E	Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.
5001	TRICALCIUM PHOSPHATE	E
5002	TRICAPRYLIN	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 5%.
5003	TRICAPRYLYL CITRATE	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 7%.
5004	TRICETEARETH-4 PHOSPHATE	E	Only for use in topical medicines for dermal application.
5005	TRICHLOROMETHYLPHENYLCARBINYL ACETATE	E	Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.
5006	TRICHODERMA VIRIDE	A, E, H
5007	TRICHOSANTHES KIRILOWII	A, E, H
5008	TRICLOSAN	E	The concentration in the medicine must be no more than 1%.
5009	TRICYCLODECENYL PROPIONATE	E	Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.
5010	TRIDECANAL	E	Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.
5011	TRIDECETH-4 PHOSPHATE	E	Only for use in topical medicines for dermal application.
5012	TRIDECETH-6	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye or on damaged skin. The concentration in the medicine must be no more than 0.5%.
5013	TRIDECYL ALCOHOL	E	Permitted for use only in combination with other permitted ingredients as a fragrance. If used as in a fragrance the total fragrance concentration in a medicine must be no more than 1%.
5014	TRIDECYL BEHENATE	E	Behenic acid is a mandatory component of Tridecyl behenate. Only for use in topical medicines for dermal application.
5015	TRIDECYL NEOPENTANOATE	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 23%.
5016	TRIDECYL SALICYLATE	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 5%.
5017	TRIDECYL STEARATE	E	Only for use in topical medicines for dermal application.
5018	TRIDECYL TRIMELLITATE	E	Only for use in topical medicines for dermal application.
5019	TRIETHOXYCAPRYLYLSILANE	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye or on damaged skin. The concentration in the medicine must be no more than 1%.
5020	TRIETHYL CITRATE	E
5021	TRIETHYLENE GLYCOL	E
5022	TRIFOLIUM PRATENSE	A, E, H
5023	TRIFOLIUM REPENS	A, H
5024	TRIGONELLA FOENUM-GRAECUM	A, E, H
5025	TRIHYDROXYPALMITAMIDOHYDROXYPROPYL MYRISTYL ETHER	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.02%.
5026	TRIHYDROXYSTEARIN	E	Only for use in topical medicines for dermal application.
5027	TRIISOCETYL CITRATE	E	Only for use in topical medicines for dermal application.
5028	TRIISODECYL TRIMELLITATE	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 5%.
5029	TRIISONONANOIN	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 5%.
5030	TRIISOSTEARIN	E	Only for use in topical medicines for dermal application.
5031	TRILAURIN	E	Only for use in topical medicines for dermal application.
5032	TRILISA ODORATISSIMA	A, H
5033	TRILLIUM ERECTUM	A, H
5034	TRIMETHOXYCAPRYLYL SILANE	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.25%.
5035	TRIMETHYL HYDROXYPENTYL ISOBUTYRATE	E	Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.
5036	TRIMETHYL UNDECYLENIC ALDEHYDE	E	Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.
5037	TRIMETHYL-BICYCLO-HEPTANE-SPIROCYCLOHEXENONE	E	Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.
5038	TRIMETHYLBENZENEPROPANOL	E	Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.
5039	TRIMETHYLHEXANOL	E	Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.
5040	TRIMETHYLOPROPANE TRIOCTANOATE	E	Only for use in topical medicines for dermal application.
5041	TRIMETHYLPENTANEDIOL/ADIPIC ACID/GLYCERIN CROSSPOLYMER	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 5%.
5042	TRIMETHYLSILOXYSILICATE	E	Only for use in topical medicines for dermal application.
5043	TRINITROPHENOL	H	Only for use as an active homoeopathic ingredient. The total concentration of trinitrophenol in the medicine must not be more than 10 mg/kg or 10 mg/L or 0.001%.
5044	TRIOCTANOIN	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 5%.
5045	TRIOCTYLDODECYL CITRATE	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 12%.
5046	TRIOLEIN	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.1%.
5047	TRIOSTEUM PERFOLIATUM	A, H
5048	TRIOXAUNDECANEDIOIC ACID	E
5049	TRIPEPTIDE-1	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye or on damaged skin. The concentration in the medicine must be no more than 0.002%.
5050	TRIS-BIPHENYL TRIAZINE	A	Only for use as an active ingredient in sunscreens for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must not be more than 10%. When used topically, the dosage form must not be spray. When used in primary sunscreen products, the following warning statements are required on the label: - (AVOID) 'Avoid prolonged exposure in the sun' (or words to this effect); and - (SUNPRO) 'Wear protective clothing - hats and eyewear when exposed to the sun' (or words to this effect).
5051	TRISILOXANE	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 40%.
5052	TRISODIUM EDETATE	E	Only for use in topical medicines for dermal application.
5053	TRISODIUM ETHYLENEDIAMINE DISUCCINATE	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.2%.
5054	TRISODIUM NTA	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.005%.
5055	TRISTEARIN	E
5056	TRITICUM AESTIVUM	A, E, H	Gluten is a mandatory component when the plant part is seed and the route of administration is other than topical and mucosal.
5057	TRITICUM DURUM	A, E, H	Gluten is a mandatory component when the plant part is seed and the route of administration is other than topical and mucosal.
5058	TRIUNDECANOIN	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 11.2%.
5059	TROLAMINE	E	Only for use in topical medicines for dermal application. The concentration in the medicine must be no more than 5%.
5060	TROLAMINE LAURIL SULFATE	E	Only for use in topical medicines for dermal application.
5061	TROLAMINE SALICYLATE	A	Only for use as an active ingredient in sunscreens for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must not be more than 12%. When used in primary sunscreen products, the following warning statements are required on the label: - (AVOID) 'Avoid prolonged exposure in the sun' (or words to this effect); and - (SUNPRO) 'Wear protective clothing - hats and eyewear when exposed to the sun' (or words to this effect).
5062	TROLLIUS CHINENSIS	A, H
5063	TROMETAMOL	E
5064	TROMETAMOL HYDROCHLORIDE	E
5065	TROPAEOLUM MAJUS	A, E, H
5066	TROPICAL RATTLESNAKE	H	Only for use as an active homoeopathic ingredient.
5067	TROPOLONE	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.01%.
5068	TSUGA CANADENSIS	A, H
5069	TULIPA EDULIS	A, H	Colchicine is a mandatory component of Tulipa edulis. The concentration of colchicine in the medicine must be no more than 10 mg/kg or 10 mg/L or 0.001%.
5070	TURMERIC	E	Permitted for use only in combination with other permitted ingredients as a colour.
5071	TURNERA DIFFUSA	A, E, H	Beta-arbutin is a mandatory component of Turnera diffusa. When for oral use, the maximum recommended daily dose must not provide more than 500 mg of beta-arbutin. When for dermal application exclusively to the face: a) the concentration of beta-arbutin in the medicine must not be more than 7%; b) hydroquinone is a mandatory component; and c) the concentration of hydroquinone must not be more than 10 mg/kg or 10 mg/L or 0.001%. When for use other than oral or dermal application exclusively to the face, the concentration of beta-arbutin in the medicine must not be more than 10 mg/kg or 10 mg/L or 0.001%.
5072	TURNIP	E
5073	TURPENTINE OIL	A, E	Only permitted for use when turpentine oil is derived from sources other than mineral turpentine. The concentration in the medicine must not be more than 25%.
5074	TYPHA ANGUSTIFOLIA	A, H
5075	TYPHA LATIFOLIA	A, H
5076	TYPHONIUM GIGANTEUM	A, H
5077	TYROSINE	A, E