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
3640	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%.
3641	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%.
3642	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).
3643	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%.
3644	PAEONIA LACTIFLORA	A, E, H
3645	PAEONIA OBOVATA	A, H
3646	PAEONIA SUFFRUTICOSA	A, E, H
3647	PAEONIA VEITCHII	A, H
3648	PALIURUS SPINA-CHRISTI	A, H
3649	PALLADIUM	H	Only for use as an active homoeopathic ingredient.
3650	PALM FRUIT OIL	A, E, H
3651	PALM GLYCERIDES	E
3652	PALM KERNEL OIL	A, E, H
3653	PALM TOCOTRIENOLS COMPLEX	A, H
3654	PALMARIA PALMATA	A, H
3655	PALMAROSA OIL	A, E, H
3656	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.’
3657	PALMITIC ACID	E
3658	PALMITOLEIC ACID-RICH FATTY ACID ETHYL ESTERS	A
3659	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%.
3660	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%
3661	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%.
3662	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%.
3663	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%.
3664	PANAX GINSENG	A, E, H
3665	PANAX JAPONICUS	A, H
3666	PANAX NOTOGINSENG	A, H
3667	PANAX PSEUDOGINSENG	A, H
3668	PANAX QUINQUEFOLIUS	A, H
3669	PANICUM MILIACEUM	A, H
3670	PANTETHINE	E	Only for use in topical medicines for dermal application.
3671	PANTHENOL	A, E
3672	PANTHENYL ETHYL ETHER	E	Only for use in topical medicines for dermal application.
3673	PANTOLACTONE	E
3674	PANTOTHENIC ACID	A, E	When used topically, the concentration in the medicine must be no more than 0.1%.
3675	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%.
3676	PAPAIN	A, E
3677	PAPER	E	Only for use in topical medicines for dermal application.
3678	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%.
3679	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%.
3680	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%.
3681	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%.
3682	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%.
3683	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%.
3684	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%.
3685	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.
3686	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%.
3687	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%.
3688	PARA-HYDROXYBENZOIC ACID	E
3689	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%.
3690	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%.
3691	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%.
3692	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%.
3693	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.
3694	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%.
3695	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%.
3696	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%.
3697	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%.
3698	PARAMERIA LAEVIGATA	A, H
3699	PARIETARIA JUDAICA	A, H
3700	PARIS POLYPHYLLA	A, H
3701	PARIS QUADRIFOLIA	A, H
3702	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.
3703	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.
3704	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.
3705	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.
3706	PARTHENOCISSUS TRICUSPIDATA	A, H
3707	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.
3708	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%.
3709	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%.
3710	PASPALUM NOTATUM	A, H
3711	PASSIFLORA CAERULEA	A, H
3712	PASSIFLORA EDULIS	E
3713	PASSIFLORA HERB DRY	A, H
3714	PASSIFLORA INCARNATA	A, E, H
3715	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%.
3716	PATENT BLUE V	E	Permitted for use only as a colour in medicines limited to topical and oral routes of administration.
3717	PATENT BLUE V ALUMINIUM LAKE	E	Permitted for use only as a colour in medicines limited to topical and oral routes of administration.
3718	PATRINIA SCABIOSIFOLIA	A, H
3719	PATRINIA VILLOSA	A, H
3720	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).
3721	PAULLINIA PINNATA	A, H
3722	PAWPAW	E
3723	PEA	E
3724	PEA STARCH	E
3725	PEACH	E
3726	PEAR	E
3727	PECAN	E
3728	PECTIN	A, E
3729	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%.
3730	PEG-10 SOYA STEROL	E	Only for use in topical medicines for dermal application.
3731	PEG-100 STEARATE	E	Only for use in topical medicines for dermal application.
3732	PEG-12 DILAURATE	E
3733	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%.
3734	PEG-120 METHYL GLUCOSE DIOLEATE	E	Only for use in topical medicines for dermal application.
3735	PEG-120 STEARATE	E	Only for use in topical medicines for dermal application.
3736	PEG-15 COCAMINE	E	Only for use in topical medicines for dermal application.
3737	PEG-150 DISTEARATE	E	Only for use in topical medicines for dermal application.
3738	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%.
3739	PEG-20 METHYL GLUCOSE DISTEARATE	E	Only for use in topical medicines for dermal application.
3740	PEG-20 METHYL GLUCOSE SESQUISTEARATE	E	Only for use in topical medicines for dermal application.
3741	PEG-20 SORBITAN ISOSTEARATE	E	Only for use in topical medicines for dermal application.
3742	PEG-20 STEARATE	E	Only for use in topical medicines for dermal application.
3743	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).
3744	PEG-30 DIPOLYHYDROXYSTEARATE	E	Only for use in topical medicines for dermal application.
3745	PEG-30 STEARATE	E	Only for use in topical medicines for dermal application.
3746	PEG-35 CASTOR OIL	E
3747	PEG-4 DILAURATE	E	Only for use in topical medicines for dermal application.
3748	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%.
3749	PEG-4 STEARATE	E	Only for use in topical medicines for dermal application.
3750	PEG-40 CASTOR OIL	E
3751	PEG-40 HYDROGENATED CASTOR OIL	E
3752	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%.
3753	PEG-40 STEARATE	E	Only for use in topical medicines for dermal application.
3754	PEG-45/DODECYL GLYCOL COPOLYMER	E	Only for use in topical medicines for dermal application.
3755	PEG-5 GLYCERYL STEARATE	E	Only for use in topical medicines for dermal application.
3756	PEG-50 STEARATE	E	Only for use in topical medicines for dermal application.
3757	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%.
3758	PEG-6 LAURAMIDE	E	Only for use in topical medicines for dermal application.
3759	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%.
3760	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%.
3761	PEG-60 HYDROGENATED CASTOR OIL	E	Only for use in topical medicines for dermal application.
3762	PEG-7 COCAMIDE	E	Only for use in topical medicines for dermal application.
3763	PEG-7 GLYCERYL COCOATE	E	Only for use in topical medicines for dermal application.
3764	PEG-7 HYDROGENATED CASTOR OIL	E	Only for use in topical medicines for dermal application.
3765	PEG-75 LANOLIN	E	Only for use in topical medicines for dermal application.
3766	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%.
3767	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%.
3768	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%.
3769	PEG-8 DISTEARATE	E	Only for use in topical medicines for dermal application.
3770	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.
3771	PEG-8 PROPYLENE GLYCOL COCOATE	E
3772	PEG-8 STEARATE	E	Only for use in topical medicines for dermal application.
3773	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%.
3774	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%.
3775	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%.
3776	PELARGONIUM GRAVEOLENS	A, E, H
3777	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%.
3778	PELTIGERA CANINA	A, H
3779	PENICILLIUM EXPANSUM	A, H
3780	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.
3781	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%
3782	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%.
3783	PENTAERYTHRITYL TETRALAURATE	E	Only for use in topical medicines for dermal application. The concentration in the medicine must be no more than 80%.
3784	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%.
3785	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%.
3786	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%.
3787	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%.
3788	PEPPER BLACK	E, H
3789	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%.
3790	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.
3791	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.
3792	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.
3793	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.
3794	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.
3795	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.
3796	PERFLUOROPOLYMETHYLISOPROPYL ETHER	E	Only for use in topical medicines for dermal application.
3797	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%.
3798	PERILLA FRUTESCENS	A, E, H
3799	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%.
3800	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%.
3801	PERMETHRIN	E	The total concentration of permethrin in the medicine must not be more than 2%.
3802	PERSEA AMERICANA	A, E, H
3803	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.
3804	PERSICARIA CHINENSIS	A, H
3805	PERSICARIA TINCTORIA	A, H
3806	PERU BALSAM	A, E, H
3807	PERU BALSAM OIL	A, E, H
3808	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%
3809	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%.
3810	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%.
3811	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.
3812	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%.
3813	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.
3814	PEUCEDANUM PRAERUPTORUM	A, E, H
3815	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).
3816	PHALARIS ARUNDINACEA	A, H
3817	PHALARIS CANARIENSIS	A, H
3818	PHASEOLUS COCCINEUS	A, H
3819	PHASEOLUS VULGARIS	A, H
3820	PHELLINUS ROBINIAE	A, E, H
3821	PHELLODENDRON AMURENSE	A, E, H
3822	PHELLODENDRON CHINENSE	A, H
3823	PHENACETIN	E	Only for use in topical medicines for dermal application. The concentration in the medicine must be no more than 0.1%.
3824	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%.
3825	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%.
3826	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%.
3827	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%.
3828	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%
3829	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%.
3830	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%.
3831	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%.
3832	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%.
3833	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%.
3834	PHENOL	E	Only for use in topical medicines for dermal application. The concentration of phenol in the medicine must be no more than 1%.
3835	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%.
3836	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%.
3837	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%.
3838	PHENOXYETHYLPARABEN	E	Only for use in topical medicines for dermal application.
3839	PHENYL DIMETHICONE	E	Only for use in topical medicines for dermal application.
3840	PHENYL TRIMETHICONE	E	Only for use in topical medicines for dermal application.
3841	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%.
3842	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%.
3843	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%.
3844	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%.
3845	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'.
3846	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).
3847	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%.
3848	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%.
3849	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%.
3850	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%.
3851	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%.
3852	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%.
3853	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%.
3854	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%.
3855	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%.
3856	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%.
3857	PHLEUM PRATENSE	A, H	Only permitted in preparations other than phleum pratense pollen extract.
3858	PHLOXINE B	E	Permitted for use only as a colour in medicines limited to topical and oral routes of administration.
3859	PHLOXINE B ALUMINIUM LAKE	E	Permitted for use only as a colour in medicines limited to topical and oral routes of administration.
3860	PHOENIX DACTYLIFERA	A, E, H
3861	PHOSPHATIDYL CHOLINE	E
3862	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%.
3863	PHOSPHORIC ACID	E, H	The concentration in liquid medicines must be no more than 15%.
3864	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%.
3865	PHOTINIA SERRULATA	A, H
3866	PHRAGMITES AUSTRALIS	A, H
3867	PHYLLANTHUS AMARUS	A, H
3868	PHYLLANTHUS EMBLICA	A, E, H	When used as an excipient, only for use in topical medicines for dermal application.
3869	PHYLLOSTACHYS NIGRA	A, E, H
3870	PHYSALIS ALKEKENGI	A, H
3871	PHYSALIS PUBESCENS	A, H
3872	PHYTANTRIOL	E	Only for use in topical medicines for dermal application. The concentration in the medicine must be no more than 0.5%.
3873	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%.
3874	PHYTOLACCA AMERICANA	A, H	The maximum recommended daily dose of the medicine must contain no more than 1mg of the equivalent dry herb.
3875	PHYTOMENADIONE	A, E
3876	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%.
3877	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%.
3878	PICEA ABIES	A, H
3879	PICEA MARIANA	A, H
3880	PICRASMA EXCELSA	A, E, H
3881	PICRORRHIZA KURROA	A, E, H
3882	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%.
3883	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%.
3884	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%.
3885	PIGMENT RED 4	E	Permitted for use only as a colour for topical use.
3886	PIGMENT RED 53	E	Permitted for use only as a colour for topical use.
3887	PIGMENT RED 57	E	Permitted for use only as a colour for topical use.
3888	PIGMENT RED 57 ALUMINIUM LAKE	E	Permitted for use only as a colour for topical use.
3889	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.
3890	PIGMENT RED 63	E	Permitted for use only as a colour for topical use.
3891	PIGMENT WHITE 26	E	Permitted for use only as a colour for topical use.
3892	PIGMENT YELLOW 12	E	Permitted for use only as a colour for topical use.
3893	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%.
3894	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%.
3895	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%.
3896	PIMENTA FRUIT OIL	A, E, H
3897	PIMENTA LEAF OIL	A, E, H
3898	PIMENTA OFFICINALIS	A, E, H
3899	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'.
3900	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).
3901	PIMPINELLA SAXIFRAGA	A, E, H
3902	PINE NEEDLE OIL SCOTCH	A, E, H
3903	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%.
3904	PINE OIL AROMATIC	A, E, H
3905	PINE OIL PUMILIO	A, E, H
3906	PINEAPPLE	E
3907	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%.
3908	PINELLIA TERNATA	A, H
3909	PINUS CONTORTA	A, E, H
3910	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%.
3911	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%.
3912	PINUS MONTICOLA	A, E, H
3913	PINUS MUGO	A, E, H
3914	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%.
3915	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%.
3916	PINUS PONDEROSA	A, E, H
3917	PINUS RADIATA	A, E, H
3918	PINUS STROBUS	A, E, H
3919	PINUS SYLVESTRIS	A, E, H
3920	PINUS TABULIFORMIS	A, E, H
3921	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%.
3922	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%.
3923	PIPER CHABA	A, E, H
3924	PIPER CUBEBA	A, E, H
3925	PIPER KADSURA	A, E, H
3926	PIPER LONGUM	A, E, H
3927	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.
3928	PIPER NIGRUM	A, E, H
3929	PIPER SARMENTOSUM	A, E, H
3930	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%.
3931	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%.
3932	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%.
3933	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%.
3934	PIPERONYL BUTOXIDE	E	Only for use in topical medicines for dermal application.
3935	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.
3936	PISCIDIA PISCIPULA	A, E, H
3937	PISTACIA LENTISCUS	A, E, H
3938	PISUM SATIVUM	A, E, H
3939	PLACENTA	H	Only for use as an active homoeopathic ingredient.
3940	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).
3941	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).
3942	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).
3943	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).
3944	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).
3945	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).
3946	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).
3947	PLATANUS OCCIDENTALIS	A, E, H
3948	PLATANUS RACEMOSA	A, H
3949	PLATANUS × HISPANICA	A, H
3950	PLATYCODON GRANDIFLORUS	A, E, H
3951	PLECTRANTHUS BARBATUS	A, E, H
3952	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%.
3953	PLUM	E
3954	PLUMBAGO EUROPAEA	A, H
3955	PLUMERIA ALBA	A, E, H
3956	PLUMERIA RUBRA	A, E, H
3957	POA NEMORALIS	A, H
3958	POA PRATENSIS	A, H
3959	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%.
3960	POGOSTEMON CABLIN	A, E, H
3961	POLACRILIN	E
3962	POLACRILIN POTASSIUM	E
3963	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).
3964	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.
3965	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.
3966	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.
3967	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).
3968	POLOXAMER	E	Only for use in topical medicines for dermal application.
3969	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%.
3970	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%.
3971	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%.
3972	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%.
3973	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.
3974	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%.
3975	POLYACRYLIC ACID	E
3976	POLYAMINO SUGAR CONDENSATE	E	Only for use in topical medicines for dermal application.
3977	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%.
3978	POLYBUTADIENE	E	Only for use as part of an adhesive in topical medicines for dermal application.
3979	POLYBUTENE	E	Only for use in topical medicines for dermal application.
3980	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%.
3981	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%.
3982	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%.
3983	POLYDEXTROSE	E
3984	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%.
3985	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%
3986	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%.
3987	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%.
3988	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%.
3989	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%.
3990	POLYETHYLENE	E
3991	POLYGALA CHINENSIS	A, H
3992	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.
3993	POLYGALA SIBIRICA	A, E, H	Only for use when the plant part is root or root bark.
3994	POLYGALA TENUIFOLIA	A	Only for use when the plant part is root or root bark.
3995	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%.
3996	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%.
3997	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%.
3998	POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE	E	Only for use in topical medicines for dermal application. The concentration in the medicine must be no more than 5%.
3999	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%.
4000	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%.
4001	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%.
4002	POLYGLYCERYL-2-PEG-4 STEARATE	E	Only for use in topical medicines for dermal application.
4003	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%.
4004	POLYGLYCERYL-3 DIISOSTEARATE	E	Only for use in topical medicines for dermal application.
4005	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%.
4006	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%.
4007	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%.
4008	POLYGLYCERYL-3 POLYRICINOLEATE	E
4009	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%.
4010	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%.
4011	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%.
4012	POLYGLYCERYL-4 OLEATE	E	Only for use in topical medicines for dermal application.
4013	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%.
4014	POLYGLYCERYL-6 RICINOLEATE	E	Only for use in topical medicines for dermal application.
4015	POLYGONATUM MULTIFLORUM	A, H
4016	POLYGONATUM OFFICINALE	A, H
4017	POLYGONATUM SIBIRICUM	A, E, H
4018	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%.
4019	POLYGONUM BISTORTA	A, H
4020	POLYGONUM ODORATUM	A, H
4021	POLYHYDROXYSTEARIC ACID	E	Only for use in topical medicines for dermal application.
4022	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.
4023	POLYISOPRENE	E	Only for use in topical medicines for dermal application.
4024	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%.
4025	POLYMETHACRYLIC ACID	E
4026	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%.
4027	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%.
4028	POLYPORUS UMBELLATUS	A, H
4029	POLYPROPYLENE	E	Only for use in topical medicines for dermal application.
4030	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%.
4031	POLYQUATERNIUM-10	E	Only for use in topical medicines for dermal application.
4032	POLYQUATERNIUM-11	E	Only for use in topical medicines for dermal application.
4033	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%.
4034	POLYQUATERNIUM-24	E	Only for use in topical medicines for dermal application.
4035	POLYQUATERNIUM-28	E	Only for use in topical medicines for dermal application.
4036	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%.
4037	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%.
4038	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%.
4039	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%.
4040	POLYQUATERNIUM-7	E	Only for use in topical medicines for dermal application.
4041	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%
4042	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%.
4043	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).
4044	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%.
4045	POLYSORBATE 20	E
4046	POLYSORBATE 40	E
4047	POLYSORBATE 60	E
4048	POLYSORBATE 65	E
4049	POLYSORBATE 80	E
4050	POLYSORBATE 85	E	Only for use in topical medicines for dermal application.
4051	POLYSTYRENE	E	Only for use as part of an adhesive in topical medicines for dermal application.
4052	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%.
4053	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.
4054	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%.
4055	POLYVINYL ACETATE	E	Only permitted for use in medicines that are for oral routes of administration.
4056	POLYVINYL ACETATE PHTHALATE	E
4057	POLYVINYL ALCOHOL	E
4058	POLYVINYL CHLORIDE	E	Only for use in topical medicines for dermal application.
4059	POMEGRANATE	E
4060	PONCEAU SX	E	Permitted for use only as a colour for topical use.
4061	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.
4062	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%.
4063	PONTEDERIA CRASSIPES	A, H
4064	POPPY SEED	E, H
4065	POPPY SEED OIL	E, H
4066	POPULUS ALBA	A, H
4067	POPULUS BALSAMIIFERA	A, E, H
4068	POPULUS CANDICANS	A, H
4069	POPULUS DELTOIDES	A, H
4070	POPULUS NIGRA	A, H
4071	POPULUS TREMULA	A, H
4072	POPULUS TREMULOIDES	A, H
4073	PORCINE	H	Only for use as an active homoeopathic ingredient.
4074	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%.
4075	PORTULACA OLERACEA	A, E, H
4076	POTABLE WATER	E
4077	POTASSIUM ACETATE	E
4078	POTASSIUM ARSENITE	H	Only for use as an active homoeopathic ingredient.
4079	POTASSIUM ASCORBATE	A, E, H	When for oral or sublingual use, potassium is a mandatory component of potassium ascorbate.
4080	POTASSIUM ASCORBATE DIHYDRATE	A, E, H	When for oral or sublingual use, potassium is a mandatory component of potassium ascorbate dihydrate.
4081	POTASSIUM ASCORBYL TOCOPHERYL PHOSPHATE	E	Only for use in topical medicines for dermal application.
4082	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.
4083	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.
4084	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.
4085	POTASSIUM BICARBONATE	E
4086	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%.
4087	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.
4088	POTASSIUM CETYL PHOSPHATE	E	Only for use in topical medicines for dermal application.
4089	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: - (POTAS1) '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%.
4090	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.
4091	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%.
4092	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%.
4093	POTASSIUM DICHROMATE	H	Only for use as an active homoeopathic ingredient.
4094	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.
4095	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.
4096	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.
4097	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: ‘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.
4098	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.
4099	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%.
4100	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%.
4101	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%.
4102	POTASSIUM NITRATE	A, H	Only for dental use. The concentration in the medicine must be no more than 5%.
4103	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.
4104	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%.
4105	POTASSIUM SORBATE	E
4106	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%.
4107	POTASSIUM STEARATE	E	Only for use in topical medicines for dermal application.
4108	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.
4109	POTATO STARCH	E
4110	POTENTILLA ANSERINA	A, H
4111	POTENTILLA CHINENSIS	A, H
4112	POTENTILLA DISCOLOR	A, H
4113	POTENTILLA ERECTA	A, E, H
4114	POTENTILLA REPTANS	A, H
4115	POTERIUM OFFICINALE	A, E, H
4116	POTERIUM SANGUISORBA	A, H
4117	POVIDONE	E
4118	POWDERED CELLULOSE	E
4119	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%.
4120	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%.
4121	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%.
4122	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%.
4123	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%.
4124	PPG-2 LANOLIN ALCOHOL ETHER	E	Only for use in topical medicines for dermal application.
4125	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%.
4126	PPG-20 LANOLIN ALCOHOL ETHER	E	Only for use in topical medicines for dermal application.
4127	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%.
4128	PPG-20 METHYL GLUCOSE ETHER DISTEARATE	E	Only for use in topical medicines for dermal application.
4129	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%.
4130	PPG-3 MYRISTYL ETHER	E	Only for use in topical medicines for dermal application.
4131	PPG-5-CETETH-20	E	Only for use in topical medicines for dermal application.
4132	PPG-5-LAUROMACROGOL 250	E	Only for use in topical medicines for dermal application.
4133	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%.
4134	PREGELATINISED MAIZE STARCH	E
4135	PREGELATINISED POTATO STARCH	E
4136	PREGELATINISED RICE STARCH	E
4137	PREGELATINISED STARCH	E
4138	PREGELATINISED WHEAT STARCH	E	When the route of administration is other than topical or mucosal, gluten is a mandatory component of pregelatinised wheat starch.
4139	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%.
4140	PRICKLY ASH BARK DRY	A, H
4141	PRICKLY ASH BARK POWDER	A, H
4142	PRIMULA VERIS	A, E, H
4143	PRIMULA VULGARIS	A, E, H
4144	PRINSEPIA UNIFLORA	A, H
4145	PROBOSCIDEA PARVIFLORA	A, H
4146	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%.
4147	PROLINE	A, E
4148	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%.
4149	PROPANE	E	Only for use as an excipient propellant ingredient.
4150	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%.
4151	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%.
4152	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%.
4153	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%.
4154	PROPIONYLLEVOCARNITINE HYDROCHLORIDE	A, H
4155	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.'
4156	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.'
4157	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.'
4158	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.'
4159	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.'
4160	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.'
4161	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%.
4162	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%.
4163	PROPYL GALLATE	E
4164	PROPYL HYDROXYBENZOATE	E
4165	PROPYLENE CARBONATE	E	Only for use in topical medicines for dermal application.
4166	PROPYLENE GLYCOL	E
4167	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%.
4168	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%.
4169	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%.
4170	PROPYLENE GLYCOL DIOCTANOATE	E	Only for use in topical medicines for dermal application.
4171	PROPYLENE GLYCOL DIOCTANOATE/DIDECANOATE	E	Only for use in topical medicines for dermal application.
4172	PROPYLENE GLYCOL DIPELARGONATE	E	Only for use in topical medicines for dermal application.
4173	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%.
4174	PROPYLENE GLYCOL ISOSTEARATE	E	Only for use in topical medicines for dermal application.
4175	PROPYLENE GLYCOL MONOLAURATE	E	Only for use in topical medicines for dermal application.
4176	PROPYLENE GLYCOL MONOSTEARATE	E	Only for use in topical medicines for dermal application.
4177	PROPYLENE GLYCOL MYRISTYL ETHER ACETATE	E	Only for use in topical medicines for dermal application.
4178	PROSOPIS JULIFLORA	A, H
4179	PROTEASE	A	Must be derived from Aspergillus oryzae or Aspergillus niger.
4180	PROTEIN HYDROLYSATE	E
4181	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%.
4182	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%.
4183	PRUNELLA VULGARIS	A, H
4184	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.
4185	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.
4186	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.
4187	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.
4188	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.
4189	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.
4190	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.
4191	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.
4192	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.
4193	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.
4194	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.
4195	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.
4196	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.
4197	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.
4198	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.
4199	PRUSSIAN BLUE	E	Permitted for use only as a colour for topical use.
4200	PSEUDOCYDONIA SINENSIS	A, H
4201	PSEUDOSTELLARIA HETEROPHYLLA	A, E, H
4202	PSEUDOTSUGA MENZIESII	A, H
4203	PSEUDOWINTERA COLORATA	A, H	Only for use when the plant part is leaf.
4204	PSIDIUM GUAJAVA	A, E, H
4205	PSORINUM	H	Only for use as an active homoeopathic ingredient.
4206	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).
4207	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).
4208	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).
4209	PTELEA TRIFOLIATA	A, H
4210	PTEROCARPUS MARSUPIUM	A, H
4211	PTEROCARPUS SANTALINUS	A, E, H
4212	PUERARIA LOBATA	A, E, H
4213	PUERARIA MONTANA VAR. LOBATA	A, E, H
4214	PULLULAN	E
4215	PUMICE	E
4216	PUMPKIN	E
4217	PUMPKIN SEED OIL	E, H
4218	PUNICA GRANATUM	A, E, H
4219	PURE BEE VENOM	H	Only for use as an active homoeopathic ingredient.
4220	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).
4221	PURIFIED SILICEOUS EARTH	E, H
4222	PURIFIED TALC	E
4223	PURIFIED WATER	E
4224	PVM/MA COPOLYMER	E
4225	PVM/MA DECADIENE CROSSPOLYMER	E	Only for use in topical medicines for dermal application.
4226	PVP/EICOSENE COPOLYMER	E	Only for use in topical medicines for dermal application.
4227	PVP/HEXADECENE COPOLYMER	E	Only for use in topical medicines for dermal application.
4228	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).
4229	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].
4230	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].'
4231	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].'
4232	PYROGLUTAMIC ACID	E
4233	PYROLA DECORATA	A, H
4234	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%.
4235	PYRROSIA LINGUA	A, H
4236	PYRROSIA PETIOLOSA	A, H
4237	PYRROSIA SHEARERI	A, H
4238	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%.
4239	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%.
4240	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%.
4241	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%.
4242	QUASSIA AMARA	A, E, H
4243	QUASSIA WOOD JAMAICAN DRY	A, H
4244	QUASSIA WOOD JAMAICAN POWDER	A, H
4245	QUATERNIUM-15	E	Only for use in topical medicines for dermal application.
4246	QUATERNIUM-18 BENTONITE	E	Only for use in topical medicines for dermal application.
4247	QUATERNIUM-18 HECTORITE	E	Only for use in topical medicines for dermal application.
4248	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.
4249	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%.
4250	QUERCETIN	A
4251	QUERCETIN DIHYDRATE	A
4252	QUERCUS ACUTISSIMA	A, H
4253	QUERCUS ALBA	A, E, H
4254	QUERCUS PALUSTRIS	A, H
4255	QUERCUS ROBUR	A, H
4256	QUERCUS RUBRA	A, H
4257	QUERCUS VIRGINIANA	A, H
4258	QUILLAIA DRY	A, H
4259	QUILLAIA POWDER	A, E, H
4260	QUILLAJA SAPONARIA	A, H
4261	QUINCE	E
4262	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.
4263	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.
4264	QUINOLINE YELLOW	E	Permitted for use only as a colour for oral and topical use.
4265	QUINOLINE YELLOW ALUMINIUM LAKE	E	Permitted for use only as a colour for oral and topical use.
4266	QUISQUALIS INDICA	A, H
4267	R-ALPHA LIPOIC ACID	A
4268	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%.
4269	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.
4270	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%.
4271	RANUNCULUS BULBOSUS	A, H
4272	RANUNCULUS FICARIA	A, H
4273	RANUNCULUS TERNATUS	A, H
4274	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%.
4275	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.
4276	RASPBERRY	E
4277	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%.
4278	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%.
4279	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%.
4280	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%.
4281	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%.
4282	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%.
4283	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%.
4284	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%.
4285	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%.
4286	RED ANT	H	Only for use as an active homoeopathic ingredient.
4287	RED CLOVER FLOWER DRY	A, H
4288	RED CLOVER FLOWER POWDER	A, H
4289	RED CORAL	H	Only for use as an active homoeopathic ingredient.
4290	RED DEER	A
4291	RED MERCURIC IODIDE	H	Only for use as an active homoeopathic ingredient.
4292	RED MERCURIC OXIDE	H	Only for use as an active homoeopathic ingredient.
4293	RED MERCURIC SULFIDE	H	Only for use as an active homoeopathic ingredient.
4294	REFINED BUGLOSSOIDES ARVENSIS SEED OIL	A	Only to be used in a medicine where Phytolove Pty Ltd (Client ID 80651), 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 3 July 2025. 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'.
4295	REHMANNIA GLUTINOSA	A, E, H
4296	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%.
4297	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%.
4298	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%.
4299	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’.
4300	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.’
4301	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.’
4302	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.’
4303	REYNOUTRIA JAPONICA	A, E, H	When used as an excipient, only for use in topical medicines for dermal application.
4304	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%.
4305	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'.
4306	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'.
4307	RHATANY ROOT DRY	A, H
4308	RHATANY ROOT POWDER	A, H
4309	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'.
4310	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’.
4311	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'.
4312	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'.
4313	RHODAMINE B	E	Permitted for use only as a colour for topical use.
4314	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%.
4315	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%.
4316	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.
4317	RHODODENDRON AUREUM	A, H
4318	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%.
4319	RHODODENDRON GROENLANDICUM	A, H
4320	RHODODENDRON MOLLE	A, H	The maximum recommended daily dose of the medicine must be no more than 1mg of the dry herbal material.
4321	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'.
4322	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'.
4323	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'.
4324	RHUS AROMATICA	A, E, H
4325	RHUS CHINENSIS	A, H
4326	RHUS GLABRA	A, E, H
4327	RHUS VENENATA	H	Only for use as an active homoeopathic ingredient.
4328	RIBES GROSSULARIA	A, E, H
4329	RIBES NIGRUM	A, E, H
4330	RIBOFLAVIN	A, E
4331	RIBOFLAVIN SODIUM PHOSPHATE	A, E
4332	RIBOFLAVIN TETRAACETATE	E	Only for use in topical medicines for dermal application.
4333	RIBOFLAVINE	A, E
4334	RIBOFLAVINE SODIUM PHOSPHATE	A, E
4335	RIBONUCLEIC ACID	E	Only for use in topical medicines for dermal application.
4336	RIBOSE	A	Only for use in oral medicines.
4337	RICE	E
4338	RICE BRAN	E
4339	RICE BRAN OIL	E
4340	RICE BRAN WAX	A, E, H
4341	RICE STARCH	E
4342	RICE VINEGAR	E
4343	RICE WINE	E	Ethanol is a mandatory component of rice wine.
4344	RICINOLEIC ACID	E	Only for use in topical medicines for dermal application.
4345	RICINUS COMMUNIS	A, H	Only for use when the plant part must be seed and the plant preparation is oil fixed.
4346	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.
4347	ROHDEA JAPONICA	A, H	The maximum recommended daily dose must be no more than the equivalent of 1mg of the dry herbal material.
4348	ROSA ARVENSIS	A, E, H
4349	ROSA CANINA	A, E, H
4350	ROSA CYMOSA	A, E, H
4351	ROSA EGLANTERIA	A, E, H
4352	ROSA GALLICA	A, E, H
4353	ROSA LAEVIGATA	A, E, H
4354	ROSA MULTIFLORA	A, E, H
4355	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%.
4356	ROSA RUGOSA	A, E, H
4357	ROSA VILLOSA	A, E, H
4358	ROSA X CENTIFOLIA	A, E, H
4359	ROSA X DAMASCENA	A, E, H
4360	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%.
4361	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%.
4362	ROSE FRUIT FRESH	A, E, H
4363	ROSE HIP	E
4364	ROSE OIL	A, E, H
4365	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%.
4366	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%.
4367	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'.
4368	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'.
4369	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'.
4370	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'.
4371	RUBBER NATURAL	E	Only for use in topical medicines for dermal application.
4372	RUBIA CORDIFOLIA	A, H
4373	RUBIA TINCTORUM	A, H
4374	RUBUS CHINGII	A, H
4375	RUBUS CORCHORIFOLIUS	A, H
4376	RUBUS COREANUS	A, E, H
4377	RUBUS FRUTICOSUS	A, E, H
4378	RUBUS IDAEUS	A, E, H
4379	RUBUS OCCIDENTALIS	A, E, H
4380	RUBUS PARVIFOLIUS	A, H
4381	RUBUS ROSIFOLIUS	A, H
4382	RUDBECKIA HIRTA	A, H
4383	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: - (NEW) ‘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%.
4384	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%.
4385	RUMEX ACETOSA	A, H
4386	RUMEX ACETOSELLA	A, H
4387	RUMEX CONGLOMERATUS	A, H
4388	RUMEX CRISPUS	A, E, H
4389	RUMEX PULCHER	A, H
4390	RUMEX SCUTATUS	A, H
4391	RUSCUS ACULEATUS	A, H
4392	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: - (NEW) ‘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%.
4393	RUTOSIDE	A, E
4394	RUTOSIDE TRIHYDRATE	A, E
4395	RYE	E	Gluten is a mandatory component of Rye when the route of administration is other than topical and mucosal.
4396	RYE BRAN	E	Gluten is a mandatory component of Rye bran when the route of administration is other than topical and mucosal.
4397	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%.
4398	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.
4399	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%.
4400	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%.
4401	SACCHARIN	E
4402	SACCHARIN SODIUM	E
4403	SACCHAROMYCES CEREVISIAE	A, E	When for topical use, the concentration in the medicine must be no more than 1%.
4404	SACCHAROMYCES CEREVISIAE (BOULARDII)	A
4405	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%.
4406	SACCHAROMYCES/ZINC FERMENT	E	Only for use in topical medicines for dermal application.
4407	SACCHARUM OFFICINARUM	A, E, H
4408	SAFFLOWER OIL	A, E, H
4409	SAFFRON	E	Permitted for use only as a colour for either topical use or with an oral route of administration.
4410	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%.
4411	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%.
4412	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’
4413	SAGE OIL SPANISH	A, E, H
4414	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%.
4415	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%.
4416	SALICYLIC ACID	E, H	Only for use in topical medicines for dermal application. The concentration in the medicine must be no more than 40%.
4417	SALIX ALBA	A, E, H
4418	SALIX DAPHNOIDES	A, H
4419	SALIX DISCOLOR	A, H
4420	SALIX FRAGILIS	A, H
4421	SALIX NIGRA	A, H
4422	SALIX PURPUREA	A, H
4423	SALSOLA KALI	A, H
4424	SALVIA CHINENSIS	A, H
4425	SALVIA FRUTICOSA	A, H
4426	SALVIA HISPANICA	A, E, H
4427	SALVIA LAVANDULAEFOLIA	A, H
4428	SALVIA MILTIORRHIZA	A, H
4429	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%.
4430	SALVIA SCLAREA	A, E, H
4431	SAMBUCUS CANADENSIS	A, H
4432	SAMBUCUS EBULUS	A, H
4433	SAMBUCUS NIGRA	A, E, H
4434	SANDALWOOD OIL EAST INDIAN	A, E, H
4435	SANGUINARIA CANADENSIS	H	Only for use as an active homoeopathic ingredient. The potency must be more than 4X.
4436	SANICULA EUROPAEA	A, H
4437	SANTALUM ALBUM	A, E, H
4438	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.
4439	SAPINDUS MUKOROSSI	A, H
4440	SAPONARIA OFFICINALIS	A, H
4441	SAPOSHNIKOVIA DIVARICATA	A, H
4442	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%.
4443	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.
4444	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.
4445	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%.
4446	SATUREIA HORTENSIS	A, H
4447	SATUREIA MONTANA	A, H
4448	SAUROPUS SPATULIFOLIUS	A, H
4449	SAURURUS CHINENSIS	A, H
4450	SAUSSUREA COSTUS	A, H
4451	SAVORY OIL SUMMER	A, H
4452	SAXIFRAGA GRANULATA	A, E, H
4453	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%.
4454	SCAPHIUM SCAPHIGERUM	A, H
4455	SCHEFFLERA HEPTAPHYLLA	A, H
4456	SCHINOPSIS QUEBRACHO-COLORADO	A, H
4457	SCHINUS MOLLE	A, H
4458	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%.
4459	SCHISANDRA CHINENSIS	A, E, H
4460	SCHIZONEPETA TENUIFOLIA	A, E, H
4461	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%.
4462	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%.
4463	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%.
4464	SCLERANTHUS ANNUUS	A, H
4465	SCLEROTIUM GUM	E	Only for use in topical medicines for dermal application.
4466	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%.
4467	SCROPHULARIA NINGPOENSIS	A, H
4468	SCROPHULARIA NODOSA	A, H
4469	SCURRULA PARASITICA VAR. GRACILIFLORA	A, H
4470	SCUTELLARIA BAICALENSIS	A, E, H
4471	SCUTELLARIA BARBATA	A, H
4472	SCUTELLARIA LATERIFLORA	A, E, H
4473	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%.
4474	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%.
4475	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%.
4476	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.
4477	SEDUM ACRE	A, H
4478	SELAGINELLA TAMARISCINA	A, H
4479	SELENICEREUS GRANDIFLORUS	A, E, H
4480	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.'
4481	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.'
4482	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.’
4483	SELF-EMULSIFYING GLYCERYL MONOSTEARATE	E
4484	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.
4485	SEMOLINA	E
4486	SEMPERVIVUM TECTORUM	A, H
4487	SENEGA ROOT DRY	A, H
4488	SENEGA ROOT POWDER	A, H
4489	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'.
4490	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'.
4491	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'.
4492	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'.
4493	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'.
4494	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'.
4495	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'.
4496	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'.
4497	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'.
4498	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’.
4499	SEQUOIA SEMPERVIRENS	A, H
4500	SEQUOIADENDRON GIGANTEUM	A, H
4501	SERENOA REPENS	A, H
4502	SERINE	A, E
4503	SERUM ANGUILLAE	H	Only for use as an active homoeopathic ingredient.
4504	SESAME OIL	A, E, H
4505	SESAMUM INDICUM	A, E, H
4506	SETARIA ITALICA	A, H
4507	SHARK CALCIUM CHONDROITIN SULFATE	A
4508	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)
4509	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%.
4510	SHARK POTASSIUM CHONDROITIN SULFATE	A
4511	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%.
4512	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.’
4513	SHEA BUTTER	E
4514	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%.
4515	SHEA BUTTER UNSAPONIFIABLES	E	Only for use in topical medicines for dermal application.
4516	SHELLAC	E
4517	SHEPHERD'S PURSE HERB DRY	A, H
4518	SHEPHERD'S PURSE HERB POWDER	A, H
4519	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%.
4520	SIGESBECKIA ORIENTALIS	A, E, H
4521	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%.
4522	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%.
4523	SILICA SILYLATE	E	Only for use in topical medicines for dermal application.
4524	SILICIFIED MICROCRYSTALLINE CELLULOSE	E	Only for use when the route of administration is other than inhalation.
4525	SILICON DIOXIDE	A, E, H	Only for use when the route of administration is other than inhalation.
4526	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).
4527	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).
4528	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%.
4529	SILVER NITRATE	H	Only for use as an active homoeopathic ingredient.
4530	SILYBUM MARIANUM	A, E, H
4531	SIMABA CEDRON	A, H
4532	SIMETHICONE	E
4533	SIMMONDSIA CHINENSIS	A, E, H
4534	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%.
4535	SINAPIS ARVENSIS	A, H
4536	SINOMENIUM ACUTUM	A, H
4537	SIPHONESTEGIA CHINENSIS	A, H
4538	SIRAITIA GROSVENORII	A, E, H
4539	SISYMBRIUM OFFICINALE	A, H
4540	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%.
4541	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.’
4542	SLIPPERY ELM BARK DRY	A, H
4543	SLIPPERY ELM BARK POWDER	A, E, H
4544	SMILAX ARISTOLOCHIIFOLIA	A, H
4545	SMILAX CHINA	A, H
4546	SMILAX GLABRA	A, H
4547	SMILAX OFFICINALIS	A, E, H
4548	SMILAX ORNATA	A, E, H
4549	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%.
4550	SODIUM ACETATE	E
4551	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%.
4552	SODIUM ACID CITRATE	A, E, H	When sodium acid citrate is used as an active ingredient, only for use in oral medicines.
4553	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%.
4554	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).
4555	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).
4556	SODIUM ALGINATE	E
4557	SODIUM ASCORBATE	A, E, H
4558	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%.
4559	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%.
4560	SODIUM BENZOATE	E
4561	SODIUM BETA-HYDROXY-BETA-METHYLBUTYRATE	A, H
4562	SODIUM BETA-HYDROXY-BETA-METHYLBUTYRATE MONOHYDRATE	A, H
4563	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.'
4564	SODIUM BISULFITE	E
4565	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%.
4566	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’.
4567	SODIUM C14-16 OLEFIN SULFONATE	E	Only for use in topical medicines for dermal application.
4568	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.
4569	SODIUM CARBOMER	E	Only for use as an excipient in topical medicines for dermal application.
4570	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.
4571	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.
4572	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%.
4573	SODIUM CARRAGEENAN	E
4574	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%.
4575	SODIUM CETOSTEARYL SULFATE	E	Only for use in topical medicines for dermal application.
4576	SODIUM CHLORIDE	A, E, H
4577	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).
4578	SODIUM CITRATE	A, E	When for use as an active ingredient, only for oral use.
4579	SODIUM CITRATE DIHYDRATE	A, E	When for use as an active ingredient, only for oral use.
4580	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%.
4581	SODIUM COCOAMPHOACETATE	E	Only for use in topical medicines for dermal application.
4582	SODIUM COCOYL SARCOSINATE	E	Only for use in topical medicines for dermal application.
4583	SODIUM CYCLAMATE	E
4584	SODIUM DEHYDROACETATE	E	Only for use in topical medicines for dermal application.
4585	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%.
4586	SODIUM DODECYLBENZENESULFONATE	E	Only for use in topical medicines for dermal application. The concentration in the medicine must be no more than 30%.
4587	SODIUM ERYTHORBATE	E
4588	SODIUM ETHYL HYDROXYBENZOATE	E
4589	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.'
4590	SODIUM FUMARATE	E
4591	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'.
4592	SODIUM HYDROGENATED TALLOW GLUTAMATE	E	Only for use in topical medicines for dermal application.
4593	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.
4594	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: ‘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.
4595	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%.
4596	SODIUM HYDROXYMETHYLGLYCINATE	E	Only for use in topical medicines for dermal application.
4597	SODIUM HYPOCHLORITE	E	The pH of the sodium hypochlorite preparation must be less than 11.5.
4598	SODIUM ISOSTEAROYL LACTYLATE	E	Only for use in topical medicines for dermal application.
4599	SODIUM LACTATE	E
4600	SODIUM LAURETH SULFATE	E
4601	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%.
4602	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%.
4603	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%.
4604	SODIUM LAUROYL SARCOSINATE	E	Only for use in topical medicines for dermal application.
4605	SODIUM LAURYL PHOSPHATE	E
4606	SODIUM LAURYL SULFATE	E
4607	SODIUM LAURYL SULFOACETATE	E	Only for use in topical medicines for dermal application.
4608	SODIUM MAGNESIUM SILICATE	E	Only for use in topical medicines for dermal application.
4609	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%.
4610	SODIUM METABISULFITE	E
4611	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%.
4612	SODIUM METHYL COCOYL TAURATE	E	Only for dental use. The concentration in the medicine must be no more than 2%.
4613	SODIUM METHYL HYDROXYBENZOATE	E
4614	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.
4615	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.'
4616	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%.
4617	SODIUM NITRATE	H	Only for use as an active homoeopathic ingredient.
4618	SODIUM NONOXYNOL-4 SULFATE	E	Only for use in topical medicines for dermal application.
4619	SODIUM PANTOTHENATE	A, E, H
4620	SODIUM PCA	E	Only for use in topical medicines for dermal application.
4621	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).
4622	SODIUM PERCARBONATE	E	Only for use in topical medicines for dermal application. The concentration in the medicine must be no more than 15%.
4623	SODIUM POLYACRYLATE	E	Only for use in topical medicines for dermal application.
4624	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%.
4625	SODIUM POLYMETAPHOSPHATE	E
4626	SODIUM PROPIONATE	E
4627	SODIUM PROPYL HYDROXYBENZOATE	E
4628	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%.
4629	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.'
4630	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.'
4631	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.’
4632	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.’
4633	SODIUM SILICATE	E
4634	SODIUM STARCH GLYCOLLATE	E
4635	SODIUM STARCH GLYCOLLATE TYPE A	E
4636	SODIUM STEARATE	E	Only for use in topical medicines for dermal application.
4637	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%.
4638	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%.
4639	SODIUM STEAROYL LACTYLATE	E	Only for use in topical medicines for dermal application.
4640	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%.
4641	SODIUM SUCCINATE	E	Only for use in topical medicines for dermal application.
4642	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'.
4643	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'.
4644	SODIUM SULFITE	E
4645	SODIUM SULFITE HEPTAHYDRATE	E	Only for use in topical medicines for dermal application.
4646	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%.
4647	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.
4648	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.
4649	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%.
4650	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.
4651	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.
4652	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.
4653	SOLIDAGO GIGANTEA	A, H
4654	SOLIDAGO GIGANTEA MIS	A, E, H
4655	SOLIDAGO VIRGAUREA	A, E, H
4656	SOLUBLE MAIZE STARCH	E
4657	SOLUBLE POTATO STARCH	E
4658	SOLVENT GREEN 3	E	Permitted for use only as a colour for topical use.
4659	SOLVENT RED 1	E	Permitted for use only as a colour for topical use.
4660	SOLVENT VIOLET 13	E	Permitted for use only as a colour for topical use.
4661	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%.
4662	SOLVENT YELLOW 33	E	Permitted for use only as a colour for topical use.
4663	SOPHORA FLAVESCENS	A, E, H
4664	SOPHORA TONKINENSIS	A, H
4665	SORBIC ACID	E
4666	SORBITAN ISOSTEARATE	E	Only for use in topical medicines for dermal application.
4667	SORBITAN MONO-OLEATE	E
4668	SORBITAN MONOLAURATE	E
4669	SORBITAN MONOSTEARATE	E
4670	SORBITAN OLEATE	E
4671	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%.
4672	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%.
4673	SORBITAN SESQUIISOSTEARATE	E	Only for use in topical medicines for dermal application.
4674	SORBITAN SESQUIOLEATE	E	Only for use in topical medicines for dermal application.
4675	SORBITAN STEARATE	E
4676	SORBITAN TRISTEARATE	E	Only for use in topical medicines for dermal application.
4677	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.
4678	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.
4679	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.
4680	SORBUS AUCUPARIA	A, H
4681	SORGHUM	E
4682	SORGHUM VULGARE	A, H
4683	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.
4684	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.
4685	SOY POLYSACCHARIDE	E
4686	SOY PROTEIN	E
4687	SOY STEROL	E
4688	SOYA BEAN	E
4689	SOYA OIL	A, E, H
4690	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%.
4691	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%.
4692	SPARGANIUM STOLONIFERUM	A, H
4693	SPARTIUM JUNCEUM	A, H
4694	SPATHOLOBUS SUBERECTUS	A, H
4695	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.
4696	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.
4697	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%.
4698	SPIGELIA ANTHELMIA	A, H
4699	SPIGELIA MARILANDICA	A, H	The maximum recommended daily dose must be no more than the equivalent of 1mg of the dry herbal material.
4700	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.
4701	SPINACH	E
4702	SPINACIA OLERACEA	A, E, H
4703	SPIRODELA POLYRRHIZA	A, H
4704	SPIRULINA	E
4705	SPRAY-DRIED GLUCOSE SYRUP	E	Permitted for use as an excipient for oral routes of administration.
4706	SPRAY-DRIED LIQUID GLUCOSE	E	Permitted for use as an excipient for oral routes of administration.
4707	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%.
4708	SQUALANE	E	Only for use in topical medicines for dermal application.
4709	SQUALENE	A, E
4710	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’.
4711	SQUILL DRY	A, H
4712	SQUILL INDIAN DRY	A, H
4713	SQUILL INDIAN POWDER	A, H
4714	SQUILL POWDER	A, H
4715	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.'
4716	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.'
4717	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.'
4718	STACHYS OFFICINALIS	A, E, H
4719	STACHYS PALUSTRIS	A, H
4720	STACHYURUS HIMALAICUS	A, H
4721	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%.
4722	STANNOUS CHLORIDE	H	Only for use as an active homoeopathic ingredient.
4723	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).
4724	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%.
4725	STARCH SODIUM OCTENYL SUCCINATE	E
4726	STEARALKONIUM CHLORIDE	E	Only for use in topical medicines for dermal application.
4727	STEARALKONIUM HECTORITE	E	Only for use in topical medicines for dermal application.
4728	STEARAMIDE	E	Only for use in topical medicines for dermal application.
4729	STEARAMIDOETHYL DIETHYLAMINE	E	Only for use in topical medicines for dermal application.
4730	STEARAMIDOPROPYL DIMETHYLAMINE	E	Only for use in topical medicines for dermal application.
4731	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).
4732	STEARETH-10	E	Only for use in topical medicines for dermal application.
4733	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%.
4734	STEARETH-2	E	Only for use in topical medicines for dermal application.
4735	STEARETH-20	E	Only for use in topical medicines for dermal application.
4736	STEARETH-21	E	Only for use in topical medicines for dermal application.
4737	STEARETH-5	E	Only for use in topical medicines for dermal application.
4738	STEARIC ACID	E
4739	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%.
4740	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%.
4741	STEAROXYTRIMETHYLSILANE	E	Only for use in topical medicines for dermal application.
4742	STEAROYL MACROGOLGLYCERIDES	E	Only for use in oral medicines. The concentration in the medicine must be no more than 0.6%.
4743	STEARYL ACETATE	E	Only for use in topical medicines for dermal application.
4744	STEARYL ALCOHOL	E
4745	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.
4746	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).
4747	STEARYL GLYCYRRHETINATE	E	Only for use in topical medicines for dermal application.
4748	STEARYL HEPTANOATE	E	Only for use in topical medicines for dermal application.
4749	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%.
4750	STEARYL STEARATE	E	Only for use in topical medicines for dermal application.
4751	STELLARIA CHAMAEJASME	A, H
4752	STELLARIA DICHOTOMA	A, H
4753	STELLARIA MEDIA	A, E, H
4754	STEMONA JAPONICA	A, H
4755	STEMONA SESSILIFOLIA	A, H
4756	STENOTAPHRUM SECUNDATUM	A, H
4757	STEPHANIA TETRANDA	A, H
4758	STERCULIA	A, H
4759	STERCULIA TRAGACANTHA	A, H
4760	STERCULIA URENS	A, H
4761	STEVIA REBAUDIANA	A, E, H
4762	STEVIOL GLYCOSIDES	E	Only for use in oral medicines.
4763	STILLINGIA SYLVATICA	A, H
4764	STORAX PREPARED	A, E, H
4765	STRAWBERRY	E
4766	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%.
4767	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'.
4768	STREPTOCOCCUS THERMOPHILUS	A
4769	STROBILANTHES CUSIA	A, H
4770	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%.
4771	STRONTIUM CARBONATE	H	Only for use as an active homoeopathic ingredient.
4772	STROPHANTHUS GRATUS	H	Only for use as an active homoeopathic ingredient.
4773	STROPHANTHUS HISPIDUS	H	Only for use as an active homoeopathic ingredient.
4774	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%.
4775	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%.
4776	STYPHNOLOBIUM JAPONICUM	A, E, H
4777	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%.
4778	STYRAX BENZOIN	A, E, H
4779	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%.
4780	STYRAX PARALLELONEURUM	A, H
4781	STYRAX TONKINENSIS	A, H
4782	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%.
4783	STYRENE/ACRYLATES COPOLYMER	E	Only for use in topical medicines for dermal application.
4784	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%.
4785	SUBLIMED SULFUR	H	Only for use as an active homoeopathic ingredient.
4786	SUCCINIC ACID	E
4787	SUCRALOSE	E
4788	SUCROSE	E
4789	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%.
4790	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%.
4791	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%.
4792	SUCROSE DISTEARATE	E	Only for use in topical medicines for dermal application.
4793	SUCROSE LAURATE	E	When for oral or sublingual use, sucrose is a mandatory component of sucrose laurate.
4794	SUCROSE OCTAACETATE	E	When for oral or sublingual use, sucrose is a mandatory component of sucrose octaacetate.
4795	SUCROSE PALMITATE	E	Only for use in topical medicines for dermal application.
4796	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).
4797	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.
4798	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%.
4799	SUDAN III	E	Permitted for use only as a colour for topical use.
4800	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’.
4801	SUGARCANE	E, H	When for oral or sublingual use, sucrose is a mandatory component of sugarcane.
4802	SULFATED CASTOR OIL	E	Only for use in topical medicines for dermal application.
4803	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%.
4804	SULFUR DIOXIDE	E
4805	SULFUR IODIDE	H	Only for use as an active homoeopathic ingredient.
4806	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%.
4807	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%.
4808	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).
4809	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).
4810	SUNFLOWER OIL	A, E, H
4811	SUNFLOWER SEED	E, H
4812	SUNSET YELLOW FCF	E	Permitted for use only as a colour for either topical use or with an oral route of administration.
4813	SUNSET YELLOW FCF ALUMINIUM LAKE	E	Permitted for use only as a colour in medicines limited to topical and oral routes of administration.
4814	SUPEROXIDE DISMUTASE	E	Only for use in topical medicines for dermal application.
4815	SWEDE	E
4816	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%.
4817	SWEET POTATO	E
4818	SWERTIA CHIRATA	A, H
4819	SWIETENIA MAHOGANI	A, H
4820	SYAGRUS ROMANZOFFIANA	A, E, H
4821	SYMPHYOTRICHUM NOVI-BELGII	A, H
4822	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%.
4823	SYMPLOCARPUS FOETIDUS	A, H
4824	SYNTHETIC BEESWAX	E	Only for use in topical medicines for dermal applications.
4825	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.
4826	SYNTHETIC WAX	E
4827	SYRINGA RETICULATA	A, H
4828	SYRINGA VULGARIS	A, H
4829	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%.
4830	SYZYGIUM CUMINI	A, H
4831	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%.
4832	TABEBUIA SERRATIFOLIA	A, E, H
4833	TADEHAGI TRIQUETRUM	A, H
4834	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%.
4835	TAGETES MINUTA	A, E, H
4836	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%.
4837	TAIPAN SNAKE	H	Only for use as an active homoeopathic ingredient.
4838	TALLOW	E	Only for use in topical medicines for dermal application.
4839	TALLOW GLYCERIDES	E
4840	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%.
4841	TAMARIX APHYLLA	A, H
4842	TAMARIX CHINENSIS	A, H
4843	TAMARIX GALLICA	A, H
4844	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.
4845	TANACETUM CINERARIIFOLIUM	A, H	The concentration in the medicine must be no more than 10%.
4846	TANACETUM COCCINEUM SUBSP. COCCINEUM	A, H
4847	TANACETUM PARTHENIUM	A, E, H
4848	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%.
4849	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%.
4850	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.
4851	TANNIC ACID	E
4852	TAPIOCA STARCH	E
4853	TARAXACUM MONGOLICUM	A, E, H
4854	TARAXACUM OFFICINALE	A, E, H
4855	TARO	E
4856	TARRAGON OIL	A, E, H
4857	TARTARIC ACID	E
4858	TARTRAZINE	E	Only for use as a colour. Only for use in medicines for topical and oral administration.
4859	TARTRAZINE ALUMINIUM LAKE	E	Only for use as a colour. Only for use in medicines for topical and oral administration.
4860	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%.
4861	TAURINE	A, E
4862	TEA-STEARATE	E	Only for use in topical medicines for dermal application.
4863	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'.
4864	TERMINALIA BELLIRICA	A	Only for use when the preparation is as an aqueous extract of the fruit pericarp.
4865	TERMINALIA CATAPPA	A, H
4866	TERMINALIA CHEBULA	A, H
4867	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%.
4868	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%.
4869	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.
4870	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%.
4871	TERPINEOL	E
4872	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%.
4873	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%.
4874	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%.
4875	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%.
4876	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%.
4877	TERT-BUTYL ALCOHOL	E	Only for use in topical medicines for dermal application.
4878	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%.
4879	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%.
4880	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%.
4881	TETRACLINIS ARTICULATA	A, E, H
4882	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%.
4883	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.
4884	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%.
4885	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%.
4886	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%.
4887	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%.
4888	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%.
4889	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%.
4890	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%.
4891	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%.
4892	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%.
4893	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%.
4894	TETRAHYDROXYPROPYL ETHYLENEDIAMINE	E	Only for use in topical medicines for dermal application.
4895	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%.
4896	TETRAPANAX PAPYRIFER	A, H
4897	TETRASODIUM ETIDRONATE	E	Only for use in topical medicines for dermal application.
4898	TETRASODIUM PYROPHOSPHATE	E
4899	TEUCRIUM CHAMAEDRYS	A, H	The maximum recommended daily dose must be no more than 1mg of the equivalent dry herbal material of Teucrium chamaedrys.
4900	TEUCRIUM MARUM	A, H	The maximum recommended daily dose must be no more than 1mg of the equivalent dry herbal material of Teucrium marum.
4901	TEUCRIUM SCORODONIA	A, H	The maximum recommended daily dose must be no more than 1mg of the equivalent dry herbal material of Teucrium scorodonia.
4902	THAPSIA GARGANICA	A, H
4903	THAUMATIN	E
4904	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'.
4905	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%.
4906	THEMEDA TRIANDRA	A, H
4907	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).
4908	THEOBROMA OIL	A, E, H
4909	THIAMINE	A, E
4910	THIAMINE HYDROCHLORIDE	A, E
4911	THIAMINE NITRATE	A, E
4912	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%.
4913	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%.
4914	THLASPI ARVENSE	A, E, H
4915	THREONINE	A, E
4916	THUJA OCCIDENTALIS	A, H
4917	THUJA PLICATA	A, E, H
4918	THYME HERB DRY	A, E, H
4919	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).
4920	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.
4921	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.
4922	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).
4923	THYMUS GLAND	H	Only for use as an active homoeopathic ingredient.
4924	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).
4925	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).
4926	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).
4927	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).
4928	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).
4929	TIGER SNAKE	H	Only for use as an active homoeopathic ingredient.
4930	TILACTASE	A	Must be derived from Aspergillus oryzae and comply with the relevant USP monograph.
4931	TILIA CORDATA	A, E, H
4932	TILIA PLATYPHYLLOS	A, E, H
4933	TILIA TOMENTOSA	A, H
4934	TILIA X VULGARIS	A, E, H
4935	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%.
4936	TIN	H	Only for use as an active homoeopathic ingredient.
4937	TINOSPORA CORDIFOLIA	A, H
4938	TINOSPORA SINENSIS	A, H
4939	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).
4940	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%.
4941	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%
4942	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%.
4943	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%
4944	TOCOPHERYL LINOLEATE	E	Only for use in topical medicines for dermal application.
4945	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%.
4946	TOLU BALSAM	A, E, H
4947	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%.
4948	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%.
4949	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%.
4950	TOMATO	E
4951	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%.
4952	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%.
4953	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%.
4954	TOXICODENDRON DIVERSILOBUM	H	Only for use as an active homoeopathic ingredient.
4955	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.
4956	TOXICODENDRON RADICANS	A, H	The maximum recommended daily dose must be no more than 1mg of the equivalent dry herbal material of Toxicodendron radicans.
4957	TOXICODENDRON SUCCEDANEUM	H	Only for use as an active homoeopathic ingredient.
4958	TRACHELOSPERMUM JASMINOIDES	A, E, H
4959	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%.
4960	TRAGACANTH	A, E
4961	TRAMETES VERSICOLOR	A, H
4962	TRAMETES VERSICOLOR PROTEOGLYCAN CONCENTRATE	A, H	Only for use in oral medicines.
4963	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%.
4964	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.
4965	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%.
4966	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%.
4967	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%.
4968	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%.
4969	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%.
4970	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%.
4971	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%.
4972	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%.
4973	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%.
4974	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%.
4975	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.
4976	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%.
4977	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%.
4978	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%.
4979	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%.
4980	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%.
4981	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%.
4982	TREACLE	E	When for oral or sublingual use, sucrose is a mandatory component of treacle.
4983	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%.
4984	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.
4985	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.
4986	TREMELLA FUCIFORMIS	A, H
4987	TRIACETIN	E
4988	TRIACONTANYL PVP	E	Only for use in topical medicines for dermal application.
4989	TRIADICA SEBIFERA	A, H
4990	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.
4991	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.
4992	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%.
4993	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%.
4994	TRIBULUS TERRESTRIS	A, E, H
4995	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%.
4996	TRICALCIUM PHOSPHATE	E
4997	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%.
4998	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%.
4999	TRICETEARETH-4 PHOSPHATE	E	Only for use in topical medicines for dermal application.
5000	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%.
5001	TRICHODERMA VIRIDE	A, E, H
5002	TRICHOSANTHES KIRILOWII	A, E, H
5003	TRICLOSAN	E	The concentration in the medicine must be no more than 1%.
5004	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%.
5005	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%.
5006	TRIDECETH-4 PHOSPHATE	E	Only for use in topical medicines for dermal application.
5007	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%.
5008	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%.
5009	TRIDECYL BEHENATE	E	Behenic acid is a mandatory component of Tridecyl behenate. Only for use in topical medicines for dermal application.
5010	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%.
5011	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%.
5012	TRIDECYL STEARATE	E	Only for use in topical medicines for dermal application.
5013	TRIDECYL TRIMELLITATE	E	Only for use in topical medicines for dermal application.
5014	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%.
5015	TRIETHYL CITRATE	E
5016	TRIETHYLENE GLYCOL	E
5017	TRIFOLIUM PRATENSE	A, E, H
5018	TRIFOLIUM REPENS	A, H
5019	TRIGONELLA FOENUM-GRAECUM	A, E, H
5020	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%.
5021	TRIHYDROXYSTEARIN	E	Only for use in topical medicines for dermal application.
5022	TRIISOCETYL CITRATE	E	Only for use in topical medicines for dermal application.
5023	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%.
5024	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%.
5025	TRIISOSTEARIN	E	Only for use in topical medicines for dermal application.
5026	TRILAURIN	E	Only for use in topical medicines for dermal application.
5027	TRILISA ODORATISSIMA	A, H
5028	TRILLIUM ERECTUM	A, H
5029	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%.
5030	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%.
5031	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%.
5032	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%.
5033	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%.
5034	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%.
5035	TRIMETHYLOPROPANE TRIOCTANOATE	E	Only for use in topical medicines for dermal application.
5036	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%.
5037	TRIMETHYLSILOXYSILICATE	E	Only for use in topical medicines for dermal application.
5038	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%.
5039	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%.
5040	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%.
5041	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%.
5042	TRIOSTEUM PERFOLIATUM	A, H
5043	TRIOXAUNDECANEDIOIC ACID	E
5044	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%.
5045	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).
5046	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%.
5047	TRISODIUM EDETATE	E	Only for use in topical medicines for dermal application.
5048	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%.
5049	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%.
5050	TRISTEARIN	E
5051	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.
5052	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.
5053	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%.
5054	TROLAMINE	E	Only for use in topical medicines for dermal application. The concentration in the medicine must be no more than 5%.
5055	TROLAMINE LAURIL SULFATE	E	Only for use in topical medicines for dermal application.
5056	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).
5057	TROLLIUS CHINENSIS	A, H
5058	TROMETAMOL	E
5059	TROMETAMOL HYDROCHLORIDE	E
5060	TROPAEOLUM MAJUS	A, E, H
5061	TROPICAL RATTLESNAKE	H	Only for use as an active homoeopathic ingredient.
5062	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%.
5063	TSUGA CANADENSIS	A, H
5064	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%.
5065	TURMERIC	E	Permitted for use only in combination with other permitted ingredients as a colour.
5066	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%.
5067	TURNIP	E
5068	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%.
5069	TYPHA ANGUSTIFOLIA	A, H
5070	TYPHA LATIFOLIA	A, H
5071	TYPHONIUM GIGANTEUM	A, H
5072	TYROSINE	A, E