Permissible ingredients and requirements |
Column 1 | Column 2 | Column 3 | Column 4 |
Item | Ingredient name | Purpose | Specific requirements |
3614 | 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%. |
3615 | 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%. |
3616 | 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 be no more than 8%. When used in primary sunscreen products and listed in the Register on or after 1 January 2018, the medicine must have the following statements on the medicine 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). When used in primary sunscreen products and listed in the Register before 1 January 2018, the medicine requires the following statements on the medicine label if supplied after 1 July 2019: - (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). |
3617 | 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%. |
3618 | PAEONIA LACTIFLORA | A, E, H | |
3619 | PAEONIA OBOVATA | A, H | |
3620 | PAEONIA SUFFRUTICOSA | A, E, H | |
3621 | PAEONIA VEITCHII | A, H | |
3622 | PALIURUS SPINA-CHRISTI | A, H | |
3623 | PALLADIUM | H | Only for use as an active homoeopathic ingredient. |
3624 | PALM FRUIT OIL | A, E, H | |
3625 | PALM GLYCERIDES | E | |
3626 | PALM KERNEL OIL | A, E, H | |
3627 | PALM TOCOTRIENOLS COMPLEX | A, H | |
3628 | PALMARIA PALMATA | A, H | |
3629 | PALMAROSA OIL | A, E, H | |
3630 | PALMIDROL | A | Only to be used in a medicine where Pharmako Biotechnologies Pty Ltd (Client ID 62358), 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 02 December 2021. Only permitted for use in medicines limited to oral routes of administration. The maximum recommended daily dose of the medicine must not contain more than 600mg of palmidrol. The following warning statements are required on the medicine label: - 'The medicine may interact with other prescription analgesic medicines, please consult your healthcare practitioner before use' (or words to that effect). - (ADULT) ‘Adults only’ (or words to that effect) - ‘Not to be used for more than 21 consecutive days’ (or words to that effect). |
3631 | PALMITIC ACID | E | |
3632 | PALMITOLEIC ACID-RICH FATTY ACID ETHYL ESTERS | A | |
3633 | 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%. |
3634 | 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% |
3635 | 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%. |
3636 | 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%. |
3637 | 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%. |
3638 | PANAX GINSENG | A, E, H | |
3639 | PANAX JAPONICUS | A, H | |
3640 | PANAX NOTOGINSENG | A, H | |
3641 | PANAX PSEUDOGINSENG | A, H | |
3642 | PANAX QUINQUEFOLIUS | A, H | |
3643 | PANICUM MILIACEUM | A, H | |
3644 | PANTETHINE | E | Only for use in topical medicines for dermal application. |
3645 | PANTHENOL | A, E | |
3646 | PANTHENYL ETHYL ETHER | E | Only for use in topical medicines for dermal application. |
3647 | PANTOLACTONE | E | |
3648 | PANTOTHENIC ACID | A, E | When used topically, the concentration in the medicine must be no more than 0.1%. |
3649 | 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%. |
3650 | PAPAIN | A, E | |
3651 | PAPER | E | Only for use in topical medicines for dermal application. |
3652 | 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%. |
3653 | 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%. |
3654 | 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%. |
3655 | 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%. |
3656 | 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%. |
3657 | 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%. |
3658 | 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%. |
3659 | 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%. |
3660 | 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%. |
3661 | PARA-HYDROXYBENZOIC ACID | E | |
3662 | 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%. |
3663 | 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%. |
3664 | 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%. |
3665 | 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%. |
3666 | PARA-PROPYL 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%. |
3667 | 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%. |
3668 | 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%. |
3669 | 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%. |
3670 | 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%. |
3671 | PARAMERIA LAEVIGATA | A, H | |
3672 | PARIETARIA JUDAICA | A, H | |
3673 | PARIS POLYPHYLLA | A, H | |
3674 | PARIS QUADRIFOLIA | A, H | |
3675 | PARSLEY | E, H | |
3676 | PARSLEY HERB DRY | A, E, H | |
3677 | PARSLEY HERB OIL | A, E, H | |
3678 | PARSLEY HERB POWDER | A, E, H | |
3679 | PARSLEY SEED OIL | A, E, H | |
3680 | PARTHENOCISSUS TRICUSPIDATA | A, H | |
3681 | 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%. |
3682 | 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%. |
3683 | PASPALUM NOTATUM | A, H | |
3684 | PASSIFLORA CAERULEA | A, H | |
3685 | PASSIFLORA EDULIS | E | |
3686 | PASSIFLORA HERB DRY | A, H | |
3687 | PASSIFLORA INCARNATA | A, E, H | |
3688 | 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%. |
3689 | PATENT BLUE V | E | Permitted for use only as a colour for oral and topical use. |
3690 | PATENT BLUE V ALUMINIUM LAKE | E | Permitted for use only as a colour for oral and topical use. |
3691 | PATRINIA SCABIOSIFOLIA | A, H | |
3692 | PATRINIA VILLOSA | A, H | |
3693 | PAULLINIA CUPANA | A, E, H | Caffeine is a mandatory component of Paullinia cupana. 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 4%. 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%. The requirements specified in paragraphs (a) to (e) below apply in relation to a medicine that contains the ingredient that: - is listed in the Register on or after 2 September 2019; or - is supplied after 2 March 2021. A medicine that contains the ingredient and that: - was listed in the Register before 2 September 2019; and - is supplied before 2 March 2021; may comply with the requirements in paragraphs (a) to (e) below. a) When for internal use or oral application, the maximum recommended daily dose of the medicine must provide no more than 400mg of total caffeine. b) 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%. c) 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. d) 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.’ e) 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). |
3694 | PAULLINIA PINNATA | A, H | |
3695 | PAWPAW | E | |
3696 | PEA | E | |
3697 | PEA STARCH | E | |
3698 | PEACH | E | |
3699 | PEANUT | E | The medicine requires the following warning statement on the medicine label: - (PEANUT) ‘Contains Peanut’ (or words to that effect). |
3700 | PEAR | E | |
3701 | PECAN | E | |
3702 | PECTIN | A, E | |
3703 | 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%. |
3704 | PEG-10 SOYA STEROL | E | Only for use in topical medicines for dermal application. |
3705 | PEG-100 STEARATE | E | Only for use in topical medicines for dermal application. |
3706 | PEG-12 DILAURATE | E | |
3707 | 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%. |
3708 | PEG-120 METHYL GLUCOSE DIOLEATE | E | Only for use in topical medicines for dermal application. |
3709 | PEG-120 STEARATE | E | Only for use in topical medicines for dermal application. |
3710 | PEG-15 COCAMINE | E | Only for use in topical medicines for dermal application. |
3711 | PEG-150 DISTEARATE | E | Only for use in topical medicines for dermal application. |
3712 | 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%. |
3713 | PEG-20 METHYL GLUCOSE DISTEARATE | E | Only for use in topical medicines for dermal application. |
3714 | PEG-20 METHYL GLUCOSE SESQUISTEARATE | E | Only for use in topical medicines for dermal application. |
3715 | PEG-20 SORBITAN ISOSTEARATE | E | Only for use in topical medicines for dermal application. |
3716 | PEG-20 STEARATE | E | Only for use in topical medicines for dermal application. |
3717 | 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 be no more than 10%. When used in primary sunscreen products and listed in the Register on or after 1 January 2018, the medicine must have the following statements on the medicine 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). When used in primary sunscreen products and listed in the Register before 1 January 2018, the medicine requires the following statements on the medicine label if supplied after 1 July 2019: - (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). |
3718 | PEG-30 DIPOLYHYDROXYSTEARATE | E | Only for use in topical medicines for dermal application. |
3719 | PEG-30 STEARATE | E | Only for use in topical medicines for dermal application. |
3720 | PEG-35 CASTOR OIL | E | |
3721 | PEG-4 DILAURATE | E | Only for use in topical medicines for dermal application. |
3722 | 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%. |
3723 | PEG-4 STEARATE | E | Only for use in topical medicines for dermal application. |
3724 | PEG-40 CASTOR OIL | E | |
3725 | PEG-40 HYDROGENATED CASTOR OIL | E | |
3726 | 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%. |
3727 | PEG-40 STEARATE | E | Only for use in topical medicines for dermal application. |
3728 | PEG-45/DODECYL GLYCOL COPOLYMER | E | Only for use in topical medicines for dermal application. |
3729 | PEG-5 GLYCERYL STEARATE | E | Only for use in topical medicines for dermal application. |
3730 | PEG-50 STEARATE | E | Only for use in topical medicines for dermal application. |
3731 | 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%. |
3732 | PEG-6 LAURAMIDE | E | Only for use in topical medicines for dermal application. |
3733 | 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%. |
3734 | 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%. |
3735 | PEG-60 HYDROGENATED CASTOR OIL | E | Only for use in topical medicines for dermal application. |
3736 | PEG-7 COCAMIDE | E | Only for use in topical medicines for dermal application. |
3737 | PEG-7 GLYCERYL COCOATE | E | Only for use in topical medicines for dermal application. |
3738 | PEG-7 HYDROGENATED CASTOR OIL | E | Only for use in topical medicines for dermal application. |
3739 | PEG-75 LANOLIN | E | Only for use in topical medicines for dermal application. |
3740 | 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%. |
3741 | 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%. |
3742 | 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%. |
3743 | PEG-8 DISTEARATE | E | Only for use in topical medicines for dermal application. |
3744 | 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. |
3745 | PEG-8 PROPYLENE GLYCOL COCOATE | E | |
3746 | PEG-8 STEARATE | E | Only for use in topical medicines for dermal application. |
3747 | 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%. |
3748 | 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%. |
3749 | 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%. |
3750 | PELARGONIUM GRAVEOLENS | A, E, H | |
3751 | 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%. |
3752 | PELTIGERA CANINA | A, H | |
3753 | PENICILLIUM EXPANSUM | A, H | |
3754 | 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. |
3755 | 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% |
3756 | 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%. |
3757 | PENTAERYTHRITYL TETRALAURATE | E | Only for use in topical medicines for dermal application. The concentration in the medicine must be no more than 80%. |
3758 | 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%. |
3759 | 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%. |
3760 | 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%. |
3761 | 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%. |
3762 | PEPPER BLACK | E, H | |
3763 | 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%. |
3764 | PEPPER WHITE | E, H | |
3765 | 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 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; - (EYE) Avoid contact with eyes (or words to that effect). d) 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. |
3766 | PEPPERMINT LEAF DRY | A, E, H | When the ingredient is included in a medicine that is listed in the Register: - on or after 1 July 2018, the medicine must comply with all requirements under (a)-(c); - before 1 July 2018 and supplied on or after 1 January 2020, the medicine must comply with all requirements under (a)-(c); or - before 1 July 2018 and supplied before 1 January 2020, the medicine may comply with requirements under (a)-(c). a) Menthol is a mandatory component of peppermint leaf dry. b) 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 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; - (EYE) Avoid contact with eyes (or words to that effect). (iv) 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. c) When the medicine is for internal use, the maximum recommended daily dose must not contain more than 1 gram of menthol. |
3767 | PEPPERMINT LEAF POWDER | A, E, H | When the ingredient is included in a medicine that is listed in the Register: - on or after 1 July 2018, the medicine must comply with all requirements under (a)-(c); - before 1 July 2018 and supplied on or after 1 January 2020, the medicine must comply with all requirements under (a)-(c); or - before 1 July 2018 and supplied before 1 January 2020, the medicine may comply with requirements under (a)-(c). a) Menthol is a mandatory component of peppermint leaf powder. b) 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 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; - (EYE) Avoid contact with eyes (or words to that effect). (iv) 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. c) When the medicine is for internal use, the maximum recommended daily dose must not contain more than 1 gram of menthol. |
3768 | PEPPERMINT OIL | A, E, H | When the ingredient is included in a medicine that is listed in the Register: - on or after 1 July 2018, the medicine must comply with all requirements under (a)-(c); - before 1 July 2018, and supplied on or after 1 January 2020 the medicine must comply with all requirements under (a)-(c); or - before 1 July 2018 and supplied before 1 January 2020, the medicine may comply with requirements under (a)-(c). a) Menthol is a mandatory component of peppermint oil. b) 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 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; - (EYE) Avoid contact with eyes (or words to that effect). (iv) 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. c) When the medicine is for internal use, the maximum recommended daily dose must not contain more than 1 gram of menthol. |
3769 | 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: 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 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; - (EYE) Avoid contact with eyes (or words to that effect). d) 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. |
3770 | 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: 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 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; - (EYE) Avoid contact with eyes (or words to that effect). d) 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. |
3771 | PERFLUOROPOLYMETHYLISOPROPYL ETHER | E | Only for use in topical medicines for dermal application. |
3772 | 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%. |
3773 | PERILLA FRUTESCENS | A, E, H | Rosmarinic acid and vicenin-2 are only permitted for use if the plant part of Perilla frutescens is leaf. |
3774 | 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%. |
3775 | 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%. |
3776 | PERMETHRIN | E | The concentration of in the medicine must be no more than 2%. |
3777 | PERSEA AMERICANA | A, E, H | |
3778 | PERSIC OIL | A, E, H | Amygdalin and Hydrocyanic acid are mandatory components of Persic oil. The concentration of amygdalin in the medicine must be no more than 0%. The concentration of Hydrocyanic acid in the medicine must be no more than 1 microgram/kg or 1 microgram/L or 0.0000001%. |
3779 | PERSICARIA CHINENSIS | A, H | |
3780 | PERSICARIA TINCTORIA | A, H | |
3781 | PERSIMMON | E | |
3782 | PERU BALSAM | A, E, H | |
3783 | PERU BALSAM OIL | A, E, H | |
3784 | 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% |
3785 | 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%. |
3786 | 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%. |
3787 | 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. |
3788 | 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%. |
3789 | PETROSELINUM CRISPUM | A, E, H | |
3790 | PEUCEDANUM PRAERUPTORUM | A, E, H | |
3791 | 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). |
3792 | PHALARIS ARUNDINACEA | A, H | |
3793 | PHALARIS CANARIENSIS | A, H | |
3794 | PHASEOLUS COCCINEUS | A, H | |
3795 | PHASEOLUS VULGARIS | A, H | |
3796 | PHELLINUS ROBINIAE | A, E, H | |
3797 | PHELLODENDRON AMURENSE | A, E, H | |
3798 | PHELLODENDRON CHINENSE | A, H | |
3799 | PHENACETIN | E | Only for use in topical medicines for dermal application. The concentration in the medicine must be no more than 0.1%. |
3800 | 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%. |
3801 | 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%. |
3802 | 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%. |
3803 | 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%. |
3804 | 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% |
3805 | 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%. |
3806 | 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%. |
3807 | 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%. |
3808 | 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%. |
3809 | 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%. |
3810 | PHENOL | E | Only for use in topical medicines for dermal application. The concentration of phenol in the medicine must be no more than 1%. |
3811 | 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%. |
3812 | PHENOXYETHANOL | E | Only for use in topical medicines for dermal application. The concentration of phenoxyethanol in the preparation must not exceed 15%. |
3813 | 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%. |
3814 | PHENOXYETHYLPARABEN | E | Only for use in topical medicines for dermal application. |
3815 | PHENYL DIMETHICONE | E | Only for use in topical medicines for dermal application. |
3816 | PHENYL TRIMETHICONE | E | Only for use in topical medicines for dermal application. |
3817 | 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%. |
3818 | 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%. |
3819 | 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%. |
3820 | 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%. |
3821 | PHENYLALANINE | A, E | When for oral ingestion the medicine requires the following warning statement on the medicine label: - (PKU) 'Phenylketonurics are warned that this medicine contains phenylalanine' (or words to that effect). When the medicine contains more than 500mg in the maximum recommended daily dose it requires the following warning statement on the medicine label: - (PREGNT2) 'Do not use if pregnant or likely to become pregnant'. |
3822 | 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 be no more than 4%. When used in primary sunscreen products and listed in the Register on or after 1 January 2018, the medicine must have the following statements on the medicine 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). When used in primary sunscreen products and listed in the Register before 1 January 2018, the medicine requires the following statements on the medicine label if supplied after 1 July 2019: - (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). |
3823 | 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%. |
3824 | 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%. |
3825 | 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%. |
3826 | 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%. |
3827 | 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%. |
3828 | 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%. |
3829 | 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%. |
3830 | 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%. |
3831 | 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%. |
3832 | 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%. |
3833 | PHLEUM PRATENSE | A, H | |
3834 | PHLOXINE B | E | Permitted for use only as a colour for oral and topical use. |
3835 | PHLOXINE B ALUMINIUM LAKE | E | Permitted for use only as a colour for oral and topical use. |
3836 | PHOENIX DACTYLIFERA | A, E, H | |
3837 | PHOSPHATIDYL CHOLINE | E | |
3838 | 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%. |
3839 | PHOSPHORIC ACID | E, H | The concentration in liquid medicines must be no more than 15%. |
3840 | PHOSPHORUS | H | Only for use as an active homoeopathic ingredient. |
3841 | PHOTINIA SERRULATA | A, H | |
3842 | PHRAGMITES AUSTRALIS | A, H | |
3843 | PHYLLANTHUS AMARUS | A, H | |
3844 | PHYLLANTHUS EMBLICA | A, E, H | When used as an excipient, only for use in topical medicines for dermal application. When ascorbic acid is claimed as a component the plant part is restricted to fruit. |
3845 | PHYLLOSTACHYS NIGRA | A, E, H | |
3846 | PHYSALIS ALKEKENGI | A, H | |
3847 | PHYSALIS PUBESCENS | A, H | |
3848 | PHYTANTRIOL | E | Only for use in topical medicines for dermal application. The concentration in the medicine must be no more than 0.5%. |
3849 | 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%. |
3850 | PHYTOLACCA AMERICANA | A, H | The maximum recommended daily dose of the medicine must contain no more than 1mg of the equivalent dry herb. |
3851 | PHYTOMENADIONE | A, E | |
3852 | 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%. |
3853 | 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%. |
3854 | PICEA ABIES | A, H | |
3855 | PICEA MARIANA | A, H | |
3856 | PICRASMA EXCELSA | A, E, H | |
3857 | PICRORRHIZA KURROA | A, E, H | |
3858 | 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%. |
3859 | 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%. |
3860 | 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%. |
3861 | PIGMENT RED 4 | E | Permitted for use only as a colour for topical use. |
3862 | PIGMENT RED 53 | E | Permitted for use only as a colour for topical use. |
3863 | PIGMENT RED 57 | E | Permitted for use only as a colour for topical use. |
3864 | PIGMENT RED 57 ALUMINIUM LAKE | E | Permitted for use only as a colour for topical use. |
3865 | 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. |
3866 | PIGMENT RED 63 | E | Permitted for use only as a colour for topical use. |
3867 | PIGMENT WHITE 26 | E | Permitted for use only as a colour for topical use. |
3868 | PIGMENT YELLOW 12 | E | Permitted for use only as a colour for topical use. |
3869 | 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%. |
3870 | 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%. |
3871 | 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%. |
3872 | PIMENTA FRUIT OIL | A, E, H | |
3873 | PIMENTA LEAF OIL | A, E, H | |
3874 | PIMENTA OFFICINALIS | A, E, H | |
3875 | 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'. |
3876 | 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 be no more than 50 millilitres; and b) a restricted flow insert is 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). |
3877 | PIMPINELLA SAXIFRAGA | A, E, H | |
3878 | PINE NEEDLE OIL SCOTCH | A, E, H | |
3879 | 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%. |
3880 | PINE OIL AROMATIC | A, E, H | |
3881 | PINE OIL PUMILIO | A, E, H | |
3882 | PINEAPPLE | E | |
3883 | 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%. |
3884 | PINELLIA TERNATA | A, H | |
3885 | PINUS CONTORTA | A, E, H | |
3886 | 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%. |
3887 | 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%. |
3888 | PINUS MONTICOLA | A, E, H | |
3889 | PINUS MUGO | A, E, H | |
3890 | 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%. |
3891 | 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%. |
3892 | PINUS PONDEROSA | A, E, H | |
3893 | PINUS RADIATA | A, E, H | |
3894 | PINUS STROBUS | A, E, H | |
3895 | PINUS SYLVESTRIS | A, E, H | |
3896 | PINUS TABULIFORMIS | A, E, H | |
3897 | 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%. |
3898 | 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%. |
3899 | PIPER CHABA | A, E, H | |
3900 | PIPER CUBEBA | A, E, H | |
3901 | PIPER KADSURA | A, E, H | |
3902 | PIPER LONGUM | A, E, H | |
3903 | 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. |
3904 | PIPER NIGRUM | A, E, H | |
3905 | PIPER SARMENTOSUM | A, E, H | |
3906 | PIPERIDINE | 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%. |
3907 | 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%. |
3908 | 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%. |
3909 | 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%. |
3910 | 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%. |
3911 | PIPERONYL BUTOXIDE | E | Only for use in topical medicines for dermal application. The medicine requires the following warning statement on the medicine label: - (PIPBUT) 'Contains piperonyl butoxide' (or words to that effect). |
3912 | 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. |
3913 | PISCIDIA PISCIPULA | A, E, H | |
3914 | PISTACIA LENTISCUS | A, E, H | |
3915 | PISUM SATIVUM | A, E, H | |
3916 | PLACENTA | H | Only for use as an active homoeopathic ingredient. |
3917 | PLANTAGO AFRA | A, E, H | When a dose for children is stated and the plant part is flower, seed or pollen, the medicine requires the following warning statement on the medicine label: - (PSYLL) 'On medical advice' (or words to that effect). |
3918 | PLANTAGO ARENARIA | A, H | When a dose for children is stated and the plant part is flower, seed or pollen, the medicine requires the following warning statement on the medicine label: - (PSYLL) 'On medical advice' (or words to that effect). |
3919 | PLANTAGO ASIATICA | A, H | When a dose for children is stated and the plant part is flower, seed or pollen, the medicine requires the following warning statement on the medicine label: - (PSYLL) 'On medical advice' (or words to that effect). |
3920 | 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 medicine requires the following warning statement on the medicine label: - (PSYLL) 'On medical advice' (or words to that effect). |
3921 | PLANTAGO MAJOR | A, E, H | When a dose for children is stated and the plant part is flower, seed or pollen, the medicine requires the following warning statement on the medicine label: - (PSYLL) 'On medical advice' (or words to that effect). |
3922 | PLANTAGO OVATA | A, H | When a dose for children is stated and the plant part is flower, seed or pollen, the medicine requires the following warning statement on the medicine label: - (PSYLL) 'On medical advice' (or words to that effect). |
3923 | PLANTAGO SEED DRY | A, H | When a dose for children is stated, the medicine requires the following warning statement on the medicine label: - (PSYLL) 'On medical advice' (or words to that effect). |
3924 | PLATANUS OCCIDENTALIS | A, E, H | |
3925 | PLATANUS RACEMOSA | A, H | |
3926 | PLATANUS X ACERIFOLIA | A, H | |
3927 | PLATYCODON GRANDIFLORUS | A, E, H | |
3928 | PLECTRANTHUS BARBATUS | A, E, H | |
3929 | 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%. |
3930 | PLUM | E | |
3931 | PLUMBAGO EUROPAEA | A, H | |
3932 | PLUMERIA ALBA | A, E, H | |
3933 | PLUMERIA RUBRA | A, E, H | |
3934 | POA NEMORALIS | A, H | |
3935 | POA PRATENSIS | A, H | |
3936 | 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%. |
3937 | POGOSTEMON CABLIN | A, E, H | |
3938 | POLACRILIN | E | |
3939 | POLACRILIN POTASSIUM | E | |
3940 | 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). |
3941 | POLIGLUSAM | A, E | When for internal use, the following warning statements are 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); and - (SFOOD) 'Derived from seafood'. When for internal use and the dosage form is a powdered preparation, the medicine requires the following warning statements 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. In addition, when the ingredient is included in a medicine that is listed in the Register: - on or after 1 July 2018, the medicine must comply with all requirements under (a) & (b); - before 1 July 2018 and supplied on or after 1 January 2020, the medicine must comply with all requirements under (a) & (b); or - before 1 July 2018 and supplied before 1 January 2020, the medicine may comply with requirements under (a) & (b). a) The average molecular mass of poliglusam must be greater than 2 kilodaltons. b) When for internal use, the medicine must not contain more than 1750 milligrams of poliglusam per maximum recommended daily dose. |
3942 | POLIGLUSAM DERIVED FROM ASPERGILLUS NIGER | A, E | When for oral use, the medicine must provide no more than 2000 milligrams of Poliglusam derived from Aspergillus niger per maximum recommended daily dose and requires the following warning statement 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). If the medicine is a powdered dosage form, the medicine also requires the following warning statement on the medicine label: - '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. |
3943 | 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. |
3944 | 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). |
3945 | POLOXAMER | E | Only for use in topical medicines for dermal application. |
3946 | 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%. |
3947 | POLOXAMINE 1301 | 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%. |
3948 | 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%. |
3949 | 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%. |
3950 | 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%. |
3951 | 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%. |
3952 | POLYACRYLIC ACID | E | |
3953 | POLYAMINO SUGAR CONDENSATE | E | Only for use in topical medicines for dermal application. |
3954 | 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%. |
3955 | POLYBUTENE | E | Only for use in topical medicines for dermal application. |
3956 | 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%. |
3957 | 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%. |
3958 | 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%. |
3959 | POLYDEXTROSE | E | |
3960 | 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%. |
3961 | 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% |
3962 | 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%. |
3963 | 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%. |
3964 | 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%. |
3965 | 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%. |
3966 | POLYETHYLENE | E | |
3967 | POLYGALA CHINENSIS | A, H | |
3968 | 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. |
3969 | POLYGALA SIBIRICA | A, E, H | Only for use when the plant part is root or root bark. |
3970 | POLYGALA TENUIFOLIA | A | Only for use when the plant part is root or root bark. |
3971 | 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%. |
3972 | 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%. |
3973 | 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%. |
3974 | POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE | E | Only for use in topical medicines for dermal application. The concentration in the medicine must be no more than 5%. |
3975 | 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%. |
3976 | 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%. |
3977 | POLYGLYCERYL-2-PEG-4 STEARATE | E | Only for use in topical medicines for dermal application. |
3978 | 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%. |
3979 | POLYGLYCERYL-3 DIISOSTEARATE | E | Only for use in topical medicines for dermal application. |
3980 | 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%. |
3981 | 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%. |
3982 | 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%. |
3983 | POLYGLYCERYL-3 POLYRICINOLEATE | E | |
3984 | 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%. |
3985 | 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%. |
3986 | 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%. |
3987 | POLYGLYCERYL-4 OLEATE | E | Only for use in topical medicines for dermal application. |
3988 | 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%. |
3989 | POLYGLYCERYL-6 RICINOLEATE | E | Only for use in topical medicines for dermal application. |
3990 | POLYGONATUM MULTIFLORUM | A, H | |
3991 | POLYGONATUM OFFICINALE | A, H | |
3992 | POLYGONATUM SIBIRICUM | A, E, H | |
3993 | 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%. |
3994 | POLYGONUM BISTORTA | A, H | |
3995 | POLYGONUM ODORATUM | A, H | |
3996 | POLYHYDROXYSTEARIC ACID | E | Only for use in topical medicines for dermal application. |
3997 | 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. |
3998 | POLYISOPRENE | E | Only for use in topical medicines for dermal application. |
3999 | 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%. |
4000 | POLYMETHACRYLIC ACID | E | |
4001 | POLYMETHYL METHACRYLATE | E | Only for use in topical medicines for dermal application. |
4002 | 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%. |
4003 | POLYPORUS UMBELLATUS | A, H | |
4004 | POLYPROPYLENE | E | Only for use in topical medicines for dermal application. |
4005 | 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%. |
4006 | POLYQUATERNIUM-10 | E | Only for use in topical medicines for dermal application. |
4007 | POLYQUATERNIUM-11 | E | Only for use in topical medicines for dermal application. |
4008 | 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%. |
4009 | POLYQUATERNIUM-24 | E | Only for use in topical medicines for dermal application. |
4010 | POLYQUATERNIUM-28 | E | Only for use in topical medicines for dermal application. |
4011 | 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%. |
4012 | 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%. |
4013 | 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%. |
4014 | 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%. |
4015 | POLYQUATERNIUM-7 | E | Only for use in topical medicines for dermal application. |
4016 | 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% |
4017 | 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%. |
4018 | 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 be no more than 10%. When used in primary sunscreen products and listed in the Register on or after 1 January 2018, the medicine must have the following statements on the medicine 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). When used in primary sunscreen products and listed in the Register before 1 January 2018, the medicine requires the following statements on the medicine label if supplied after 1 July 2019: - (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). |
4019 | 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%. |
4020 | POLYSORBATE 20 | E | |
4021 | POLYSORBATE 40 | E | |
4022 | POLYSORBATE 60 | E | |
4023 | POLYSORBATE 65 | E | |
4024 | POLYSORBATE 80 | E | |
4025 | POLYSORBATE 85 | E | Only for use in topical medicines for dermal application. |
4026 | 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%. |
4027 | 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. |
4028 | 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%. |
4029 | POLYVINYL ACETATE | E | Only permitted for use in medicines that are for oral routes of administration. |
4030 | POLYVINYL ACETATE PHTHALATE | E | |
4031 | POLYVINYL ALCOHOL | E | |
4032 | POLYVINYL CHLORIDE | E | Only for use in topical medicines for dermal application. |
4033 | POMEGRANATE | E | |
4034 | PONCEAU SX | E | Permitted for use only as a colour for topical use. |
4035 | 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. |
4036 | 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%. |
4037 | POPPY SEED | E, H | |
4038 | POPPY SEED OIL | E, H | |
4039 | POPULUS ALBA | A, H | |
4040 | POPULUS BALSAMIIFERA | A, E, H | |
4041 | POPULUS CANDICANS | A, H | |
4042 | POPULUS DELTOIDES | A, H | |
4043 | POPULUS NIGRA | A, H | |
4044 | POPULUS TREMULA | A, H | |
4045 | POPULUS TREMULOIDES | A, H | |
4046 | PORCINE | H | Only for use as an active homoeopathic ingredient. |
4047 | 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%. |
4048 | PORTULACA OLERACEA | A, E, H | |
4049 | POTABLE WATER | E | |
4050 | POTASSIUM ACETATE | E | |
4051 | POTASSIUM ARSENITE | H | Only for use as an active homoeopathic ingredient. |
4052 | POTASSIUM ASCORBATE | A, E, H | When for oral or sublingual use, potassium is a mandatory component of potassium ascorbate. |
4053 | POTASSIUM ASCORBATE DIHYDRATE | A, E, H | When for oral or sublingual use, potassium is a mandatory component of potassium ascorbate dihydrate. |
4054 | POTASSIUM ASCORBYL TOCOPHERYL PHOSPHATE | E | Only for use in topical medicines for dermal application. |
4055 | 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. |
4056 | 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. |
4057 | 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. |
4058 | POTASSIUM BICARBONATE | E | |
4059 | POTASSIUM BROMIDE | H | Only for use as an active homoeopathic ingredient. |
4060 | 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. |
4061 | POTASSIUM CETYL PHOSPHATE | E | Only for use in topical medicines for dermal application. |
4062 | 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: - (POTAS) 'Contains potassium. 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) other than when used for oral rehydration therapy, the concentration must be no more than 550 mg per dosage unit. Medicines 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 medicine requires the warning statements: - (UOAD) 'Use only as directed' - (DIAR3) 'If diarrhoea persists, seek medical advice.' When for dental use, the concentration in the medicine must be no more than 3.75%. |
4063 | 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. |
4064 | 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%. |
4065 | 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%. |
4066 | POTASSIUM DICHROMATE | H | Only for use as an active homoeopathic ingredient. |
4067 | 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. |
4068 | 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. |
4069 | 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. |
4070 | POTASSIUM HYDROXYCITRATE | A, H | |
4071 | 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. |
4072 | 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 contains less than 300 micrograms of iodine. When for external use, the concentration of iodine in the medicine (excluding salts derivatives or iodophors) must not exceed 2.5%. |
4073 | 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%. |
4074 | 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%. |
4075 | POTASSIUM NITRATE | A, H | Only for dental use. The concentration in the medicine must be no more than 5%. |
4076 | 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. |
4077 | 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%. |
4078 | POTASSIUM SORBATE | E | The medicine requires the following warning statement on the medicine label: - (SORB8) 'Contains sorbates' (or word to this effect) if medicine contains two or more sorbate sources OR 'Contains [insert the approved name of sorbate source used]' (or words to this effect) if medicine contains one sorbate source. |
4079 | 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%. |
4080 | POTASSIUM STEARATE | E | Only for use in topical medicines for dermal application. |
4081 | 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. |
4082 | POTATO STARCH | E | |
4083 | POTENTILLA ANSERINA | A, H | |
4084 | POTENTILLA CHINENSIS | A, H | |
4085 | POTENTILLA DISCOLOR | A, H | |
4086 | POTENTILLA ERECTA | A, E, H | |
4087 | POTENTILLA REPTANS | A, H | |
4088 | POTERIUM OFFICINALE | A, E, H | |
4089 | POTERIUM SANGUISORBA | A, H | |
4090 | POVIDONE | E | |
4091 | POWDERED CELLULOSE | E | |
4092 | 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%. |
4093 | 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%. |
4094 | 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%. |
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