3598

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%.

3599

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%.

3600

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).

3601

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%.

3602

PAEONIA LACTIFLORA

A, E, H

3603

PAEONIA OBOVATA

A, H

3604

PAEONIA SUFFRUTICOSA

A, E, H

3605

PAEONIA VEITCHII

A, H

3606

PALIURUS SPINA-CHRISTI

A, H

3607

PALLADIUM

H

Only for use as an active homoeopathic ingredient.

3608

PALM FRUIT OIL

A, E, H

3609

PALM GLYCERIDES

E

3610

PALM KERNEL OIL

A, E, H

3611

PALM TOCOTRIENOLS COMPLEX

A, H

3612

PALMARIA PALMATA

A, H

3613

PALMAROSA OIL

A, E, H

3614

PALMITIC ACID

E

3615

PALMITOLEIC ACID-RICH FATTY ACID ETHYL ESTERS

A

3616

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%.

3617

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%

3618

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%.

3619

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%.

3620

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%.

3621

PANAX GINSENG

A, E, H

3622

PANAX JAPONICUS

A, H

3623

PANAX NOTOGINSENG

A, H

3624

PANAX PSEUDOGINSENG

A, H

3625

PANAX QUINQUEFOLIUS

A, H

3626

PANICUM MILIACEUM

A, H

3627

PANTETHINE

E

Only for use in topical medicines for dermal application.

3628

PANTHENOL

A, E

3629

PANTHENYL ETHYL ETHER

E

Only for use in topical medicines for dermal application.

3630

PANTOLACTONE

E

3631

PANTOTHENIC ACID

A, E

When used topically, the concentration in the medicine must be no more than 0.1%.

3632

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%.

3633

PAPAIN

A, E

3634

PAPER

E

Only for use in topical medicines for dermal application.

3635

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%.

3636

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%.

3637

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%.

3638

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%.

3639

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%.

3640

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%.

3641

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%.

3642

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%.

3643

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%.

3644

PARA-HYDROXYBENZOIC ACID

E

3645

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%.

3646

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%.

3647

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%.

3648

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%.

3649

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%.

3650

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%.

3651

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%.

3652

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%.

3653

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%.

3654

PARAMERIA LAEVIGATA

A, H

3655

PARIETARIA JUDAICA

A, H

3656

PARIS POLYPHYLLA

A, H

3657

PARIS QUADRIFOLIA

A, H

3658

PARSLEY

E, H

3659

PARSLEY HERB DRY

A, E, H

3660

PARSLEY HERB OIL

A, E, H

3661

PARSLEY HERB POWDER

A, E, H

3662

PARSLEY SEED OIL

A, E, H

3663

PARTHENOCISSUS TRICUSPIDATA

A, H

3664

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%.

3665

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%.

3666

PASPALUM NOTATUM

A, H

3667

PASSIFLORA CAERULEA

A, H

3668

PASSIFLORA EDULIS

E

3669

PASSIFLORA HERB DRY

A, H

3670

PASSIFLORA INCARNATA

A, E, H

3671

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%.

3672

PATENT BLUE V

E

Permitted for use only as a colour for oral and topical use.

3673

PATENT BLUE V ALUMINIUM LAKE

E

Permitted for use only as a colour for oral and topical use.

3674

PATRINIA SCABIOSIFOLIA

A, H

3675

PATRINIA VILLOSA

A, H

3676

PAULLINIA CUPANA

A, E, H

Caffeine is a mandatory component of Paullinia cupana when used for oral ingestion.

When the route of administration is oral or sublingual and the medicine provides a maximum recommended daily dose of more than 1 mg but no more than 10 mg of caffeine in the medicine requires the following warning statement on the medicine label:

- (CAFFR) ‘The recommended dose of this medicine provides small amounts of caffeine.’

When the route of administration is oral or sublingual and the medicine provides a maximum recommended daily dose of more than 10 mg of caffeine in the medicine requires the following warning statement on the medicine label:

- (CAFF) ‘Contains caffeine [state quantity per dosage unit or per mL or per gram of product]’.

3677

PAULLINIA PINNATA

A, H

3678

PAWPAW

E

3679

PEA

E

3680

PEA STARCH

E

3681

PEACH

E

3682

PEANUT

E

The medicine requires the following warning statement on the medicine label:

- (PEANUT) ‘Contains Peanut’ (or words to that effect).

3683

PEAR

E

3684

PECAN

E

3685

PECTIN

A, E

3686

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%.

3687

PEG-10 SOYA STEROL

E

Only for use in topical medicines for dermal application.

3688

PEG-100 STEARATE

E

Only for use in topical medicines for dermal application.

3689

PEG-12 DILAURATE

E

3690

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%.

3691

PEG-120 METHYL GLUCOSE DIOLEATE

E

Only for use in topical medicines for dermal application.

3692

PEG-120 STEARATE

E

Only for use in topical medicines for dermal application.

3693

PEG-15 COCAMINE

E

Only for use in topical medicines for dermal application.

3694

PEG-150 DISTEARATE

E

Only for use in topical medicines for dermal application.

3695

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%.

3696

PEG-20 METHYL GLUCOSE DISTEARATE

E

Only for use in topical medicines for dermal application.

3697

PEG-20 METHYL GLUCOSE SESQUISTEARATE

E

Only for use in topical medicines for dermal application.

3698

PEG-20 SORBITAN ISOSTEARATE

E

Only for use in topical medicines for dermal application.

3699

PEG-20 STEARATE

E

Only for use in topical medicines for dermal application.

3700

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).

3701

PEG-30 DIPOLYHYDROXYSTEARATE

E

Only for use in topical medicines for dermal application.

3702

PEG-30 STEARATE

E

Only for use in topical medicines for dermal application.

3703

PEG-35 CASTOR OIL

E

3704

PEG-4 DILAURATE

E

Only for use in topical medicines for dermal application.

3705

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%.

3706

PEG-4 STEARATE

E

Only for use in topical medicines for dermal application.

3707

PEG-40 CASTOR OIL

E

3708

PEG-40 HYDROGENATED CASTOR OIL

E

3709

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%.

3710

PEG-40 STEARATE

E

Only for use in topical medicines for dermal application.

3711

PEG-45/DODECYL GLYCOL COPOLYMER

E

Only for use in topical medicines for dermal application.

3712

PEG-5 GLYCERYL STEARATE

E

Only for use in topical medicines for dermal application.

3713

PEG-50 STEARATE

E

Only for use in topical medicines for dermal application.

3714

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%.

3715

PEG-6 LAURAMIDE

E

Only for use in topical medicines for dermal application.

3716

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%.

3717

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%.

3718

PEG-60 HYDROGENATED CASTOR OIL

E

Only for use in topical medicines for dermal application.

3719

PEG-7 COCAMIDE

E

Only for use in topical medicines for dermal application.

3720

PEG-7 GLYCERYL COCOATE

E

Only for use in topical medicines for dermal application.

3721

PEG-7 HYDROGENATED CASTOR OIL

E

Only for use in topical medicines for dermal application.

3722

PEG-75 LANOLIN

E

Only for use in topical medicines for dermal application.

3723

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%.

3724

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%.

3725

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%.

3726

PEG-8 DISTEARATE

E

Only for use in topical medicines for dermal application.

3727

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.

3728

PEG-8 PROPYLENE GLYCOL COCOATE

E

3729

PEG-8 STEARATE

E

Only for use in topical medicines for dermal application.

3730

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%.

3731

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%.

3732

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%.

3733

PELARGONIUM GRAVEOLENS

A, E, H

3734

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%.

3735

PELTIGERA CANINA

A, H

3736

PENICILLIUM EXPANSUM

A, H

3737

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.

3738

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%

3739

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%.

3740

PENTAERYTHRITYL TETRALAURATE

E

Only for use in topical medicines for dermal application.

The concentration in the medicine must be no more than 80%.

3741

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%.

3742

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%.

3743

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%.

3744

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%.

3745

PEPPER BLACK

E, H

3746

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%.

3747

PEPPER WHITE

E, H

3748

PEPPERMINT AMERICAN EXT.

E

Menthol is a mandatory component of peppermint american ext.

When the medicine is for topical use:

a) the medicine must not be intended for use in the eye or on damaged skin;

b) the maximum concentration of menthol must not exceed 5%; and

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; and

- (EYE) Avoid contact with eyes (or words to that effect).

When the medicine is for internal use, the maximum recommended daily dose must not contain more than 1 gram of menthol.

3749

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:

(i) the medicine must not be intended for use in the eye or on damaged skin;

(ii) the maximum concentration of menthol must not exceed 5%; and

(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; and

- (EYE) Avoid contact with eyes (or words to that effect).

c) When the medicine is for internal use, the maximum recommended daily dose must not contain more than 1 gram of menthol.

3750

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:

(i) the medicine must not be intended for use in the eye or on damaged skin;

(ii) the maximum concentration of menthol must not exceed 5%; and

(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; and

- (EYE) Avoid contact with eyes (or words to that effect).

c) When the medicine is for internal use, the maximum recommended daily dose must not contain more than 1 gram of menthol.

3751

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:

(i) the medicine must not be intended for use in the eye or on damaged skin;

(ii) the maximum concentration of menthol must not exceed 5%; and

(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; and

- (EYE) Avoid contact with eyes (or words to that effect).

c) When the medicine is for internal use, the maximum recommended daily dose must not contain more than 1 gram of menthol.

3752

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:

a) the medicine must not be intended for use in the eye or on damaged skin;

b) the maximum concentration of menthol must not exceed 5%; and

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; and

- (EYE) Avoid contact with eyes (or words to that effect).

When the medicine is for internal use, the maximum recommended daily dose must not contain more than 1 gram of menthol.

3753

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:

a) the medicine must not be intended for use in the eye or on damaged skin;

b) the maximum concentration of menthol must not exceed 5%; and

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; and

- (EYE) Avoid contact with eyes (or words to that effect).

When the medicine is for internal use, the maximum recommended daily dose must not contain more than 1 gram of menthol.

3754

PERFLUOROPOLYMETHYLISOPROPYL ETHER

E

Only for use in topical medicines for dermal application.

3755

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%.

3756

PERILLA FRUTESCENS

A, E, H

Rosmarinic acid and vicenin-2 are only permitted for use if the plant part of Perilla frutescens is leaf.

3757

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%.

3758

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%.

3759

PERMETHRIN

E

The concentration of in the medicine must be no more than 2%.

3760

PERSEA AMERICANA

A, E, H

3761

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%.

3762

PERSICARIA CHINENSIS

A, H

3763

PERSICARIA TINCTORIA

A, H

3764

PERSIMMON

E

3765

PERU BALSAM

A, E, H

3766

PERU BALSAM OIL

A, E, H

3767

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%

3768

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%.

3769

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%.

3770

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.

3771

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%.

3772

PETROSELINUM CRISPUM

A, E, H

3773

PEUCEDANUM PRAERUPTORUM

A, E, H

3774

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).

3775

PHALARIS ARUNDINACEA

A, H

3776

PHALARIS CANARIENSIS

A, H

3777

PHASEOLUS COCCINEUS

A, H

3778

PHASEOLUS VULGARIS

A, H

3779

PHELLINUS ROBINIAE

A, E, H

3780

PHELLODENDRON AMURENSE

A, E, H

3781

PHELLODENDRON CHINENSE

A, H

3782

PHENACETIN

E

Only for use in topical medicines for dermal application.

The concentration in the medicine must be no more than 0.1%.

3783

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%.

3784

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%.

3785

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%.

3786

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%.

3787

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%

3788

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%.

3789

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%.

3790

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%.

3791

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%.

3792

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%.

3793

PHENOL

E

Only for use in topical medicines for dermal application.

The concentration of phenol in the medicine must be no more than 1%.

3794

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%.

3795

PHENOXYETHANOL

E

Only for use in topical medicines for dermal application.

The concentration of phenoxyethanol in the preparation must not exceed 15%.

3796

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%.

3797

PHENOXYETHYLPARABEN

E

Only for use in topical medicines for dermal application.

3798

PHENYL DIMETHICONE

E

Only for use in topical medicines for dermal application.

3799

PHENYL TRIMETHICONE

E

Only for use in topical medicines for dermal application.

3800

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%.

3801

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%.

3802

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%.

3803

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%.

3804

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'.

3805

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).

3806

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%.

3807

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%.

3808

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%.

3809

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%.

3810

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%.

3811

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%.

3812

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%.

3813

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%.

3814

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%.

3815

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%.

3816

PHLEUM PRATENSE

A, H

3817

PHLOXINE B

E

Permitted for use only as a colour for oral and topical use.

3818

PHLOXINE B ALUMINIUM LAKE

E

Permitted for use only as a colour for oral and topical use.

3819

PHOENIX DACTYLIFERA

A, E, H

3820

PHOSPHATIDYL CHOLINE

E

3821

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%.

3822

PHOSPHORIC ACID

E, H

The concentration in liquid medicines must be no more than 15%.

3823

PHOSPHORUS

H

Only for use as an active homoeopathic ingredient. 

3824

PHOTINIA SERRULATA

A, H

3825

PHRAGMITES AUSTRALIS

A, H

3826

PHYLLANTHUS AMARUS

A, H

3827

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.

3828

PHYLLOSTACHYS NIGRA

A, E, H

3829

PHYSALIS ALKEKENGI

A, H

3830

PHYSALIS PUBESCENS

A, H

3831

PHYTANTRIOL

E

Only for use in topical medicines for dermal application.

The concentration in the medicine must be no more than 0.5%.

3832

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%.

3833

PHYTOLACCA AMERICANA

A, H

The maximum recommended daily dose of the medicine must contain no more than 1mg of the equivalent dry herb.

3834

PHYTOMENADIONE

A, E

3835

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%.

3836

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%.

3837

PICEA ABIES

A, H

3838

PICEA MARIANA

A, H

3839

PICRASMA EXCELSA

A, E, H

3840

PICRORRHIZA KURROA

A, E, H

3841

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%.

3842

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%.

3843

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%.

3844

PIGMENT RED 4

E

Permitted for use only as a colour for topical use.

3845

PIGMENT RED 53

E

Permitted for use only as a colour for topical use.

3846

PIGMENT RED 57

E

Permitted for use only as a colour for topical use.

3847

PIGMENT RED 57 ALUMINIUM LAKE

E

Permitted for use only as a colour for topical use.

3848

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.

3849

PIGMENT RED 63

E

Permitted for use only as a colour for topical use.

3850

PIGMENT WHITE 26

E

Permitted for use only as a colour for topical use.

3851

PIGMENT YELLOW 12

E

Permitted for use only as a colour for topical use.

3852

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%.

3853

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%.

3854

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%.

3855

PIMENTA FRUIT OIL

A, E, H

3856

PIMENTA LEAF OIL

A, E, H

3857

PIMENTA OFFICINALIS

A, E, H

3858

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'.

3859

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).

3860

PIMPINELLA SAXIFRAGA

A, E, H

3861

PINE NEEDLE OIL SCOTCH

A, E, H

3862

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%.

3863

PINE OIL AROMATIC

A, E, H

3864

PINE OIL PUMILIO

A, E, H

3865

PINEAPPLE

E

3866

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%.

3867

PINELLIA TERNATA

A, H

3868

PINUS CONTORTA

A, E, H

3869

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%.

3870

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%.

3871

PINUS MONTICOLA

A, E, H

3872

PINUS MUGO

A, E, H

3873

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%.

3874

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%.

3875

PINUS PONDEROSA

A, E, H

3876

PINUS RADIATA

A, E, H

3877

PINUS STROBUS

A, E, H

3878

PINUS SYLVESTRIS

A, E, H

3879

PINUS TABULIFORMIS

A, E, H

3880

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%.

3881

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%.

3882

PIPER CHABA

A, E, H

3883

PIPER CUBEBA

A, E, H

3884

PIPER KADSURA

A, E, H

3885

PIPER LONGUM

A, E, H

3886

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.

3887

PIPER NIGRUM

A, E, H

3888

PIPER SARMENTOSUM

A, E, H

3889

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%.

3890

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%.

3891

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%.

3892

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%.

3893

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%.

3894

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).

3895

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.

3896

PISCIDIA PISCIPULA

A, E, H

3897

PISTACIA LENTISCUS

A, E, H

3898

PISUM SATIVUM

A, E, H

3899

PLACENTA

H

Only for use as an active homoeopathic ingredient.

3900

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).

3901

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).

3902

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).

3903

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).

3904

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).

3905

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).

3906

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).

3907

PLATANUS OCCIDENTALIS

A, E, H

3908

PLATANUS RACEMOSA

A, H

3909

PLATANUS X ACERIFOLIA

A, H

3910

PLATYCODON GRANDIFLORUS

A, E, H

3911

PLECTRANTHUS BARBATUS

A, E, H

3912

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%.

3913

PLUM

E

3914

PLUMBAGO EUROPAEA

A, H

3915

PLUMERIA ALBA

A, E, H

3916

PLUMERIA RUBRA

A, E, H

3917

POA NEMORALIS

A, H

3918

POA PRATENSIS

A, H

3919

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%.

3920

POGOSTEMON CABLIN

A, E, H

3921

POLACRILIN

E

3922

POLACRILIN POTASSIUM

E

3923

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).

3924

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.

3925

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.

3926

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.

3927

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).

3928

POLOXAMER

E

Only for use in topical medicines for dermal application.

3929

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%.

3930

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%.

3931

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%.

3932

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%.

3933

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%.

3934

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%.

3935

POLYACRYLIC ACID

E

3936

POLYAMINO SUGAR CONDENSATE

E

Only for use in topical medicines for dermal application.

3937

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%.

3938

POLYBUTENE

E

Only for use in topical medicines for dermal application.

3939

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%.

3940

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%.

3941

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%.

3942

POLYDEXTROSE

E

3943

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%.

3944

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%

3945

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%.

3946

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%.

3947

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%.

3948

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%.

3949

POLYETHYLENE

E

3950

POLYGALA CHINENSIS

A, H

3951

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.

3952

POLYGALA SIBIRICA

A, E, H

Only for use when the plant part is root or root bark.

3953

POLYGALA TENUIFOLIA

A

Only for use when the plant part is root or root bark.

3954

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%.

3955

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%.

3956

POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE

E

Only for use in topical medicines for dermal application. 

The concentration in the medicine must be no more than 5%.

3957

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.

The concentration in the medicine must be no more than 3%.

3958

POLYGLYCERYL-2-PEG-4 STEARATE

E

Only for use in topical medicines for dermal application.

3959

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%.

3960

POLYGLYCERYL-3 DIISOSTEARATE

E

Only for use in topical medicines for dermal application.

3961

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%.

3962

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%.

3963

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%.

3964

POLYGLYCERYL-3 POLYRICINOLEATE

E

3965

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%.

3966

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%.

3967

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%.

3968

POLYGLYCERYL-4 OLEATE

E

Only for use in topical medicines for dermal application.

3969

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%.

3970

POLYGLYCERYL-6 RICINOLEATE

E

Only for use in topical medicines for dermal application.

3971

POLYGONATUM MULTIFLORUM

A, H

3972

POLYGONATUM OFFICINALE

A, H

3973

POLYGONATUM SIBIRICUM

A, E, H

3974

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%.

3975

POLYGONUM BISTORTA

A, H

3976

POLYGONUM ODORATUM

A, H

3977

POLYHYDROXYSTEARIC ACID

E

Only for use in topical medicines for dermal application.

3978

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.

3979

POLYISOPRENE

E

Only for use in topical medicines for dermal application.

3980

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%.

3981

POLYMETHACRYLIC ACID

E

3982

POLYMETHYL METHACRYLATE

E

Only for use in topical medicines for dermal application.

3983

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%.

3984

POLYPORUS UMBELLATUS

A, H

3985

POLYPROPYLENE

E

Only for use in topical medicines for dermal application.

3986

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%.

3987

POLYQUATERNIUM-10

E

Only for use in topical medicines for dermal application.

3988

POLYQUATERNIUM-11

E

Only for use in topical medicines for dermal application.

3989

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%.

3990

POLYQUATERNIUM-24

E

Only for use in topical medicines for dermal application.

3991

POLYQUATERNIUM-28

E

Only for use in topical medicines for dermal application.

3992

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%.

3993

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%.

3994

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%.

3995

POLYQUATERNIUM-7

E

Only for use in topical medicines for dermal application.

3996

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%

3997

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%.

3998

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).

3999

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%.

4000

POLYSORBATE 20

E

4001

POLYSORBATE 40

E

4002

POLYSORBATE 60

E

4003

POLYSORBATE 65

E

4004

POLYSORBATE 80

E

4005

POLYSORBATE 85

E

Only for use in topical medicines for dermal application.

4006

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%.

4007

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.

4008

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%.

4009

POLYVINYL ACETATE

E

Only for use when the dosage form is chewing gum.

4010

POLYVINYL ACETATE PHTHALATE

E

4011

POLYVINYL ALCOHOL

E

4012

POLYVINYL CHLORIDE

E

Only for use in topical medicines for dermal application.

4013

POMEGRANATE

E

4014

PONCEAU SX

E

Permitted for use only as a colour for topical use.

4015

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.

4016

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%.

4017

POPPY SEED

E, H

4018

POPPY SEED OIL

E, H

4019

POPULUS ALBA

A, H

4020

POPULUS BALSAMIIFERA

A, E, H

4021

POPULUS CANDICANS

A, H

4022

POPULUS DELTOIDES

A, H

4023

POPULUS NIGRA

A, H

4024

POPULUS TREMULA

A, H

4025

POPULUS TREMULOIDES

A, H

4026

PORCINE

H

Only for use as an active homoeopathic ingredient. 

4027

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%.

4028

PORTULACA OLERACEA

A, E, H

4029

POTABLE WATER

E

4030

POTASSIUM ACETATE

E

4031

POTASSIUM ARSENITE

H

Only for use as an active homoeopathic ingredient.

4032

POTASSIUM ASCORBATE

A, E, H

When for oral or sublingual use, potassium is a mandatory component of potassium ascorbate.

4033

POTASSIUM ASCORBATE DIHYDRATE

A, E, H

When for oral or sublingual use, potassium is a mandatory component of potassium ascorbate dihydrate.

4034

POTASSIUM ASCORBYL TOCOPHERYL PHOSPHATE

E

Only for use in topical medicines for dermal application.

4035

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.

4036

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.

4037

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.

4038

POTASSIUM BICARBONATE

E

4039

POTASSIUM BROMIDE

H

Only for use as an active homoeopathic ingredient. 

4040

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.

4041

POTASSIUM CETYL PHOSPHATE

E

Only for use in topical medicines for dermal application.

4042

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%.

4043

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.

4044

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%.

4045

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%.

4046

POTASSIUM DICHROMATE

H

Only for use as an active homoeopathic ingredient.

4047

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.

4048

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.

4049

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.

4050

POTASSIUM HYDROXYCITRATE

A, H

4051

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.

4052

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%.

4053

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%.

4054

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%.

4055

POTASSIUM NITRATE

A, H

Only for dental use.

The concentration in the medicine must be no more than 5%.

4056

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.

4057

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%.

4058

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.

4059

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%.

4060

POTASSIUM STEARATE

E

Only for use in topical medicines for dermal application.

4061

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.

4062

POTATO STARCH

E

4063

POTENTILLA ANSERINA

A, H

4064

POTENTILLA CHINENSIS

A, H

4065

POTENTILLA DISCOLOR

A, H

4066

POTENTILLA ERECTA

A, E, H

4067

POTENTILLA REPTANS

A, H

4068

POTERIUM OFFICINALE

A, E, H

4069

POTERIUM SANGUISORBA

A, H

4070

POVIDONE

E

4071

POWDERED CELLULOSE

E

4072

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%.

4073

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%.

4074

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%.

4075

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%.

4076

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%.

4077

PPG-2 LANOLIN ALCOHOL ETHER

E

Only for use in topical medicines for dermal application.

4078

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%.

4079

PPG-20 LANOLIN ALCOHOL ETHER

E

Only for use in topical medicines for dermal application.

4080

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%.

4081

PPG-20 METHYL GLUCOSE ETHER DISTEARATE

E

Only for use in topical medicines for dermal application.

4082

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%.

4083

PPG-3 MYRISTYL ETHER

E

Only for use in topical medicines for dermal application.

4084

PPG-5-CETETH-20

E

Only for use in topical medicines for dermal application.

4085

PPG-5-LAUROMACROGOL 250

E

Only for use in topical medicines for dermal application.

4086

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%.

4087

PREGELATINISED MAIZE STARCH

E

4088

PREGELATINISED POTATO STARCH

E

4089

PREGELATINISED RICE STARCH

E

4090

PREGELATINISED WHEAT STARCH

E

When the route of administration is other than topical or mucosal, gluten is a mandatory component of pregelatinised wheat starch.

When the route of administration is other than topical or mucosal, the medicine requires the following warning statement on the medicine label:

- (GLUTEN) 'Contains [insert name of ingredient]' (or words to that effect).

4091

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%.

4092

PRICKLY ASH BARK DRY

A, H