3643

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%.

3644

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%.

3645

PADIMATE O

A

Only for use as an active ingredient in sunscreens for dermal application and not to be included in medicines intended for use in the eye.

The concentration in the medicine must not be more than 8%.

When used in primary sunscreen products, the following warning statements are required on the label:

- (AVOID) 'Avoid prolonged exposure in the sun' (or words to this effect); and

- (SUNPRO) 'Wear protective clothing - hats and eyewear when exposed to the sun' (or words to this effect).

3646

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%.

3647

PAEONIA LACTIFLORA

A, E, H

3648

PAEONIA OBOVATA

A, H

3649

PAEONIA SUFFRUTICOSA

A, E, H

3650

PAEONIA VEITCHII

A, H

3651

PALIURUS SPINA-CHRISTI

A, H

3652

PALLADIUM

H

Only for use as an active homoeopathic ingredient.

3653

PALM FRUIT OIL

A, E, H

3654

PALM GLYCERIDES

E

3655

PALM KERNEL OIL

A, E, H

3656

PALM TOCOTRIENOLS COMPLEX

A, H

3657

PALMARIA PALMATA

A, H

3658

PALMAROSA OIL

A, E, H

3659

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).

3660

PALMITIC ACID

E

3661

PALMITOLEIC ACID-RICH FATTY ACID ETHYL ESTERS

A

3662

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%.

3663

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%

3664

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%.

3665

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%.

3666

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%.

3667

PANAX GINSENG

A, E, H

3668

PANAX JAPONICUS

A, H

3669

PANAX NOTOGINSENG

A, H

3670

PANAX PSEUDOGINSENG

A, H

3671

PANAX QUINQUEFOLIUS

A, H

3672

PANICUM MILIACEUM

A, H

3673

PANTETHINE

E

Only for use in topical medicines for dermal application.

3674

PANTHENOL

A, E

3675

PANTHENYL ETHYL ETHER

E

Only for use in topical medicines for dermal application.

3676

PANTOLACTONE

E

3677

PANTOTHENIC ACID

A, E

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

3678

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%.

3679

PAPAIN

A, E

3680

PAPER

E

Only for use in topical medicines for dermal application.

3681

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%.

3682

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%.

3683

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%.

3684

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%.

3685

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%.

3686

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%.

3687

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%.

3688

PARA-ETHYL CRESOXYACETATE

E

Para-ethyl cresoxyacetate must only be included in medicines when in combination with other permitted ingredients as a fragrance proprietary excipient formulation.

The total concentration of the fragrance proprietary excipient formulation containing para-ethyl cresoxyacetate must not be more than 1% of the total medicine.

3689

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%.

3690

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%.

3691

PARA-HYDROXYBENZOIC ACID

E

3692

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%.

3693

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%.

3694

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%.

3695

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%.

3696

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%.

3697

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%.

3698

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%.

3699

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%.

3700

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%.

3701

PARAMERIA LAEVIGATA

A, H

3702

PARIETARIA JUDAICA

A, H

3703

PARIS POLYPHYLLA

A, H

3704

PARIS QUADRIFOLIA

A, H

3705

PARSLEY

E, H

3706

PARSLEY HERB DRY

A, E, H

3707

PARSLEY HERB OIL

A, E, H

3708

PARSLEY HERB POWDER

A, E, H

3709

PARSLEY SEED OIL

A, E, H

3710

PARTHENOCISSUS TRICUSPIDATA

A, H

3711

PARTIALLY DEHYDRATED LIQUID SORBITOL

E

Sorbitol is a mandatory component of partially dehydrated liquid sorbitol.

Permitted for use only as part of the capsule in medicines where the dosage form is a soft capsule.

3712

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%.

3713

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%.

3714

PASPALUM NOTATUM

A, H

3715

PASSIFLORA CAERULEA

A, H

3716

PASSIFLORA EDULIS

E

3717

PASSIFLORA HERB DRY

A, H

3718

PASSIFLORA INCARNATA

A, E, H

3719

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%.

3720

PATENT BLUE V

E

Permitted for use only as a colour in medicines limited to topical and oral routes of administration.

3721

PATENT BLUE V ALUMINIUM LAKE

E

Permitted for use only as a colour in medicines limited to topical and oral routes of administration.

3722

PATRINIA SCABIOSIFOLIA

A, H

3723

PATRINIA VILLOSA

A, H

3724

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 released for supply after 2 March 2021.

A medicine that contains the ingredient and that:

- was listed in the Register before 2 September 2019; and

- is released for supply 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).

3725

PAULLINIA PINNATA

A, H

3726

PAWPAW

E

3727

PEA

E

3728

PEA STARCH

E

3729

PEACH

E

3730

PEANUT

E

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

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

3731

PEAR

E

3732

PECAN

E

3733

PECTIN

A, E

3734

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%.

3735

PEG-10 SOYA STEROL

E

Only for use in topical medicines for dermal application.

3736

PEG-100 STEARATE

E

Only for use in topical medicines for dermal application.

3737

PEG-12 DILAURATE

E

3738

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%.

3739

PEG-120 METHYL GLUCOSE DIOLEATE

E

Only for use in topical medicines for dermal application.

3740

PEG-120 STEARATE

E

Only for use in topical medicines for dermal application.

3741

PEG-15 COCAMINE

E

Only for use in topical medicines for dermal application.

3742

PEG-150 DISTEARATE

E

Only for use in topical medicines for dermal application.

3743

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%.

3744

PEG-20 METHYL GLUCOSE DISTEARATE

E

Only for use in topical medicines for dermal application.

3745

PEG-20 METHYL GLUCOSE SESQUISTEARATE

E

Only for use in topical medicines for dermal application.

3746

PEG-20 SORBITAN ISOSTEARATE

E

Only for use in topical medicines for dermal application.

3747

PEG-20 STEARATE

E

Only for use in topical medicines for dermal application.

3748

PEG-25 PABA

A

Only for use as an active ingredient in sunscreens for dermal application and not to be included in medicines intended for use in the eye.

The concentration in the medicine must not be more than 10%.

When used in primary sunscreen products, the following warning statements are required on the label:

- (AVOID) 'Avoid prolonged exposure in the sun' (or words to this effect); and

- (SUNPRO) 'Wear protective clothing - hats and eyewear when exposed to the sun' (or words to this effect).

3749

PEG-30 DIPOLYHYDROXYSTEARATE

E

Only for use in topical medicines for dermal application.

3750

PEG-30 STEARATE

E

Only for use in topical medicines for dermal application.

3751

PEG-35 CASTOR OIL

E

3752

PEG-4 DILAURATE

E

Only for use in topical medicines for dermal application.

3753

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%.

3754

PEG-4 STEARATE

E

Only for use in topical medicines for dermal application.

3755

PEG-40 CASTOR OIL

E

3756

PEG-40 HYDROGENATED CASTOR OIL

E

3757

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%.

3758

PEG-40 STEARATE

E

Only for use in topical medicines for dermal application.

3759

PEG-45/DODECYL GLYCOL COPOLYMER

E

Only for use in topical medicines for dermal application.

3760

PEG-5 GLYCERYL STEARATE

E

Only for use in topical medicines for dermal application.

3761

PEG-50 STEARATE

E

Only for use in topical medicines for dermal application.

3762

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%.

3763

PEG-6 LAURAMIDE

E

Only for use in topical medicines for dermal application.

3764

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%.

3765

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%.

3766

PEG-60 HYDROGENATED CASTOR OIL

E

Only for use in topical medicines for dermal application.

3767

PEG-7 COCAMIDE

E

Only for use in topical medicines for dermal application.

3768

PEG-7 GLYCERYL COCOATE

E

Only for use in topical medicines for dermal application.

3769

PEG-7 HYDROGENATED CASTOR OIL

E

Only for use in topical medicines for dermal application.

3770

PEG-75 LANOLIN

E

Only for use in topical medicines for dermal application.

3771

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%.

3772

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%.

3773

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%.

3774

PEG-8 DISTEARATE

E

Only for use in topical medicines for dermal application.

3775

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.

3776

PEG-8 PROPYLENE GLYCOL COCOATE

E

3777

PEG-8 STEARATE

E

Only for use in topical medicines for dermal application.

3778

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%.

3779

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%.

3780

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%.

3781

PELARGONIUM GRAVEOLENS

A, E, H

3782

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%.

3783

PELTIGERA CANINA

A, H

3784

PENICILLIUM EXPANSUM

A, H

3785

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.

3786

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%

3787

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%.

3788

PENTAERYTHRITYL TETRALAURATE

E

Only for use in topical medicines for dermal application.

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

3789

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%.

3790

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%.

3791

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%.

3792

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%.

3793

PEPPER BLACK

E, H

3794

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%.

3795

PEPPER WHITE

E, H

3796

PEPPERMINT AMERICAN EXT.

E

Menthol is a mandatory component of peppermint american ext.

When the medicine is for topical use for dermal application:

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

b) the medicine must not deliver more than 25% total menthol when administered according to the directions for use;

c) the following warning statement is required on the medicine label:

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

d) if the medicine delivers more than 1% total menthol when administered according to the directions for use, the following warning statements are required on the medicine label:

- (SKTEST) If you have sensitive skin, test this product on a small area of skin before applying it to a large area;

- (IRRIT) If irritation develops, discontinue use.

e) if the medicine delivers more than 5% total menthol when administered according to the directions for use, the following warning statement is required on the medicine label:

– (MENTH) Contains a high concentration of menthol, which can cause severe skin irritation.

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

3797

PEPPERMINT LEAF DRY

A, E, H

Menthol is a mandatory component of peppermint leaf dry.

When the medicine is for topical use for dermal application:

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

(ii) the medicine must not deliver more than 25% total menthol when administered according to the directions for use;

(iii) the following warning statement is required on the medicine label:

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

(iv) if the medicine delivers more than 1% total menthol when administered according to the directions for use, the following warning statements are required on the medicine label:

- (SKTEST) If you have sensitive skin, test this product on a small area of skin before applying it to a large area;

- (IRRIT) If irritation develops, discontinue use.

(v) if the medicine delivers more than 5% total menthol when administered according to the directions for use, the following warning statement is required on the medicine label:

– (MENTH) Contains a high concentration of menthol, which can cause severe skin irritation.

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

3798

PEPPERMINT LEAF POWDER

A, E, H

Menthol is a mandatory component of peppermint leaf powder.

When the medicine is for topical use for dermal application:

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

(ii) the medicine must not deliver more than 25% total menthol when administered according to the directions for use;

(iii) the following warning statement is required on the medicine label:

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

(iv) if the medicine delivers more than 1% total menthol when administered according to the directions for use, the following warning statements are required on the medicine label:

- (SKTEST) If you have sensitive skin, test this product on a small area of skin before applying it to a large area;

- (IRRIT) If irritation develops, discontinue use.

(v) if the medicine delivers more than 5% total menthol when administered according to the directions for use, the following warning statement is required on the medicine label:

– (MENTH) Contains a high concentration of menthol, which can cause severe skin irritation.

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

3799

PEPPERMINT OIL

A, E, H

Menthol is a mandatory component of peppermint oil.

When the medicine is for topical use for dermal application:

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

(ii) the medicine must not deliver more than 25% total menthol when administered according to the directions for use;

(iii) the following warning statement is required on the medicine label:

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

(iv) if the medicine delivers more than 1% total menthol when administered according to the directions for use, the following warning statements are required on the medicine label:

- (SKTEST) If you have sensitive skin, test this product on a small area of skin before applying it to a large area;

- (IRRIT) If irritation develops, discontinue use.

(v) if the medicine delivers more than 5% total menthol when administered according to the directions for use, the following warning statement is required on the medicine label:

– (MENTH) Contains a high concentration of menthol, which can cause severe skin irritation.

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

3800

PEPPERMINT OIL TERPENELESS

E

Permitted for use only in combination with other permitted ingredients as a flavour proprietary excipient formulation or fragrance proprietary excipient formulation.

The total flavour proprietary excipient formulation in a medicine must be no more than 5%.

The total fragrance proprietary excipient formulation in a medicine must be no more 1%.

Menthol is a mandatory component of peppermint oil terpeneless.

When the medicine is for topical use for dermal application:

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

ii) the medicine must not deliver more than 25% total menthol when administered according to the directions for use;

iii) the following warning statement is required on the medicine label:

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

iv) if the medicine delivers more than 1% total menthol when administered according to the directions for use, the following warning statements are required on the medicine label:

- (SKTEST) If you have sensitive skin, test this product on a small area of skin before applying it to a large area;

- (IRRIT) If irritation develops, discontinue use.

v) if the medicine delivers more than 5% total menthol when administered according to the directions for use, the following warning statement is required on the medicine label:

– (MENTH) Contains a high concentration of menthol, which can cause severe skin irritation.

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

3801

PEPPERMINT OIL TERPENES AND TERPENOIDS

E

Permitted for use only in combination with other permitted ingredients as a flavour proprietary excipient formulation.

The total flavour proprietary excipient formulation in a medicine must be no more than 5%.

Menthol is a mandatory component of peppermint oil terpenes and terpenoids.

When the medicine is for topical use for dermal application:

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

ii) the medicine must not deliver more than 25% total menthol when administered according to the directions for use;

iii) the following warning statement is required on the medicine label:

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

iv) if the medicine delivers more than 1% total menthol when administered according to the directions for use, the following warning statements are required on the medicine label:

- (SKTEST) If you have sensitive skin, test this product on a small area of skin before applying it to a large area;

- (IRRIT) If irritation develops, discontinue use.

v) if the medicine delivers more than 5% total menthol when administered according to the directions for use, the following warning statement is required on the medicine label:

– (MENTH) Contains a high concentration of menthol, which can cause severe skin irritation.

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

3802

PERFLUOROPOLYMETHYLISOPROPYL ETHER

E

Only for use in topical medicines for dermal application.

3803

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%.

3804

PERILLA FRUTESCENS

A, E, H

3805

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%.

3806

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%.

3807

PERMETHRIN

E

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

3808

PERSEA AMERICANA

A, E, H

3809

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%.

3810

PERSICARIA CHINENSIS

A, H

3811

PERSICARIA TINCTORIA

A, H

3812

PERSIMMON

E

3813

PERU BALSAM

A, E, H

3814

PERU BALSAM OIL

A, E, H

3815

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%

3816

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%.

3817

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%.

3818

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.

3819

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%.

3820

PETROSELINUM CRISPUM

A, E, H

3821

PEUCEDANUM PRAERUPTORUM

A, E, H

3822

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).

3823

PHALARIS ARUNDINACEA

A, H

3824

PHALARIS CANARIENSIS

A, H

3825

PHASEOLUS COCCINEUS

A, H

3826

PHASEOLUS VULGARIS

A, H

3827

PHELLINUS ROBINIAE

A, E, H

3828

PHELLODENDRON AMURENSE

A, E, H

3829

PHELLODENDRON CHINENSE

A, H

3830

PHENACETIN

E

Only for use in topical medicines for dermal application.

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

3831

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%.

3832

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%.

3833

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%.

3834

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%.

3835

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%

3836

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%.

3837

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%.

3838

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%.

3839

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%.

3840

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%.

3841

PHENOL

E

Only for use in topical medicines for dermal application.

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

3842

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%.

3843

PHENOXYETHANOL

E

Only for use in topical medicines for dermal application.

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

3844

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%.

3845

PHENOXYETHYLPARABEN

E

Only for use in topical medicines for dermal application.

3846

PHENYL DIMETHICONE

E

Only for use in topical medicines for dermal application.

3847

PHENYL TRIMETHICONE

E

Only for use in topical medicines for dermal application.

3848

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%.

3849

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%.

3850

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%.

3851

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%.

3852

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'.

3853

PHENYLBENZIMIDAZOLE SULFONIC ACID

A

Only for use as an active ingredient in sunscreens for dermal application and not to be included in medicines intended for use in the eye.

The concentration in the medicine must not be more than 4%.

When used in primary sunscreen products, the following warning statements are required on the label:

- (AVOID) 'Avoid prolonged exposure in the sun' (or words to this effect); and

- (SUNPRO) 'Wear protective clothing - hats and eyewear when exposed to the sun' (or words to this effect).

3854

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%.

3855

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%.

3856

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%.

3857

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%.

3858

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%.

3859

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%.

3860

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%.

3861

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%.

3862

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%.

3863

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%.

3864

PHLEUM PRATENSE

A, H

3865

PHLOXINE B

E

Permitted for use only as a colour in medicines limited to topical and oral routes of administration.

3866

PHLOXINE B ALUMINIUM LAKE

E

Permitted for use only as a colour in medicines limited to topical and oral routes of administration.

3867

PHOENIX DACTYLIFERA

A, E, H

3868

PHOSPHATIDYL CHOLINE

E

3869

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%.

3870

PHOSPHORIC ACID

E, H

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

3871

PHOSPHORUS

H

Only for use as an active homoeopathic ingredient. 

3872

PHOTINIA SERRULATA

A, H

3873

PHRAGMITES AUSTRALIS

A, H

3874

PHYLLANTHUS AMARUS

A, H

3875

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.

3876

PHYLLOSTACHYS NIGRA

A, E, H

3877

PHYSALIS ALKEKENGI

A, H

3878

PHYSALIS PUBESCENS

A, H

3879

PHYTANTRIOL

E

Only for use in topical medicines for dermal application.

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

3880

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%.

3881

PHYTOLACCA AMERICANA

A, H

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

3882

PHYTOMENADIONE

A, E

3883

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%.

3884

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%.

3885

PICEA ABIES

A, H

3886

PICEA MARIANA

A, H

3887

PICRASMA EXCELSA

A, E, H

3888

PICRORRHIZA KURROA

A, E, H

3889

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%.

3890

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%.

3891

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%.

3892

PIGMENT RED 4

E

Permitted for use only as a colour for topical use.

3893

PIGMENT RED 53

E

Permitted for use only as a colour for topical use.

3894

PIGMENT RED 57

E

Permitted for use only as a colour for topical use.

3895

PIGMENT RED 57 ALUMINIUM LAKE

E

Permitted for use only as a colour for topical use.

3896

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.

3897

PIGMENT RED 63

E

Permitted for use only as a colour for topical use.

3898

PIGMENT WHITE 26

E

Permitted for use only as a colour for topical use.

3899

PIGMENT YELLOW 12

E

Permitted for use only as a colour for topical use.

3900

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%.

3901

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%.

3902

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%.

3903

PIMENTA FRUIT OIL

A, E, H

3904

PIMENTA LEAF OIL

A, E, H

3905

PIMENTA OFFICINALIS

A, E, H

3906

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'.

3907

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).

3908

PIMPINELLA SAXIFRAGA

A, E, H

3909

PINE NEEDLE OIL SCOTCH

A, E, H

3910

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%.

3911

PINE OIL AROMATIC

A, E, H

3912

PINE OIL PUMILIO

A, E, H

3913

PINEAPPLE

E

3914

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%.

3915

PINELLIA TERNATA

A, H

3916

PINUS CONTORTA

A, E, H

3917

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%.

3918

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%.

3919

PINUS MONTICOLA

A, E, H

3920

PINUS MUGO

A, E, H

3921

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%.

3922

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%.

3923

PINUS PONDEROSA

A, E, H

3924

PINUS RADIATA

A, E, H

3925

PINUS STROBUS

A, E, H

3926

PINUS SYLVESTRIS

A, E, H

3927

PINUS TABULIFORMIS

A, E, H

3928

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%.

3929

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%.

3930

PIPER CHABA

A, E, H

3931

PIPER CUBEBA

A, E, H

3932

PIPER KADSURA

A, E, H

3933

PIPER LONGUM

A, E, H

3934

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.

3935

PIPER NIGRUM

A, E, H

3936

PIPER SARMENTOSUM

A, E, H

3937

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%.

3938

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%.

3939

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%.

3940

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%.

3941

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%.

3942

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).

3943

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.

3944

PISCIDIA PISCIPULA

A, E, H

3945

PISTACIA LENTISCUS

A, E, H

3946

PISUM SATIVUM

A, E, H

3947

PLACENTA

H

Only for use as an active homoeopathic ingredient.

3948

PLANTAGO AFRA

A, E, H

The requirement specified in paragraph (a) below applies to a medicine that contains the ingredient that:

- is listed in the Register on or after 2 March 2020; or

- is released for supply after 2 March 2021.

(a) When a dose for children is stated and the plant part is flower, seed or pollen, the following warning statement is required on the label:

- (PSYLL1) 'Should only be used for children on medical advice' (or words to that effect).

The requirement specified in paragraph (b) below applies in relation to a medicine that contains the ingredient that:

- is listed in the Register before 2 March 2020; and

- is released for supply before 2 March 2021; and

- does not have the warning statement (PSYLL1) on the label.

(b) 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).

3949

PLANTAGO ARENARIA

A, H

The requirement specified in paragraph (a) below applies to a medicine that contains the ingredient that:

- is listed in the Register on or after 2 March 2020; or

- is released for supply after 2 March 2021.

(a) When a dose for children is stated and the plant part is flower, seed or pollen, the following warning statement is required on the label:

- (PSYLL1) 'Should only be used for children on medical advice' (or words to that effect).

The requirement specified in paragraph (b) below applies in relation to a medicine that contains the ingredient that:

- is listed in the Register before 2 March 2020; and

- is released for supply before 2 March 2021; and

- does not have the warning statement (PSYLL1) on the label.

(b) When a dose for children is stated and the plant part is flower, seed or pollen, the following warning statement is required on the label:

- (PSYLL) 'On medical advice' (or words to that effect).

3950

PLANTAGO ASIATICA

A, H

The requirement specified in paragraph (a) below applies to a medicine that contains the ingredient that:

- is listed in the Register on or after 2 March 2020; or

- is released for supply after 2 March 2021.

(a) When a dose for children is stated and the plant part is flower, seed or pollen, the following warning statement is required on the label:

- (PSYLL1) 'Should only be used for children on medical advice' (or words to that effect).

The requirement specified in paragraph (b) below applies in relation to a medicine that contains the ingredient that:

- is listed in the Register before 2 March 2020; and

- is released for supply before 2 March 2021; and

- does not have the warning statement (PSYLL1) on the label.

(b) When a dose for children is stated and the plant part is flower, seed or pollen, the following warning statement is required on the medicine label:

- (PSYLL) 'On medical advice' (or words to that effect).

3951

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’

The requirement specified in paragraph (a) below applies to a medicine that contains the ingredient that:

- is listed in the Register on or after 2 March 2020; or

- is released for supply after 2 March 2021.

(a) When a dose for children is stated and the plant part is flower, seed or pollen, the following warning statement is required on the label:

- (PSYLL1) 'Should only be used for children on medical advice' (or words to that effect).

The requirement specified in paragraph (b) below applies in relation to a medicine that contains the ingredient that:

- is listed in the Register before 2 March 2020; and

- is released for supply before 2 March 2021; and

- does not have the warning statement (PSYLL1) on the label.

(b) When a dose for children is stated and the plant part is flower, seed or pollen, the following warning statement is required on the label:

- (PSYLL) 'On medical advice' (or words to that effect).

3952

PLANTAGO MAJOR

A, E, H

The requirement specified in paragraph (a) below applies to a medicine that contains the ingredient that:

- is listed in the Register on or after 2 March 2020; or

- is released for supply after 2 March 2021.

(a) When a dose for children is stated and the plant part is flower, seed or pollen, the following warning statement is required on the label:

- (PSYLL1) 'Should only be used for children on medical advice' (or words to that effect).

The requirement specified in paragraph (b) below applies in relation to a medicine that contains the ingredient that:

- is listed in the Register before 2 March 2020; and

- is released for supply before 2 March 2021; and

- does not have the warning statement (PSYLL1) on the label.

(b) When a dose for children is stated and the plant part is flower, seed or pollen, the following warning statement is required on the label:

- (PSYLL) 'On medical advice' (or words to that effect).

3953

PLANTAGO OVATA

A, H

The requirement specified in paragraph (a) below applies to a medicine that contains the ingredient that:

- is listed in the Register on or after 2 March 2020; or

- is released for supply after 2 March 2021.

(a) When a dose for children is stated and the plant part is flower, seed or pollen, the following warning statement is required on the label:

- (PSYLL1) 'Should only be used for children on medical advice' (or words to that effect).

The requirement specified in paragraph (b) below applies in relation to a medicine that contains the ingredient that:

- is listed in the Register before 2 March 2020; and

- is released for supply before 2 March 2021; and

- does not have the warning statement (PSYLL1) on the label.

(b) 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).

3954

PLANTAGO SEED DRY

A, H

The requirement specified in paragraph (a) below applies to a medicine that contains the ingredient that:

- is listed in the Register on or after 2 March 2020; or

- is released for supply after 2 March 2021.

(a) When a dose for children is stated and the plant part is flower, seed or pollen, the following warning statement is required on the label:

- (PSYLL1) 'Should only be used for children on medical advice' (or words to that effect).

The requirement specified in paragraph (b) below applies in relation to a medicine that contains the ingredient that:

- is listed in the Register before 2 March 2020; and

- is released for supply before 2 March 2021; and

- does not have the warning statement (PSYLL1) on the label.

(b) 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).

3955

PLATANUS OCCIDENTALIS

A, E, H

3956

PLATANUS RACEMOSA

A, H

3957

PLATANUS × HISPANICA

A, H

3958

PLATYCODON GRANDIFLORUS

A, E, H

3959

PLECTRANTHUS BARBATUS

A, E, H

3960

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%.

3961

PLUM

E

3962

PLUMBAGO EUROPAEA

A, H

3963

PLUMERIA ALBA

A, E, H

3964

PLUMERIA RUBRA

A, E, H

3965

POA NEMORALIS

A, H

3966

POA PRATENSIS

A, H

3967

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%.

3968

POGOSTEMON CABLIN

A, E, H

3969

POLACRILIN

E

3970

POLACRILIN POTASSIUM

E

3971

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).

3972

POLIGLUSAM

A, E

The average molecular mass of poliglusam must be greater than 2 kilodaltons.

When for internal use, the medicine must not contain more than 1750 milligrams of poliglusam per maximum recommended daily dose.

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.

3973

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.

3974

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.

3975

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).

3976

POLOXAMER

E

Only for use in topical medicines for dermal application.

3977

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%.

3978

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%.

3979

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%.

3980

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%.

3981

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%.

3982

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%.

3983

POLYACRYLIC ACID

E

3984

POLYAMINO SUGAR CONDENSATE

E

Only for use in topical medicines for dermal application.

3985

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%.

3986

POLYBUTENE

E

Only for use in topical medicines for dermal application.

3987

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%.

3988

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%.

3989

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%.

3990

POLYDEXTROSE

E

3991

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%.

3992

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%

3993

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%.

3994

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%.

3995

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%.

3996

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%.

3997

POLYETHYLENE

E

3998

POLYGALA CHINENSIS

A, H

3999

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.

4000

POLYGALA SIBIRICA

A, E, H

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

4001

POLYGALA TENUIFOLIA

A

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

4002

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%.

4003

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%.

4004

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%.

4005

POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE

E

Only for use in topical medicines for dermal application. 

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

4006

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%.

4007

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%.

4008

POLYGLYCERYL-2-PEG-4 STEARATE

E

Only for use in topical medicines for dermal application.

4009

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%.

4010

POLYGLYCERYL-3 DIISOSTEARATE

E

Only for use in topical medicines for dermal application.

4011

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%.

4012

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%.

4013

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%.

4014

POLYGLYCERYL-3 POLYRICINOLEATE

E

4015

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%.

4016

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%.

4017

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%.

4018

POLYGLYCERYL-4 OLEATE

E

Only for use in topical medicines for dermal application.

4019

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%.

4020

POLYGLYCERYL-6 RICINOLEATE

E

Only for use in topical medicines for dermal application.

4021

POLYGONATUM MULTIFLORUM

A, H

4022

POLYGONATUM OFFICINALE

A, H

4023

POLYGONATUM SIBIRICUM

A, E, H

4024

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%.

4025

POLYGONUM BISTORTA

A, H

4026

POLYGONUM ODORATUM

A, H

4027

POLYHYDROXYSTEARIC ACID

E

Only for use in topical medicines for dermal application.

4028

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.

4029

POLYISOPRENE

E

Only for use in topical medicines for dermal application.

4030

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%.

4031

POLYMETHACRYLIC ACID

E

4032

POLYMETHYL METHACRYLATE

E

Only for use in topical medicines for dermal application.

4033

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%.

4034

POLYPORUS UMBELLATUS

A, H

4035

POLYPROPYLENE

E

Only for use in topical medicines for dermal application.

4036

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%.

4037

POLYQUATERNIUM-10

E

Only for use in topical medicines for dermal application.

4038

POLYQUATERNIUM-11

E

Only for use in topical medicines for dermal application.

4039

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%.

4040

POLYQUATERNIUM-24

E

Only for use in topical medicines for dermal application.

4041

POLYQUATERNIUM-28

E

Only for use in topical medicines for dermal application.

4042

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%.

4043

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%.

4044

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%.

4045

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%.

4046

POLYQUATERNIUM-7

E

Only for use in topical medicines for dermal application.

4047

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%

4048

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%.

4049

POLYSILICONE-15

A

Only for use as an active ingredient in sunscreens for dermal application and not to be included in medicines intended for use in the eye.

The concentration in the medicine must not be more than 10%.

When used in primary sunscreen products, the following warning statements are required on the label:

- (AVOID) 'Avoid prolonged exposure in the sun' (or words to this effect); and

- (SUNPRO) 'Wear protective clothing - hats and eyewear when exposed to the sun' (or words to this effect).

4050

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%.

4051

POLYSORBATE 20

E

4052

POLYSORBATE 40

E

4053

POLYSORBATE 60

E

4054

POLYSORBATE 65

E

4055

POLYSORBATE 80

E

4056

POLYSORBATE 85

E

Only for use in topical medicines for dermal application.

4057

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%.

4058

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.

4059

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%.

4060

POLYVINYL ACETATE

E

Only permitted for use in medicines that are for oral routes of administration.

4061

POLYVINYL ACETATE PHTHALATE

E

4062

POLYVINYL ALCOHOL

E

4063

POLYVINYL CHLORIDE

E

Only for use in topical medicines for dermal application.

4064

POMEGRANATE

E

4065

PONCEAU SX

E

Permitted for use only as a colour for topical use.

4066

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.

4067

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%.

4068

PONTEDERIA CRASSIPES

A, H

4069

POPPY SEED

E, H

4070

POPPY SEED OIL

E, H

4071

POPULUS ALBA

A, H

4072

POPULUS BALSAMIIFERA

A, E, H

4073

POPULUS CANDICANS

A, H

4074

POPULUS DELTOIDES

A, H

4075

POPULUS NIGRA

A, H

4076

POPULUS TREMULA

A, H

4077

POPULUS TREMULOIDES

A, H

4078

PORCINE

H

Only for use as an active homoeopathic ingredient. 

4079

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%.

4080

PORTULACA OLERACEA

A, E, H

4081

POTABLE WATER

E

4082

POTASSIUM ACETATE

E

4083

POTASSIUM ARSENITE

H

Only for use as an active homoeopathic ingredient.

4084

POTASSIUM ASCORBATE

A, E, H

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

4085

POTASSIUM ASCORBATE DIHYDRATE

A, E, H

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

4086

POTASSIUM ASCORBYL TOCOPHERYL PHOSPHATE

E

Only for use in topical medicines for dermal application.

4087

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.

4088

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.

4089

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.

4090

POTASSIUM BICARBONATE

E

4091

POTASSIUM BROMIDE

H

Only for use as an active homoeopathic ingredient. 

4092

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.

4093

POTASSIUM CETYL PHOSPHATE

E

Only for use in topical medicines for dermal application.

4094

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%.

4095

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.

4096

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%.

4097

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%.

4098

POTASSIUM DICHROMATE

H

Only for use as an active homoeopathic ingredient.

4099

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.

4100

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.

4101

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.

4102

POTASSIUM HYDROXYCITRATE

A, H

4103

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.

4104

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%.

4105

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%.

4106

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%.

4107

POTASSIUM NITRATE

A, H

Only for dental use.

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

4108

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.

4109

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%.

4110

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.

4111

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%.

4112

POTASSIUM STEARATE

E

Only for use in topical medicines for dermal application.

4113

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.

4114

POTATO STARCH

E

4115

POTENTILLA ANSERINA

A, H

4116

POTENTILLA CHINENSIS

A, H

4117

POTENTILLA DISCOLOR

A, H

4118

POTENTILLA ERECTA

A, E, H

4119

POTENTILLA REPTANS

A, H

4120

POTERIUM OFFICINALE

A, E, H

4121

POTERIUM SANGUISORBA

A, H

4122

POVIDONE

E

4123

POWDERED CELLULOSE

E

4124

PPG-1-PEG-9 LAURYL GLYCOL ETHER

E