Permissible ingredients and requirements

Column 1

Column 2

Column 3

Column 4

Item

Ingredient Name

Purpose

Specific requirements

3634

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%.

3635

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%.

3636

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).

3637

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%.

3638

PAEONIA LACTIFLORA

A, E, H

3639

PAEONIA OBOVATA

A, H

3640

PAEONIA SUFFRUTICOSA

A, E, H

3641

PAEONIA VEITCHII

A, H

3642

PALIURUS SPINA-CHRISTI

A, H

3643

PALLADIUM

H

Only for use as an active homoeopathic ingredient.

3644

PALM FRUIT OIL

A, E, H

3645

PALM GLYCERIDES

E

3646

PALM KERNEL OIL

A, E, H

3647

PALM TOCOTRIENOLS COMPLEX

A, H

3648

PALMARIA PALMATA

A, H

3649

PALMAROSA OIL

A, E, H

3650

PALMIDROL

A

Only permitted for use in medicines limited to oral routes of administration.

The maximum recommended daily dose of the medicine must not provide more than 600 mg of palmidrol.

The following warning statements (or words to the same effect) are required on the medicine label:

- (ANALG) 'The medicine may interact with other prescription analgesic medicines, please consult your healthcare practitioner before use.'

- (ADULT) ‘Adults only.’

- (21DAYS) ‘Not to be used for more than 21 consecutive days.’

3651

PALMITIC ACID

E

3652

PALMITOLEIC ACID-RICH FATTY ACID ETHYL ESTERS

A

3653

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%.

3654

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%

3655

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%.

3656

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%.

3657

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%.

3658

PANAX GINSENG

A, E, H

3659

PANAX JAPONICUS

A, H

3660

PANAX NOTOGINSENG

A, H

3661

PANAX PSEUDOGINSENG

A, H

3662

PANAX QUINQUEFOLIUS

A, H

3663

PANICUM MILIACEUM

A, H

3664

PANTETHINE

E

Only for use in topical medicines for dermal application.

3665

PANTHENOL

A, E

3666

PANTHENYL ETHYL ETHER

E

Only for use in topical medicines for dermal application.

3667

PANTOLACTONE

E

3668

PANTOTHENIC ACID

A, E

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

3669

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%.

3670

PAPAIN

A, E

3671

PAPER

E

Only for use in topical medicines for dermal application.

3672

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%.

3673

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%.

3674

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%.

3675

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%.

3676

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%.

3677

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%.

3678

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%.

3679

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.

3680

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%.

3681

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%.

3682

PARA-HYDROXYBENZOIC ACID

E

3683

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%.

3684

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%.

3685

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%.

3686

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%.

3687

PARA-PROPYL ANISOLE

E

Para-propyl anisole must only be included in medicines when in combination with other permitted ingredients as a fragrance and/or flavour proprietary excipient formulation.

 The total concentration of fragrance proprietary excipient formulations containing para-propyl anisole must not be more than 1% of the total medicine.

The total concentration of flavour proprietary excipient formulations containing para-propyl anisole must not be more than 5% of the total medicine.

3688

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%.

3689

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%.

3690

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%.

3691

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%.

3692

PARAMERIA LAEVIGATA

A, H

3693

PARIETARIA JUDAICA

A, H

3694

PARIS POLYPHYLLA

A, H

3695

PARIS QUADRIFOLIA

A, H

3696

PARSLEY HERB DRY

A, E, H

3697

PARSLEY HERB OIL

A, E, H

3698

PARSLEY HERB POWDER

A, E, H

3699

PARSLEY SEED OIL

A, E, H

3700

PARTHENOCISSUS TRICUSPIDATA

A, H

3701

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.

3702

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%.

3703

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%.

3704

PASPALUM NOTATUM

A, H

3705

PASSIFLORA CAERULEA

A, H

3706

PASSIFLORA EDULIS

E

3707

PASSIFLORA HERB DRY

A, H

3708

PASSIFLORA INCARNATA

A, E, H

3709

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%.

3710

PATENT BLUE V

E

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

3711

PATENT BLUE V ALUMINIUM LAKE

E

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

3712

PATRINIA SCABIOSIFOLIA

A, H

3713

PATRINIA VILLOSA

A, H

3714

PAULLINIA CUPANA

A, E, H

Caffeine is a mandatory component of Paullinia cupana.

When the medicine is packaged for supply as a divided preparation and is for internal use or oral application, the medicine must not contain a concentration of total caffeine greater than 33%.

When for internal use or oral application, the maximum recommended daily dose of the medicine must provide no more than 400 mg of total caffeine.

When the medicine is packaged for supply as an undivided preparation and is for internal use or oral application, the medicine must not contain a concentration of total caffeine greater than 1%.

When the medicine is for internal use or oral application, a maximum recommended dose of the medicine must not provide more than 100 mg of total caffeine within a 3 hour period.

When the maximum recommended daily dose of the medicine provides greater than 10 mg of total caffeine and the medicine is for internal use or oral application, the following warning statements are required on the label:

- (ADULT) 'Adults only' (or words to that effect).

- (CAFF) 'Contains [state quantity per dosage unit or per mL or per gram of product] total caffeine [per dosage unit or per mL or per gram]. A cup of instant coffee contains approximately 80mg of caffeine.'

- (CAFFPREG) ‘Caffeine intake more than 200 mg per day is not recommended during pregnancy or breastfeeding.’

When the maximum recommended daily dose of the medicine provides greater than 80 mg of total caffeine and the medicines is for internal use or oral application, the following warning statements are required on the label:

- (CAFFLMT) 'Limit the use of caffeine-containing products (including tea and coffee) when taking this product.'

- (CAFFCYP) ‘Caffeine interacts with enzyme CYP1A2 in the liver. Consult your health professional before taking with other medicines’ (or words to that effect).

3715

PAULLINIA PINNATA

A, H

3716

PAWPAW

E

3717

PEA

E

3718

PEA STARCH

E

3719

PEACH

E

3720

PEAR

E

3721

PECAN

E

3722

PECTIN

A, E

3723

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%.

3724

PEG-10 SOYA STEROL

E

Only for use in topical medicines for dermal application.

3725

PEG-100 STEARATE

E

Only for use in topical medicines for dermal application.

3726

PEG-12 DILAURATE

E

3727

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%.

3728

PEG-120 METHYL GLUCOSE DIOLEATE

E

Only for use in topical medicines for dermal application.

3729

PEG-120 STEARATE

E

Only for use in topical medicines for dermal application.

3730

PEG-15 COCAMINE

E

Only for use in topical medicines for dermal application.

3731

PEG-150 DISTEARATE

E

Only for use in topical medicines for dermal application.

3732

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%.

3733

PEG-20 METHYL GLUCOSE DISTEARATE

E

Only for use in topical medicines for dermal application.

3734

PEG-20 METHYL GLUCOSE SESQUISTEARATE

E

Only for use in topical medicines for dermal application.

3735

PEG-20 SORBITAN ISOSTEARATE

E

Only for use in topical medicines for dermal application.

3736

PEG-20 STEARATE

E

Only for use in topical medicines for dermal application.

3737

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).

3738

PEG-30 DIPOLYHYDROXYSTEARATE

E

Only for use in topical medicines for dermal application.

3739

PEG-30 STEARATE

E

Only for use in topical medicines for dermal application.

3740

PEG-35 CASTOR OIL

E

3741

PEG-4 DILAURATE

E

Only for use in topical medicines for dermal application.

3742

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%.

3743

PEG-4 STEARATE

E

Only for use in topical medicines for dermal application.

3744

PEG-40 CASTOR OIL

E

3745

PEG-40 HYDROGENATED CASTOR OIL

E

3746

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%.

3747

PEG-40 STEARATE

E

Only for use in topical medicines for dermal application.

3748

PEG-45/DODECYL GLYCOL COPOLYMER

E

Only for use in topical medicines for dermal application.

3749

PEG-5 GLYCERYL STEARATE

E

Only for use in topical medicines for dermal application.

3750

PEG-50 STEARATE

E

Only for use in topical medicines for dermal application.

3751

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%.

3752

PEG-6 LAURAMIDE

E

Only for use in topical medicines for dermal application.

3753

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%.

3754

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%.

3755

PEG-60 HYDROGENATED CASTOR OIL

E

Only for use in topical medicines for dermal application.

3756

PEG-7 COCAMIDE

E

Only for use in topical medicines for dermal application.

3757

PEG-7 GLYCERYL COCOATE

E

Only for use in topical medicines for dermal application.

3758

PEG-7 HYDROGENATED CASTOR OIL

E

Only for use in topical medicines for dermal application.

3759

PEG-75 LANOLIN

E

Only for use in topical medicines for dermal application.

3760

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%.

3761

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%.

3762

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%.

3763

PEG-8 DISTEARATE

E

Only for use in topical medicines for dermal application.

3764

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.

3765

PEG-8 PROPYLENE GLYCOL COCOATE

E

3766

PEG-8 STEARATE

E

Only for use in topical medicines for dermal application.

3767

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%.

3768

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%.

3769

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%.

3770

PELARGONIUM GRAVEOLENS

A, E, H

3771

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%.

3772

PELTIGERA CANINA

A, H

3773

PENICILLIUM EXPANSUM

A, H

3774

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.

3775

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%

3776

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%.

3777

PENTAERYTHRITYL TETRALAURATE

E

Only for use in topical medicines for dermal application.

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

3778

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%.

3779

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%.

3780

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%.

3781

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%.

3782

PEPPER BLACK

E, H

3783

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%.

3784

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.

3785

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.

3786

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.

3787

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.

3788

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.

3789

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.

3790

PERFLUOROPOLYMETHYLISOPROPYL ETHER

E

Only for use in topical medicines for dermal application.

3791

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%.

3792

PERILLA FRUTESCENS

A, E, H

3793

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%.

3794

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%.

3795

PERMETHRIN

E

The total concentration of permethrin in the medicine must not be more than 2%.

3796

PERSEA AMERICANA

A, E, H

3797

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%.

3798

PERSICARIA CHINENSIS

A, H

3799

PERSICARIA TINCTORIA

A, H

3800

PERU BALSAM

A, E, H

3801

PERU BALSAM OIL

A, E, H

3802

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%

3803

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%.

3804

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%.

3805

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.

3806

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%.

3807

PETROSELINUM CRISPUM

A, E, H

3808

PEUCEDANUM PRAERUPTORUM

A, E, H

3809

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).

3810

PHALARIS ARUNDINACEA

A, H

3811

PHALARIS CANARIENSIS

A, H

3812

PHASEOLUS COCCINEUS

A, H

3813

PHASEOLUS VULGARIS

A, H

3814

PHELLINUS ROBINIAE

A, E, H

3815

PHELLODENDRON AMURENSE

A, E, H

3816

PHELLODENDRON CHINENSE

A, H

3817

PHENACETIN

E

Only for use in topical medicines for dermal application.

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

3818

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%.

3819

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%.

3820

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%.

3821

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%.

3822

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%

3823

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%.

3824

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%.

3825

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%.

3826

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%.

3827

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%.

3828

PHENOL

E

Only for use in topical medicines for dermal application.

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

3829

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%.

3830

PHENOXYETHANOL

E

Only for use in topical medicines for dermal application.

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

3831

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%.

3832

PHENOXYETHYLPARABEN

E

Only for use in topical medicines for dermal application.

3833

PHENYL DIMETHICONE

E

Only for use in topical medicines for dermal application.

3834

PHENYL TRIMETHICONE

E

Only for use in topical medicines for dermal application.

3835

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%.

3836

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%.

3837

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%.

3838

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%.

3839

PHENYLALANINE

A, E

When the maximum recommended daily dose of the medicine provides more than 500 mg phenylalanine, the following warning statement is required on the medicine label:

- (PREGNT2) 'Do not use if pregnant or likely to become pregnant'.

3840

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).

3841

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%.

3842

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%.

3843

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%.

3844

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%.

3845

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%.

3846

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%.

3847

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%.

3848

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%.

3849

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%.

3850

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%.

3851

PHLEUM PRATENSE

A, H

3852

PHLOXINE B

E

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

3853

PHLOXINE B ALUMINIUM LAKE

E

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

3854

PHOENIX DACTYLIFERA

A, E, H

3855

PHOSPHATIDYL CHOLINE

E

3856

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%.

3857

PHOSPHORIC ACID

E, H

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

3858

PHOSPHORUS

H

Only for use as an active homoeopathic ingredient.

The total concentration of phosphorus in the medicine must not be more than 1 mg/kg or 1 mg/L or 0.0001%.

3859

PHOTINIA SERRULATA

A, H

3860

PHRAGMITES AUSTRALIS

A, H

3861

PHYLLANTHUS AMARUS

A, H

3862

PHYLLANTHUS EMBLICA

A, E, H

When used as an excipient, only for use in topical medicines for dermal application.

3863

PHYLLOSTACHYS NIGRA

A, E, H

3864

PHYSALIS ALKEKENGI

A, H

3865

PHYSALIS PUBESCENS

A, H

3866

PHYTANTRIOL

E

Only for use in topical medicines for dermal application.

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

3867

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%.

3868

PHYTOLACCA AMERICANA

A, H

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

3869

PHYTOMENADIONE

A, E

3870

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%.

3871

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%.

3872

PICEA ABIES

A, H

3873

PICEA MARIANA

A, H

3874

PICRASMA EXCELSA

A, E, H

3875

PICRORRHIZA KURROA

A, E, H

3876

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%.

3877

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%.

3878

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%.

3879

PIGMENT RED 4

E

Permitted for use only as a colour for topical use.

3880

PIGMENT RED 53

E

Permitted for use only as a colour for topical use.

3881

PIGMENT RED 57

E

Permitted for use only as a colour for topical use.

3882

PIGMENT RED 57 ALUMINIUM LAKE

E

Permitted for use only as a colour for topical use.

3883

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.

3884

PIGMENT RED 63

E

Permitted for use only as a colour for topical use.

3885

PIGMENT WHITE 26

E

Permitted for use only as a colour for topical use.

3886

PIGMENT YELLOW 12

E

Permitted for use only as a colour for topical use.

3887

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%.

3888

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%.

3889

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%.

3890

PIMENTA FRUIT OIL

A, E, H

3891

PIMENTA LEAF OIL

A, E, H

3892

PIMENTA OFFICINALIS

A, E, H

3893

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'.

3894

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).

3895

PIMPINELLA SAXIFRAGA

A, E, H

3896

PINE NEEDLE OIL SCOTCH

A, E, H

3897

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%.

3898

PINE OIL AROMATIC

A, E, H

3899

PINE OIL PUMILIO

A, E, H

3900

PINEAPPLE

E

3901

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%.

3902

PINELLIA TERNATA

A, H

3903

PINUS CONTORTA

A, E, H

3904

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%.

3905

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%.

3906

PINUS MONTICOLA

A, E, H

3907

PINUS MUGO

A, E, H

3908

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%.

3909

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%.

3910

PINUS PONDEROSA

A, E, H

3911

PINUS RADIATA

A, E, H

3912

PINUS STROBUS

A, E, H

3913

PINUS SYLVESTRIS

A, E, H

3914

PINUS TABULIFORMIS

A, E, H

3915

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%.

3916

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%.

3917

PIPER CHABA

A, E, H

3918

PIPER CUBEBA

A, E, H

3919

PIPER KADSURA

A, E, H

3920

PIPER LONGUM

A, E, H

3921

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.

3922

PIPER NIGRUM

A, E, H

3923

PIPER SARMENTOSUM

A, E, H

3924

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%.

3925

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%.

3926

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%.

3927

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%.

3928

PIPERONYL BUTOXIDE

E

Only for use in topical medicines for dermal application.

3929

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.

3930

PISCIDIA PISCIPULA

A, E, H

3931

PISTACIA LENTISCUS

A, E, H

3932

PISUM SATIVUM

A, E, H

3933

PLACENTA

H

Only for use as an active homoeopathic ingredient.

3934

PLANTAGO AFRA

A, E, H

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

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

3935

PLANTAGO ARENARIA

A, H

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

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

3936

PLANTAGO ASIATICA

A, H

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

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

3937

PLANTAGO LANCEOLATA

A, E, H

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

- (CHILD5) 'Use in children under 3 years is not recommended’

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

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

3938

PLANTAGO MAJOR

A, E, H

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

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

3939

PLANTAGO OVATA

A, H

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

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

3940

PLANTAGO SEED DRY

A, H

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

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

3941

PLATANUS OCCIDENTALIS

A, E, H

3942

PLATANUS RACEMOSA

A, H

3943

PLATANUS × HISPANICA

A, H

3944

PLATYCODON GRANDIFLORUS

A, E, H

3945

PLECTRANTHUS BARBATUS

A, E, H

3946

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%.

3947

PLUM

E

3948

PLUMBAGO EUROPAEA

A, H

3949

PLUMERIA ALBA

A, E, H

3950

PLUMERIA RUBRA

A, E, H

3951

POA NEMORALIS

A, H

3952

POA PRATENSIS

A, H

3953

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%.

3954

POGOSTEMON CABLIN

A, E, H

3955

POLACRILIN

E

3956

POLACRILIN POTASSIUM

E

3957

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).

3958

POLIGLUSAM

A, E

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

When for internal use:

(a) the maximum recommended daily dose of the medicine must not provide more than 1750 milligrams poliglusam; and

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

- (CHITO) 'Poliglusam should be taken at least one hour after any other medication as it may reduce the effect of other medication' (or words to that effect).

When for internal use and the dosage form is a powdered preparation, the following warning statement is required on the medicine label:

- (DNTPOW) 'Do not take powder alone. Mix with food or fluid'.

When used as an excipient, only for use in topical medicines for dermal application.

3959

POLIGLUSAM DERIVED FROM ASPERGILLUS NIGER

A, E

When for oral use:

(a) the maximum recommended daily dose of the medicine must not provide more than 2000 mg of Poliglusam derived from Aspergillus niger;

(b) the following warning statement (or words to the same effect) is required on the medicine label:

- (CHITO) 'Poliglusam should be taken at least one hour after any other medication as it may reduce the effect of other medication.'; and

(c) if the medicine is a powdered dosage form, the following warning statement is also required on the medicine label:

- (DNTPOW) 'Do not take powder alone. Mix with food or fluid.'

When used as an excipient, Poliglusam derived from Aspergillus niger is only permitted for use in topical medicines for dermal application.

3960

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.

3961

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).

3962

POLOXAMER

E

Only for use in topical medicines for dermal application.

3963

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%.

3964

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%.

3965

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%.

3966

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%.

3967

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%.

3968

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%.

3969

POLYACRYLIC ACID

E

3970

POLYAMINO SUGAR CONDENSATE

E

Only for use in topical medicines for dermal application.

3971

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%.

3972

POLYBUTADIENE

E

Only for use as part of an adhesive in topical medicines for dermal application.

3973

POLYBUTENE

E

Only for use in topical medicines for dermal application.

3974

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%.

3975

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%.

3976

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%.

3977

POLYDEXTROSE

E

3978

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%.

3979

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%

3980

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%.

3981

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%.

3982

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%.

3983

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%.

3984

POLYETHYLENE

E

3985

POLYGALA CHINENSIS

A, H

3986

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.

3987

POLYGALA SIBIRICA

A, E, H

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

3988

POLYGALA TENUIFOLIA

A

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

3989

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%.

3990

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%.

3991

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%.

3992

POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE

E

Only for use in topical medicines for dermal application. 

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

3993

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%.

3994

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%.

3995

POLYGLYCERYL-2-PEG-4 STEARATE

E

Only for use in topical medicines for dermal application.

3996

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%.

3997

POLYGLYCERYL-3 DIISOSTEARATE

E

Only for use in topical medicines for dermal application.

3998

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%.

3999

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%.

4000

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%.

4001

POLYGLYCERYL-3 POLYRICINOLEATE

E

4002

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%.

4003

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%.

4004

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%.

4005

POLYGLYCERYL-4 OLEATE

E

Only for use in topical medicines for dermal application.

4006

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%.

4007

POLYGLYCERYL-6 RICINOLEATE

E

Only for use in topical medicines for dermal application.

4008

POLYGONATUM MULTIFLORUM

A, H

4009

POLYGONATUM OFFICINALE

A, H

4010

POLYGONATUM SIBIRICUM

A, E, H

4011

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%.

4012

POLYGONUM BISTORTA

A, H

4013

POLYGONUM ODORATUM

A, H

4014

POLYHYDROXYSTEARIC ACID

E

Only for use in topical medicines for dermal application.

4015

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.

4016

POLYISOPRENE

E

Only for use in topical medicines for dermal application.

4017

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%.

4018

POLYMETHACRYLIC ACID

E

4019

POLYMETHYL METHACRYLATE

E

Methyl methacrylate is a mandatory component of polymethyl methacrylate.

Only for use in topical medicines for dermal application.

The total concentration of methyl methacrylate as residual monomer in the medicine must not be more than 1%.

4020

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%.

4021

POLYPORUS UMBELLATUS

A, H

4022

POLYPROPYLENE

E

Only for use in topical medicines for dermal application.

4023

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%.

4024

POLYQUATERNIUM-10

E

Only for use in topical medicines for dermal application.

4025

POLYQUATERNIUM-11

E

Only for use in topical medicines for dermal application.

4026

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%.

4027

POLYQUATERNIUM-24

E

Only for use in topical medicines for dermal application.

4028

POLYQUATERNIUM-28

E

Only for use in topical medicines for dermal application.

4029

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%.

4030

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%.

4031

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%.

4032

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%.

4033

POLYQUATERNIUM-7

E

Only for use in topical medicines for dermal application.

4034

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%

4035

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%.

4036

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).

4037

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%.

4038

POLYSORBATE 20

E

4039

POLYSORBATE 40

E

4040

POLYSORBATE 60

E

4041

POLYSORBATE 65

E

4042

POLYSORBATE 80

E

4043

POLYSORBATE 85

E

Only for use in topical medicines for dermal application.

4044

POLYSTYRENE

E

Only for use as part of an adhesive in topical medicines for dermal application.

4045

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%.

4046

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.

4047

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%.

4048

POLYVINYL ACETATE

E

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

4049

POLYVINYL ACETATE PHTHALATE

E

4050

POLYVINYL ALCOHOL

E

4051

POLYVINYL CHLORIDE

E

Only for use in topical medicines for dermal application.

4052

POMEGRANATE

E

4053

PONCEAU SX

E

Permitted for use only as a colour for topical use.

4054

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.

4055

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%.

4056

PONTEDERIA CRASSIPES

A, H

4057

POPPY SEED

E, H

4058

POPPY SEED OIL

E, H

4059

POPULUS ALBA

A, H

4060

POPULUS BALSAMIIFERA

A, E, H

4061

POPULUS CANDICANS

A, H

4062

POPULUS DELTOIDES

A, H

4063

POPULUS NIGRA

A, H

4064

POPULUS TREMULA

A, H

4065

POPULUS TREMULOIDES

A, H

4066

PORCINE

H

Only for use as an active homoeopathic ingredient. 

4067

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%.

4068

PORTULACA OLERACEA

A, E, H

4069

POTABLE WATER

E

4070

POTASSIUM ACETATE

E

4071

POTASSIUM ARSENITE

H

Only for use as an active homoeopathic ingredient.

4072

POTASSIUM ASCORBATE

A, E, H

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

4073

POTASSIUM ASCORBATE DIHYDRATE

A, E, H

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

4074

POTASSIUM ASCORBYL TOCOPHERYL PHOSPHATE

E

Only for use in topical medicines for dermal application.

4075

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.

4076

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.

4077

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.

4078

POTASSIUM BICARBONATE

E

4079

POTASSIUM BROMIDE

H

Only for use as an active homoeopathic ingredient.

The total concentration of potassium bromide in the medicine must not be more than 10 mg/kg or 10 mg/L or 0.001%.

4080

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.

4081

POTASSIUM CETYL PHOSPHATE

E

Only for use in topical medicines for dermal application.

4082

POTASSIUM CHLORIDE

A, E, H

When for oral use:

(a) potassium is a mandatory component of potassium chloride;

(b) the medicine requires the following warning statement on the medicine label:

- (POTAS1) 'If you have kidney disease or are taking heart or blood pressure medicines - consult your doctor or pharmacist before use. Keep out of reach of children.'; and

(c) except when the medicine is for use as oral rehydration therapy, the amount of potassium chloride per dosage unit must not be more than 550 mg.

Medicines containing potassium chloride for use as oral rehydration therapy, are subject to the following conditions:

(a) the medicine complies with the requirements specified in the British Pharmacopoeia, as in force or existing from time to time, for Oral Rehydration Salts;

(b) the sodium, potassium and glucose content, and total osmolarity of the solution after it has been prepared according to the instructions on the packet are consistent with the criteria specified by the World Health Organisation (WHO) and the United Nations Children's Fund (UNICEF) in the document 'Expert consultation on oral rehydration salts formulation' 18 July 2001; and

(c) the following warning statements are required on the medicine label:

- (UOAD) 'Use only as directed'

- (DIAR3) 'If diarrhoea persists, seek medical advice.'

When for dental use, the concentration of potassium chloride in the medicine must not be more than 3.75%.

4083

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.

4084

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%.

4085

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%.

4086

POTASSIUM DICHROMATE

H

Only for use as an active homoeopathic ingredient.

4087

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.

4088

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.

4089

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.

4090

POTASSIUM HYDROXYCITRATE

A, H

4091

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.

4092

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%.

4093

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%.

4094

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%.

4095

POTASSIUM NITRATE

A, H

Only for dental use.

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

4096

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.

4097

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%.

4098

POTASSIUM SORBATE

E

4099

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%.

4100

POTASSIUM STEARATE

E

Only for use in topical medicines for dermal application.

4101

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.

4102

POTATO STARCH

E

4103

POTENTILLA ANSERINA

A, H

4104

POTENTILLA CHINENSIS

A, H

4105

POTENTILLA DISCOLOR

A, H

4106

POTENTILLA ERECTA

A, E, H

4107

POTENTILLA REPTANS

A, H

4108

POTERIUM OFFICINALE

A, E, H

4109

POTERIUM SANGUISORBA

A, H

4110

POVIDONE

E

4111

POWDERED CELLULOSE

E

4112

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%.

4113

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%.

4114

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%.

4115

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%.

4116

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%.

4117

PPG-2 LANOLIN ALCOHOL ETHER

E

Only for use in topical medicines for dermal application.

4118

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%.

4119

PPG-20 LANOLIN ALCOHOL ETHER

E

Only for use in topical medicines for dermal application.

4120

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%.

4121

PPG-20 METHYL GLUCOSE ETHER DISTEARATE

E

Only for use in topical medicines for dermal application.

4122

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%.

4123

PPG-3 MYRISTYL ETHER

E

Only for use in topical medicines for dermal application.

4124

PPG-5-CETETH-20

E

Only for use in topical medicines for dermal application.

4125

PPG-5-LAUROMACROGOL 250

E

Only for use in topical medicines for dermal application.

4126

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%.

4127

PREGELATINISED MAIZE STARCH

E

4128

PREGELATINISED POTATO STARCH

E

4129

PREGELATINISED RICE STARCH

E

4130