Permissible ingredients and requirements

Column 1

Column 2

Column 3

Column 4

Item

Ingredient Name

Purpose

Specific requirements

3636

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%.

3637

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%.

3638

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).

3639

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%.

3640

PAEONIA LACTIFLORA

A, E, H

3641

PAEONIA OBOVATA

A, H

3642

PAEONIA SUFFRUTICOSA

A, E, H

3643

PAEONIA VEITCHII

A, H

3644

PALIURUS SPINA-CHRISTI

A, H

3645

PALLADIUM

H

Only for use as an active homoeopathic ingredient.

3646

PALM FRUIT OIL

A, E, H

3647

PALM GLYCERIDES

E

3648

PALM KERNEL OIL

A, E, H

3649

PALM TOCOTRIENOLS COMPLEX

A, H

3650

PALMARIA PALMATA

A, H

3651

PALMAROSA OIL

A, E, H

3652

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.’

3653

PALMITIC ACID

E

3654

PALMITOLEIC ACID-RICH FATTY ACID ETHYL ESTERS

A

3655

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%.

3656

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%

3657

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%.

3658

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%.

3659

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%.

3660

PANAX GINSENG

A, E, H

3661

PANAX JAPONICUS

A, H

3662

PANAX NOTOGINSENG

A, H

3663

PANAX PSEUDOGINSENG

A, H

3664

PANAX QUINQUEFOLIUS

A, H

3665

PANICUM MILIACEUM

A, H

3666

PANTETHINE

E

Only for use in topical medicines for dermal application.

3667

PANTHENOL

A, E

3668

PANTHENYL ETHYL ETHER

E

Only for use in topical medicines for dermal application.

3669

PANTOLACTONE

E

3670

PANTOTHENIC ACID

A, E

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

3671

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%.

3672

PAPAIN

A, E

3673

PAPER

E

Only for use in topical medicines for dermal application.

3674

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%.

3675

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%.

3676

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%.

3677

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%.

3678

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%.

3679

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%.

3680

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%.

3681

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.

3682

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%.

3683

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%.

3684

PARA-HYDROXYBENZOIC ACID

E

3685

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%.

3686

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%.

3687

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%.

3688

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%.

3689

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.

3690

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%.

3691

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%.

3692

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%.

3693

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%.

3694

PARAMERIA LAEVIGATA

A, H

3695

PARIETARIA JUDAICA

A, H

3696

PARIS POLYPHYLLA

A, H

3697

PARIS QUADRIFOLIA

A, H

3698

PARSLEY HERB DRY

A, E, H

3699

PARSLEY HERB OIL

A, E, H

3700

PARSLEY HERB POWDER

A, E, H

3701

PARSLEY SEED OIL

A, E, H

3702

PARTHENOCISSUS TRICUSPIDATA

A, H

3703

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.

3704

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%.

3705

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%.

3706

PASPALUM NOTATUM

A, H

3707

PASSIFLORA CAERULEA

A, H

3708

PASSIFLORA EDULIS

E

3709

PASSIFLORA HERB DRY

A, H

3710

PASSIFLORA INCARNATA

A, E, H

3711

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%.

3712

PATENT BLUE V

E

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

3713

PATENT BLUE V ALUMINIUM LAKE

E

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

3714

PATRINIA SCABIOSIFOLIA

A, H

3715

PATRINIA VILLOSA

A, H

3716

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).

3717

PAULLINIA PINNATA

A, H

3718

PAWPAW

E

3719

PEA

E

3720

PEA STARCH

E

3721

PEACH

E

3722

PEAR

E

3723

PECAN

E

3724

PECTIN

A, E

3725

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%.

3726

PEG-10 SOYA STEROL

E

Only for use in topical medicines for dermal application.

3727

PEG-100 STEARATE

E

Only for use in topical medicines for dermal application.

3728

PEG-12 DILAURATE

E

3729

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%.

3730

PEG-120 METHYL GLUCOSE DIOLEATE

E

Only for use in topical medicines for dermal application.

3731

PEG-120 STEARATE

E

Only for use in topical medicines for dermal application.

3732

PEG-15 COCAMINE

E

Only for use in topical medicines for dermal application.

3733

PEG-150 DISTEARATE

E

Only for use in topical medicines for dermal application.

3734

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%.

3735

PEG-20 METHYL GLUCOSE DISTEARATE

E

Only for use in topical medicines for dermal application.

3736

PEG-20 METHYL GLUCOSE SESQUISTEARATE

E

Only for use in topical medicines for dermal application.

3737

PEG-20 SORBITAN ISOSTEARATE

E

Only for use in topical medicines for dermal application.

3738

PEG-20 STEARATE

E

Only for use in topical medicines for dermal application.

3739

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).

3740

PEG-30 DIPOLYHYDROXYSTEARATE

E

Only for use in topical medicines for dermal application.

3741

PEG-30 STEARATE

E

Only for use in topical medicines for dermal application.

3742

PEG-35 CASTOR OIL

E

3743

PEG-4 DILAURATE

E

Only for use in topical medicines for dermal application.

3744

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%.

3745

PEG-4 STEARATE

E

Only for use in topical medicines for dermal application.

3746

PEG-40 CASTOR OIL

E

3747

PEG-40 HYDROGENATED CASTOR OIL

E

3748

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%.

3749

PEG-40 STEARATE

E

Only for use in topical medicines for dermal application.

3750

PEG-45/DODECYL GLYCOL COPOLYMER

E

Only for use in topical medicines for dermal application.

3751

PEG-5 GLYCERYL STEARATE

E

Only for use in topical medicines for dermal application.

3752

PEG-50 STEARATE

E

Only for use in topical medicines for dermal application.

3753

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%.

3754

PEG-6 LAURAMIDE

E

Only for use in topical medicines for dermal application.

3755

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%.

3756

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%.

3757

PEG-60 HYDROGENATED CASTOR OIL

E

Only for use in topical medicines for dermal application.

3758

PEG-7 COCAMIDE

E

Only for use in topical medicines for dermal application.

3759

PEG-7 GLYCERYL COCOATE

E

Only for use in topical medicines for dermal application.

3760

PEG-7 HYDROGENATED CASTOR OIL

E

Only for use in topical medicines for dermal application.

3761

PEG-75 LANOLIN

E

Only for use in topical medicines for dermal application.

3762

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%.

3763

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%.

3764

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%.

3765

PEG-8 DISTEARATE

E

Only for use in topical medicines for dermal application.

3766

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.

3767

PEG-8 PROPYLENE GLYCOL COCOATE

E

3768

PEG-8 STEARATE

E

Only for use in topical medicines for dermal application.

3769

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%.

3770

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%.

3771

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%.

3772

PELARGONIUM GRAVEOLENS

A, E, H

3773

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%.

3774

PELTIGERA CANINA

A, H

3775

PENICILLIUM EXPANSUM

A, H

3776

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.

3777

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%

3778

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%.

3779

PENTAERYTHRITYL TETRALAURATE

E

Only for use in topical medicines for dermal application.

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

3780

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%.

3781

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%.

3782

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%.

3783

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%.

3784

PEPPER BLACK

E, H

3785

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%.

3786

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.

3787

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.

3788

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.

3789

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.

3790

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.

3791

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.

3792

PERFLUOROPOLYMETHYLISOPROPYL ETHER

E

Only for use in topical medicines for dermal application.

3793

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%.

3794

PERILLA FRUTESCENS

A, E, H

3795

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%.

3796

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%.

3797

PERMETHRIN

E

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

3798

PERSEA AMERICANA

A, E, H

3799

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%.

3800

PERSICARIA CHINENSIS

A, H

3801

PERSICARIA TINCTORIA

A, H

3802

PERU BALSAM

A, E, H

3803

PERU BALSAM OIL

A, E, H

3804

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%

3805

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%.

3806

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%.

3807

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.

3808

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%.

3809

PETROSELINUM CRISPUM

A, E, H

3810

PEUCEDANUM PRAERUPTORUM

A, E, H

3811

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).

3812

PHALARIS ARUNDINACEA

A, H

3813

PHALARIS CANARIENSIS

A, H

3814

PHASEOLUS COCCINEUS

A, H

3815

PHASEOLUS VULGARIS

A, H

3816

PHELLINUS ROBINIAE

A, E, H

3817

PHELLODENDRON AMURENSE

A, E, H

3818

PHELLODENDRON CHINENSE

A, H

3819

PHENACETIN

E

Only for use in topical medicines for dermal application.

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

3820

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%.

3821

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%.

3822

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%.

3823

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%.

3824

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%

3825

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%.

3826

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%.

3827

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%.

3828

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%.

3829

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%.

3830

PHENOL

E

Only for use in topical medicines for dermal application.

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

3831

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%.

3832

PHENOXYETHANOL

E

Only for use in topical medicines for dermal application.

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

3833

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%.

3834

PHENOXYETHYLPARABEN

E

Only for use in topical medicines for dermal application.

3835

PHENYL DIMETHICONE

E

Only for use in topical medicines for dermal application.

3836

PHENYL TRIMETHICONE

E

Only for use in topical medicines for dermal application.

3837

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%.

3838

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%.

3839

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%.

3840

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%.

3841

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'.

3842

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).

3843

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%.

3844

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%.

3845

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%.

3846

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%.

3847

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%.

3848

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%.

3849

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%.

3850

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%.

3851

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%.

3852

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%.

3853

PHLEUM PRATENSE

A, H

Only permitted in preparations other than phleum pratense pollen extract.

3854

PHLOXINE B

E

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

3855

PHLOXINE B ALUMINIUM LAKE

E

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

3856

PHOENIX DACTYLIFERA

A, E, H

3857

PHOSPHATIDYL CHOLINE

E

3858

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%.

3859

PHOSPHORIC ACID

E, H

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

3860

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%.

3861

PHOTINIA SERRULATA

A, H

3862

PHRAGMITES AUSTRALIS

A, H

3863

PHYLLANTHUS AMARUS

A, H

3864

PHYLLANTHUS EMBLICA

A, E, H

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

3865

PHYLLOSTACHYS NIGRA

A, E, H

3866

PHYSALIS ALKEKENGI

A, H

3867

PHYSALIS PUBESCENS

A, H

3868

PHYTANTRIOL

E

Only for use in topical medicines for dermal application.

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

3869

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%.

3870

PHYTOLACCA AMERICANA

A, H

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

3871

PHYTOMENADIONE

A, E

3872

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%.

3873

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%.

3874

PICEA ABIES

A, H

3875

PICEA MARIANA

A, H

3876

PICRASMA EXCELSA

A, E, H

3877

PICRORRHIZA KURROA

A, E, H

3878

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%.

3879

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%.

3880

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%.

3881

PIGMENT RED 4

E

Permitted for use only as a colour for topical use.

3882

PIGMENT RED 53

E

Permitted for use only as a colour for topical use.

3883

PIGMENT RED 57

E

Permitted for use only as a colour for topical use.

3884

PIGMENT RED 57 ALUMINIUM LAKE

E

Permitted for use only as a colour for topical use.

3885

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.

3886

PIGMENT RED 63

E

Permitted for use only as a colour for topical use.

3887

PIGMENT WHITE 26

E

Permitted for use only as a colour for topical use.

3888

PIGMENT YELLOW 12

E

Permitted for use only as a colour for topical use.

3889

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%.

3890

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%.

3891

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%.

3892

PIMENTA FRUIT OIL

A, E, H

3893

PIMENTA LEAF OIL

A, E, H

3894

PIMENTA OFFICINALIS

A, E, H

3895

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'.

3896

PIMPINELLA ANISUM

A, E, H

When the plant preparation for Pimpinella anisum is an oil or distillate and the concentration of this oil or distillate in the medicine is more than 50%:

a) the nominal capacity of the container must not be more than 50 millilitres; and

b) a restricted flow insert must be fitted on the container; and

c) the medicine requires the following warning statement on the medicine label:

- (CHILD) ‘Keep out of reach of children’ (or words to that effect).

3897

PIMPINELLA SAXIFRAGA

A, E, H

3898

PINE NEEDLE OIL SCOTCH

A, E, H

3899

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%.

3900

PINE OIL AROMATIC

A, E, H

3901

PINE OIL PUMILIO

A, E, H

3902

PINEAPPLE

E

3903

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%.

3904

PINELLIA TERNATA

A, H

3905

PINUS CONTORTA

A, E, H

3906

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%.

3907

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%.

3908

PINUS MONTICOLA

A, E, H

3909

PINUS MUGO

A, E, H

3910

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%.

3911

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%.

3912

PINUS PONDEROSA

A, E, H

3913

PINUS RADIATA

A, E, H

3914

PINUS STROBUS

A, E, H

3915

PINUS SYLVESTRIS

A, E, H

3916

PINUS TABULIFORMIS

A, E, H

3917

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%.

3918

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%.

3919

PIPER CHABA

A, E, H

3920

PIPER CUBEBA

A, E, H

3921

PIPER KADSURA

A, E, H

3922

PIPER LONGUM

A, E, H

3923

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.

3924

PIPER NIGRUM

A, E, H

3925

PIPER SARMENTOSUM

A, E, H

3926

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%.

3927

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%.

3928

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%.

3929

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%.

3930

PIPERONYL BUTOXIDE

E

Only for use in topical medicines for dermal application.

3931

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.

3932

PISCIDIA PISCIPULA

A, E, H

3933

PISTACIA LENTISCUS

A, E, H

3934

PISUM SATIVUM

A, E, H

3935

PLACENTA

H

Only for use as an active homoeopathic ingredient.

3936

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).

3937

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).

3938

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).

3939

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).

3940

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).

3941

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).

3942

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).

3943

PLATANUS OCCIDENTALIS

A, E, H

3944

PLATANUS RACEMOSA

A, H

3945

PLATANUS × HISPANICA

A, H

3946

PLATYCODON GRANDIFLORUS

A, E, H

3947

PLECTRANTHUS BARBATUS

A, E, H

3948

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%.

3949

PLUM

E

3950

PLUMBAGO EUROPAEA

A, H

3951

PLUMERIA ALBA

A, E, H

3952

PLUMERIA RUBRA

A, E, H

3953

POA NEMORALIS

A, H

3954

POA PRATENSIS

A, H

3955

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%.

3956

POGOSTEMON CABLIN

A, E, H

3957

POLACRILIN

E

3958

POLACRILIN POTASSIUM

E

3959

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).

3960

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.

3961

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.

3962

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.

3963

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).

3964

POLOXAMER

E

Only for use in topical medicines for dermal application.

3965

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%.

3966

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%.

3967

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%.

3968

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%.

3969

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%.

3970

POLYACRYLIC ACID

E

3971

POLYAMINO SUGAR CONDENSATE

E

Only for use in topical medicines for dermal application.

3972

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%.

3973

POLYBUTADIENE

E

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

3974

POLYBUTENE

E

Only for use in topical medicines for dermal application.

3975

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%.

3976

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%.

3977

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%.

3978

POLYDEXTROSE

E

3979

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%.

3980

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%

3981

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%.

3982

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%.

3983

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%.

3984

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%.

3985

POLYETHYLENE

E

3986

POLYGALA CHINENSIS

A, H

3987

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.

3988

POLYGALA SIBIRICA

A, E, H

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

3989

POLYGALA TENUIFOLIA

A

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

3990

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%.

3991

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%.

3992

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%.

3993

POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE

E

Only for use in topical medicines for dermal application. 

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

3994

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%.

3995

POLYGLYCERYL-2 ISOSTEARATE

E

Polyglyceryl-2 isostearate must:

(a) Only be used in topical medicines for dermal application; and

(b) Not be included in medicines intended for use on broken skin or in the eye.

The concentration in the medicine must be no more than 2.5%.

3996

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%.

3997

POLYGLYCERYL-2-PEG-4 STEARATE

E

Only for use in topical medicines for dermal application.

3998

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%.

3999

POLYGLYCERYL-3 DIISOSTEARATE

E

Only for use in topical medicines for dermal application.

4000

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%.

4001

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%.

4002

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%.

4003

POLYGLYCERYL-3 POLYRICINOLEATE

E

4004

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%.

4005

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%.

4006

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%.

4007

POLYGLYCERYL-4 OLEATE

E

Only for use in topical medicines for dermal application.

4008

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%.

4009

POLYGLYCERYL-6 RICINOLEATE

E

Only for use in topical medicines for dermal application.

4010

POLYGONATUM MULTIFLORUM

A, H

4011

POLYGONATUM OFFICINALE

A, H

4012

POLYGONATUM SIBIRICUM

A, E, H

4013

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%.

4014

POLYGONUM BISTORTA

A, H

4015

POLYGONUM ODORATUM

A, H

4016

POLYHYDROXYSTEARIC ACID

E

Only for use in topical medicines for dermal application.

4017

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.

4018

POLYISOPRENE

E

Only for use in topical medicines for dermal application.

4019

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%.

4020

POLYMETHACRYLIC ACID

E

4021

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%.

4022

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%.

4023

POLYPORUS UMBELLATUS

A, H

4024

POLYPROPYLENE

E

Only for use in topical medicines for dermal application.

4025

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%.

4026

POLYQUATERNIUM-10

E

Only for use in topical medicines for dermal application.

4027

POLYQUATERNIUM-11

E

Only for use in topical medicines for dermal application.

4028

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%.

4029

POLYQUATERNIUM-24

E

Only for use in topical medicines for dermal application.

4030

POLYQUATERNIUM-28

E

Only for use in topical medicines for dermal application.

4031

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%.

4032

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%.

4033

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%.

4034

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%.

4035

POLYQUATERNIUM-7

E

Only for use in topical medicines for dermal application.

4036

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%

4037

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%.

4038

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).

4039

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%.

4040

POLYSORBATE 20

E

4041

POLYSORBATE 40

E

4042

POLYSORBATE 60

E

4043

POLYSORBATE 65

E

4044

POLYSORBATE 80

E

4045

POLYSORBATE 85

E

Only for use in topical medicines for dermal application.

4046

POLYSTYRENE

E

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

4047

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%.

4048

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.

4049

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%.

4050

POLYVINYL ACETATE

E

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

4051

POLYVINYL ACETATE PHTHALATE

E

4052

POLYVINYL ALCOHOL

E

4053

POLYVINYL CHLORIDE

E

Only for use in topical medicines for dermal application.

4054

POMEGRANATE

E

4055

PONCEAU SX

E

Permitted for use only as a colour for topical use.

4056

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.

4057

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%.

4058

PONTEDERIA CRASSIPES

A, H

4059

POPPY SEED

E, H

4060

POPPY SEED OIL

E, H

4061

POPULUS ALBA

A, H

4062

POPULUS BALSAMIIFERA

A, E, H

4063

POPULUS CANDICANS

A, H

4064

POPULUS DELTOIDES

A, H

4065

POPULUS NIGRA

A, H

4066

POPULUS TREMULA

A, H

4067

POPULUS TREMULOIDES

A, H

4068

PORCINE

H

Only for use as an active homoeopathic ingredient. 

4069

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%.

4070

PORTULACA OLERACEA

A, E, H

4071

POTABLE WATER

E

4072

POTASSIUM ACETATE

E

4073

POTASSIUM ARSENITE

H

Only for use as an active homoeopathic ingredient.

4074

POTASSIUM ASCORBATE

A, E, H

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

4075

POTASSIUM ASCORBATE DIHYDRATE

A, E, H

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

4076

POTASSIUM ASCORBYL TOCOPHERYL PHOSPHATE

E

Only for use in topical medicines for dermal application.

4077

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.

4078

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.

4079

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.

4080

POTASSIUM BICARBONATE

E

4081

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%.

4082

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.

4083

POTASSIUM CETYL PHOSPHATE

E

Only for use in topical medicines for dermal application.

4084

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%.

4085

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.

4086

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%.

4087

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%.

4088

POTASSIUM DICHROMATE

H

Only for use as an active homoeopathic ingredient.

4089

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.

4090

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.

4091

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.

4092

POTASSIUM HYDROXYCITRATE

A, H

4093

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.

4094

POTASSIUM IODIDE

A, E, H

Iodine is a mandatory component of potassium iodide.

The percentage of iodine from potassium iodide should be calculated based on the molecular weight of potassium iodide.

When for internal use, the maximum recommended daily dose of the medicine must contain less than 300 micrograms of iodine.

When for external use, the concentration of iodine in the medicine (excluding salt derivatives or iodophors) must not exceed 2.5%.

4095

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%.

4096

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%.

4097

POTASSIUM NITRATE

A, H

Only for dental use.

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

4098

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.

4099

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%.

4100

POTASSIUM SORBATE

E

4101

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%.

4102

POTASSIUM STEARATE

E

Only for use in topical medicines for dermal application.

4103

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.

4104

POTATO STARCH

E

4105

POTENTILLA ANSERINA

A, H

4106

POTENTILLA CHINENSIS

A, H

4107

POTENTILLA DISCOLOR

A, H

4108

POTENTILLA ERECTA

A, E, H

4109

POTENTILLA REPTANS

A, H

4110

POTERIUM OFFICINALE

A, E, H

4111

POTERIUM SANGUISORBA

A, H

4112

POVIDONE

E

4113

POWDERED CELLULOSE

E

4114

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%.

4115

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%.

4116

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%.

4117

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%.

4118

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%.

4119

PPG-2 LANOLIN ALCOHOL ETHER

E

Only for use in topical medicines for dermal application.

4120

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%.

4121

PPG-20 LANOLIN ALCOHOL ETHER

E

Only for use in topical medicines for dermal application.

4122

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%.

4123

PPG-20 METHYL GLUCOSE ETHER DISTEARATE

E

Only for use in topical medicines for dermal application.

4124

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%.

4125

PPG-3 MYRISTYL ETHER

E

Only for use in topical medicines for dermal application.

4126

PPG-5-CETETH-20

E

Only for use in topical medicines for dermal application.

4127

PPG-5-LAUROMACROGOL 250

E

Only for use in topical medicines for dermal application.

4128

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%.

4129

PREGELATINISED MAIZE STARCH

E

4130

PREGELATINISED POTATO STARCH

E

4131

PREGELATINISED RICE STARCH

E