Schedule 1—Specified permissible ingredients and requirements applying to these ingredients when contained in a medicine

Note: See sections 5 and 6.

Permissible ingredients and requirements

Column 1

Column 2

Column 3

Column 4

Item

Ingredient Name

Purpose

Specific requirements

3635

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%.

 

3636

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%.

 

3637

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).

 

3638

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%.

 

3639

PAEONIA LACTIFLORA

A, E, H

 

3640

PAEONIA OBOVATA

A, H

 

3641

PAEONIA SUFFRUTICOSA

A, E, H

 

3642

PAEONIA VEITCHII

A, H

 

3643

PALIURUS SPINA-CHRISTI

A, H

 

3644

PALLADIUM

H

Only for use as an active homoeopathic ingredient.

 

3645

PALM FRUIT OIL

A, E, H

 

3646

PALM GLYCERIDES

E

 

3647

PALM KERNEL OIL

A, E, H

 

3648

PALM TOCOTRIENOLS COMPLEX

A, H

 

3649

PALMARIA PALMATA

A, H

 

3650

PALMAROSA OIL

A, E, H

 

3651

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.’

 

3652

PALMITIC ACID

E

 

3653

PALMITOLEIC ACID-RICH FATTY ACID ETHYL ESTERS

A

 

3654

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%.

 

3655

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%

 

3656

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%.

 

3657

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%.

 

3658

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%.

 

3659

PANAX GINSENG

A, E, H

 

3660

PANAX JAPONICUS

A, H

 

3661

PANAX NOTOGINSENG

A, H

 

3662

PANAX PSEUDOGINSENG

A, H

 

3663

PANAX QUINQUEFOLIUS

A, H

 

3664

PANICUM MILIACEUM

A, H

 

3665

PANTETHINE

E

Only for use in topical medicines for dermal application.

 

3666

PANTHENOL

A, E

 

3667

PANTHENYL ETHYL ETHER

E

Only for use in topical medicines for dermal application.

 

3668

PANTOLACTONE

E

 

3669

PANTOTHENIC ACID

A, E

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

 

3670

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%.

 

3671

PAPAIN

A, E

 

3672

PAPER

E

Only for use in topical medicines for dermal application.

 

3673

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%.

 

3674

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%.

 

3675

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%.

 

3676

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%.

 

3677

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%.

 

3678

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%.

 

3679

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%.

 

3680

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.

 

3681

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%.

 

3682

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%.

 

3683

PARA-HYDROXYBENZOIC ACID

E

 

3684

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%.

 

3685

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%.

 

3686

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%.

 

3687

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%.

 

3688

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.

 

3689

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%.

 

3690

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%.

 

3691

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%.

 

3692

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%.

 

3693

PARAMERIA LAEVIGATA

A, H

 

3694

PARIETARIA JUDAICA

A, H

 

3695

PARIS POLYPHYLLA

A, H

 

3696

PARIS QUADRIFOLIA

A, H

 

3697

PARSLEY HERB DRY

A, E, H

 

3698

PARSLEY HERB OIL

A, E, H

 

3699

PARSLEY HERB POWDER

A, E, H

 

3700

PARSLEY SEED OIL

A, E, H

 

3701

PARTHENOCISSUS TRICUSPIDATA

A, H

 

3702

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.

 

3703

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%.

 

3704

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%.

 

3705

PASPALUM NOTATUM

A, H

 

3706

PASSIFLORA CAERULEA

A, H

 

3707

PASSIFLORA EDULIS

E

 

3708

PASSIFLORA HERB DRY

A, H

 

3709

PASSIFLORA INCARNATA

A, E, H

 

3710

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%.

 

3711

PATENT BLUE V

E

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

 

3712

PATENT BLUE V ALUMINIUM LAKE

E

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

 

3713

PATRINIA SCABIOSIFOLIA

A, H

 

3714

PATRINIA VILLOSA

A, H

 

3715

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).

 

3716

PAULLINIA PINNATA

A, H

 

3717

PAWPAW

E

 

3718

PEA

E

 

3719

PEA STARCH

E

 

3720

PEACH

E

 

3721

PEAR

E

 

3722

PECAN

E

 

3723

PECTIN

A, E

 

3724

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%.

 

3725

PEG-10 SOYA STEROL

E

Only for use in topical medicines for dermal application.

 

3726

PEG-100 STEARATE

E

Only for use in topical medicines for dermal application.

 

3727

PEG-12 DILAURATE

E

 

3728

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%.

 

3729

PEG-120 METHYL GLUCOSE DIOLEATE

E

Only for use in topical medicines for dermal application.

 

3730

PEG-120 STEARATE

E

Only for use in topical medicines for dermal application.

 

3731

PEG-15 COCAMINE

E

Only for use in topical medicines for dermal application.

 

3732

PEG-150 DISTEARATE

E

Only for use in topical medicines for dermal application.

 

3733

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%.

 

3734

PEG-20 METHYL GLUCOSE DISTEARATE

E

Only for use in topical medicines for dermal application.

 

3735

PEG-20 METHYL GLUCOSE SESQUISTEARATE

E

Only for use in topical medicines for dermal application.

 

3736

PEG-20 SORBITAN ISOSTEARATE

E

Only for use in topical medicines for dermal application.

 

3737

PEG-20 STEARATE

E

Only for use in topical medicines for dermal application.

 

3738

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).

 

3739

PEG-30 DIPOLYHYDROXYSTEARATE

E

Only for use in topical medicines for dermal application.

 

3740

PEG-30 STEARATE

E

Only for use in topical medicines for dermal application.

 

3741

PEG-35 CASTOR OIL

E

 

3742

PEG-4 DILAURATE

E

Only for use in topical medicines for dermal application.

 

3743

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%.

 

3744

PEG-4 STEARATE

E

Only for use in topical medicines for dermal application.

 

3745

PEG-40 CASTOR OIL

E

 

3746

PEG-40 HYDROGENATED CASTOR OIL

E

 

3747

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%.

 

3748

PEG-40 STEARATE

E

Only for use in topical medicines for dermal application.

 

3749

PEG-45/DODECYL GLYCOL COPOLYMER

E

Only for use in topical medicines for dermal application.

 

3750

PEG-5 GLYCERYL STEARATE

E

Only for use in topical medicines for dermal application.

 

3751

PEG-50 STEARATE

E

Only for use in topical medicines for dermal application.

 

3752

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%.

 

3753

PEG-6 LAURAMIDE

E

Only for use in topical medicines for dermal application.

 

3754

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%.

 

3755

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%.

 

3756

PEG-60 HYDROGENATED CASTOR OIL

E

Only for use in topical medicines for dermal application.

 

3757

PEG-7 COCAMIDE

E

Only for use in topical medicines for dermal application.

 

3758

PEG-7 GLYCERYL COCOATE

E

Only for use in topical medicines for dermal application.

 

3759

PEG-7 HYDROGENATED CASTOR OIL

E

Only for use in topical medicines for dermal application.

 

3760

PEG-75 LANOLIN

E

Only for use in topical medicines for dermal application.

 

3761

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%.

 

3762

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%.

 

3763

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%.

 

3764

PEG-8 DISTEARATE

E

Only for use in topical medicines for dermal application.

 

3765

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.

 

3766

PEG-8 PROPYLENE GLYCOL COCOATE

E

 

3767

PEG-8 STEARATE

E

Only for use in topical medicines for dermal application.

 

3768

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%.

 

3769

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%.

 

3770

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%.

 

3771

PELARGONIUM GRAVEOLENS

A, E, H

 

3772

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%.

 

3773

PELTIGERA CANINA

A, H

 

3774

PENICILLIUM EXPANSUM

A, H

 

3775

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.

 

3776

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%

 

3777

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%.

 

3778

PENTAERYTHRITYL TETRALAURATE

E

Only for use in topical medicines for dermal application.

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

 

3779

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%.

 

3780

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%.

 

3781

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%.

 

3782

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%.

 

3783

PEPPER BLACK

E, H

 

3784

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%.

 

3785

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.

 

3786

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.

 

3787

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.

 

3788

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.

 

3789

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.

 

3790

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.

 

3791

PERFLUOROPOLYMETHYLISOPROPYL ETHER

E

Only for use in topical medicines for dermal application.

 

3792

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%.

 

3793

PERILLA FRUTESCENS

A, E, H

 

3794

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%.

 

3795

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%.

 

3796

PERMETHRIN

E

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

 

3797

PERSEA AMERICANA

A, E, H

 

3798

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%.

 

3799

PERSICARIA CHINENSIS

A, H

 

3800

PERSICARIA TINCTORIA

A, H

 

3801

PERU BALSAM

A, E, H

 

3802

PERU BALSAM OIL

A, E, H

 

3803

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%

 

3804

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%.

 

3805

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%.

 

3806

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.

 

3807

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%.

 

3808

PETROSELINUM CRISPUM

A, E, H

 

3809

PEUCEDANUM PRAERUPTORUM

A, E, H

 

3810

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).

 

3811

PHALARIS ARUNDINACEA

A, H

 

3812

PHALARIS CANARIENSIS

A, H

 

3813

PHASEOLUS COCCINEUS

A, H

 

3814

PHASEOLUS VULGARIS

A, H

 

3815

PHELLINUS ROBINIAE

A, E, H

 

3816

PHELLODENDRON AMURENSE

A, E, H

 

3817

PHELLODENDRON CHINENSE

A, H

 

3818

PHENACETIN

E

Only for use in topical medicines for dermal application.

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

 

3819

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%.

 

3820

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%.

 

3821

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%.

 

3822

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%.

 

3823

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%

 

3824

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%.

 

3825

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%.

 

3826

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%.

 

3827

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%.

 

3828

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%.

 

3829

PHENOL

E

Only for use in topical medicines for dermal application.

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

 

3830

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%.

 

3831

PHENOXYETHANOL

E

Only for use in topical medicines for dermal application.

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

 

3832

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%.

 

3833

PHENOXYETHYLPARABEN

E

Only for use in topical medicines for dermal application.

 

3834

PHENYL DIMETHICONE

E

Only for use in topical medicines for dermal application.

 

3835

PHENYL TRIMETHICONE

E

Only for use in topical medicines for dermal application.

 

3836

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%.

 

3837

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%.

 

3838

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%.

 

3839

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%.

 

3840

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'.

 

3841

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).

 

3842

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%.

 

3843

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%.

 

3844

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%.

 

3845

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%.

 

3846

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%.

 

3847

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%.

 

3848

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%.

 

3849

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%.

 

3850

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%.

 

3851

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%.

 

3852

PHLEUM PRATENSE

A, H

 

3853

PHLOXINE B

E

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

 

3854

PHLOXINE B ALUMINIUM LAKE

E

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

 

3855

PHOENIX DACTYLIFERA

A, E, H

 

3856

PHOSPHATIDYL CHOLINE

E

 

3857

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%.

 

3858

PHOSPHORIC ACID

E, H

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

 

3859

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%.

 

3860

PHOTINIA SERRULATA

A, H

 

3861

PHRAGMITES AUSTRALIS

A, H

 

3862

PHYLLANTHUS AMARUS

A, H

 

3863

PHYLLANTHUS EMBLICA

A, E, H

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

 

3864

PHYLLOSTACHYS NIGRA

A, E, H

 

3865

PHYSALIS ALKEKENGI

A, H

 

3866

PHYSALIS PUBESCENS

A, H

 

3867

PHYTANTRIOL

E

Only for use in topical medicines for dermal application.

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

 

3868

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%.

 

3869

PHYTOLACCA AMERICANA

A, H

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

 

3870

PHYTOMENADIONE

A, E

 

3871

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%.

 

3872

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%.

 

3873

PICEA ABIES

A, H

 

3874

PICEA MARIANA

A, H

 

3875

PICRASMA EXCELSA

A, E, H

 

3876

PICRORRHIZA KURROA

A, E, H

 

3877

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%.

 

3878

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%.

 

3879

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%.

 

3880

PIGMENT RED 4

E

Permitted for use only as a colour for topical use.

 

3881

PIGMENT RED 53

E

Permitted for use only as a colour for topical use.

 

3882

PIGMENT RED 57

E

Permitted for use only as a colour for topical use.

 

3883

PIGMENT RED 57 ALUMINIUM LAKE

E

Permitted for use only as a colour for topical use.

 

3884

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.

 

3885

PIGMENT RED 63

E

Permitted for use only as a colour for topical use.

 

3886

PIGMENT WHITE 26

E

Permitted for use only as a colour for topical use.

 

3887

PIGMENT YELLOW 12

E

Permitted for use only as a colour for topical use.

 

3888

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%.

 

3889

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%.

 

3890

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%.

 

3891

PIMENTA FRUIT OIL

A, E, H

 

3892

PIMENTA LEAF OIL

A, E, H

 

3893

PIMENTA OFFICINALIS

A, E, H

 

3894

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'.

 

3895

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).

 

3896

PIMPINELLA SAXIFRAGA

A, E, H

 

3897

PINE NEEDLE OIL SCOTCH

A, E, H

 

3898

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%.

 

3899

PINE OIL AROMATIC

A, E, H

 

3900

PINE OIL PUMILIO

A, E, H

 

3901

PINEAPPLE

E

 

3902

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%.

 

3903

PINELLIA TERNATA

A, H

 

3904

PINUS CONTORTA

A, E, H

 

3905

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%.

 

3906

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%.

 

3907

PINUS MONTICOLA

A, E, H

 

3908

PINUS MUGO

A, E, H

 

3909

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%.

 

3910

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%.

 

3911

PINUS PONDEROSA

A, E, H

 

3912

PINUS RADIATA

A, E, H

 

3913

PINUS STROBUS

A, E, H

 

3914

PINUS SYLVESTRIS

A, E, H

 

3915

PINUS TABULIFORMIS

A, E, H

 

3916

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%.

 

3917

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%.

 

3918

PIPER CHABA

A, E, H

 

3919

PIPER CUBEBA

A, E, H

 

3920

PIPER KADSURA

A, E, H

 

3921

PIPER LONGUM

A, E, H

 

3922

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.

 

3923

PIPER NIGRUM

A, E, H

 

3924

PIPER SARMENTOSUM

A, E, H

 

3925

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%.

 

3926

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%.

 

3927

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%.

 

3928

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%.

 

3929

PIPERONYL BUTOXIDE

E

Only for use in topical medicines for dermal application.

 

3930

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.

 

3931

PISCIDIA PISCIPULA

A, E, H

 

3932

PISTACIA LENTISCUS

A, E, H

 

3933

PISUM SATIVUM

A, E, H

 

3934

PLACENTA

H

Only for use as an active homoeopathic ingredient.

 

3935

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).

 

3936

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).

 

3937

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).

 

3938

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).

 

3939

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).

 

3940

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).

 

3941

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).

 

3942

PLATANUS OCCIDENTALIS

A, E, H

 

3943

PLATANUS RACEMOSA

A, H

 

3944

PLATANUS × HISPANICA

A, H

 

3945

PLATYCODON GRANDIFLORUS

A, E, H

 

3946

PLECTRANTHUS BARBATUS

A, E, H

 

3947

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%.

 

3948

PLUM

E

 

3949

PLUMBAGO EUROPAEA

A, H

 

3950

PLUMERIA ALBA

A, E, H

 

3951

PLUMERIA RUBRA

A, E, H

 

3952

POA NEMORALIS

A, H

 

3953

POA PRATENSIS

A, H

 

3954

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%.

 

3955

POGOSTEMON CABLIN

A, E, H

 

3956

POLACRILIN

E

 

3957

POLACRILIN POTASSIUM

E

 

3958

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).

 

3959

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.

 

3960

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.

 

3961

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.

 

3962

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).

 

3963

POLOXAMER

E

Only for use in topical medicines for dermal application.

 

3964

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%.

 

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

PREGELATINISED STARCH

E

 

4131

PREGELATINISED WHEAT STARCH

E

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

 

4132

PRENYL ACETATE

E

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

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.

 

4133

PRICKLY ASH BARK DRY

A, H

 

4134

PRICKLY ASH BARK POWDER

A, H

 

4135

PRIMULA VERIS

A, E, H

 

4136

PRIMULA VULGARIS

A, E, H

 

4137

PRINSEPIA UNIFLORA

A, H

 

4138

PROBOSCIDEA PARVIFLORA

A, H

 

4139

PROGESTERONE

H

Only for use as an active homoeopathic ingredient.

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

 

4140

PROLINE

A, E

 

4141

PROPAN-1-OL

E

Only for use in:

- topical medicines for dermal application; or

- in combination with other permitted ingredients as a flavour proprietary excipient formulation.

The concentration of propan-1-ol in the medicine must not be more than 18%.

When used in medicines in combination with other permitted ingredients as a flavour proprietary excipient formulation, the total flavour proprietary excipient formulation in a medicine must not be more than 5%.

 

4142

PROPANE

E

Only for use as an excipient propellant ingredient.

 

4143

PROPANEDIOL

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%.

 

4144

PROPENYL GUAETHOL

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%.

 

4145

PROPIONALDEHYDE

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%.

 

4146

PROPIONIC 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%.

 

4147

PROPIONYLLEVOCARNITINE HYDROCHLORIDE

A, H

 

4148

PROPOLIS

A, E

Lead is a mandatory component of Propolis.

The concentration of lead in the medicine must be no more than 0.001%.

When used topically, the medicine requires the following warning statement on the medicine label:

-(PROP1) 'WARNING: Propolis may cause skin irritation. Test before use'

When used for other than for topical, the medicine requires the following warning statement on the medicine label:

- (PROP2) 'Warning: Propolis may cause allergic reactions. If irritation or swelling of the mouth or throat occurs, discontinue use.'

 

4149

PROPOLIS BALSAM

A, E

Lead is a mandatory component of Propolis balsam.

The concentration of lead in the medicine must be no more than 0.001%.

When used topically, the medicine requires the following warning statement on the medicine label:

-(PROP1) 'WARNING: Propolis may cause skin irritation. Test before use'

When used for other than for topical, the medicine requires the following warning statement on the medicine label:

- (PROP2) 'Warning: Propolis may cause allergic reactions. If irritation or swelling of the mouth or throat occurs, discontinue use.'

 

4150

PROPOLIS DRY EXTRACT

A, E

Lead is a mandatory component of Propolis dry extract.

The concentration of lead in the medicine must be no more than 0.001%.

When used topically, the medicine requires the following warning statement on the medicine label:

-(PROP1) 'WARNING: Propolis may cause skin irritation. Test before use'

When used for other than for topical, the medicine requires the following warning statement on the medicine label:

- (PROP2) 'Warning: Propolis may cause allergic reactions. If irritation or swelling of the mouth or throat occurs, discontinue use.'

 

4151

PROPOLIS LIQUID EXTRACT

A, E

Lead is a mandatory component of Propolis liquid extract.

The concentration of lead in the medicine must be no more than 0.001%.

When used topically, the medicine requires the following warning statement on the medicine label:

-(PROP1) 'WARNING: Propolis may cause skin irritation. Test before use'

When used for other than for topical, the medicine requires the following warning statement on the medicine label:

- (PROP2) 'Warning: Propolis may cause allergic reactions. If irritation or swelling of the mouth or throat occurs, discontinue use.'

 

4152

PROPOLIS RESIN

A, E

Lead is a mandatory component of propolis resin.

The concentration of lead in the medicine must be no more than 0.001%.

When used topically, the medicine requires the following warning statement on the medicine label:

-(PROP1) 'WARNING: Propolis may cause skin irritation. Test before use'

When used for other than for topical, the medicine requires the following warning statement on the medicine label:

- (PROP2) 'Warning: Propolis may cause allergic reactions. If irritation or swelling of the mouth or throat occurs, discontinue use.'

 

4153

PROPOLIS TINCTURE

A, E

Lead is a mandatory component of Propolis tincture.

The concentration of lead in the medicine must be no more than 0.001%.

When used topically, the medicine requires the following warning statement on the medicine label:

-(PROP1) 'WARNING: Propolis may cause skin irritation. Test before use'

When used for other than for topical, the medicine requires the following warning statement on the medicine label:

- (PROP2) 'Warning: Propolis may cause allergic reactions. If irritation or swelling of the mouth or throat occurs, discontinue use.'

 

4154

PROPYL 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%.

 

4155

PROPYL CAPROATE

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%.

 

4156

PROPYL GALLATE

E

 

4157

PROPYL HYDROXYBENZOATE

E

 

4158

PROPYLENE CARBONATE

E

Only for use in topical medicines for dermal application.

 

4159

PROPYLENE GLYCOL

E

 

4160

PROPYLENE GLYCOL ALGINATE

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%.

 

4161

PROPYLENE GLYCOL DIBENZOATE

E

Only for use in topical medicines for dermal application only and not to be used in topical medicines intended for use in the eye.

The concentration in the medicine must be no more than 20%.

 

4162

PROPYLENE GLYCOL DIDECANOATE

E

Only for use in topical medicines for dermal application only and not to be used in topical medicines intended for use in the eye.

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

 

4163

PROPYLENE GLYCOL DIOCTANOATE

E

Only for use in topical medicines for dermal application.

 

4164

PROPYLENE GLYCOL DIOCTANOATE/DIDECANOATE

E

Only for use in topical medicines for dermal application.

 

4165

PROPYLENE GLYCOL DIPELARGONATE

E

Only for use in topical medicines for dermal application.

 

4166

PROPYLENE GLYCOL ISOCETETH-3 ACETATE

E

Only for use in topical medicines for dermal application only and not to be used in topical medicines intended for use in the eye.

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

 

4167

PROPYLENE GLYCOL ISOSTEARATE

E

Only for use in topical medicines for dermal application.

 

4168

PROPYLENE GLYCOL MONOLAURATE

E

Only for use in topical medicines for dermal application.

 

4169

PROPYLENE GLYCOL MONOSTEARATE

E

Only for use in topical medicines for dermal application.

 

4170

PROPYLENE GLYCOL MYRISTYL ETHER ACETATE

E

Only for use in topical medicines for dermal application.

 

4171

PROSOPIS JULIFLORA

A, H

 

4172

PROTEASE

A

Must be derived from Aspergillus oryzae or Aspergillus niger.

 

4173

PROTEIN HYDROLYSATE

E

 

4174

PRUNE JUICE

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%.

 

4175

PRUNE JUICE CONCENTRATE

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%.

 

4176

PRUNELLA VULGARIS

A, H

 

4177

PRUNUS AFRICANA

A, E, H

Amygdalin and hydrocyanic acid are mandatory components of Prunus africana.

The concentration of Amygdalin in the medicine must be 0%.

The concentration of Hydrocyanic acid in the medicine must be no more than 1 microgram/kg or 1 microgram/L or 0.0000001%.

 

4178

PRUNUS ARMENIACA

A, E, H

Amygdalin and hydrocyanic acid are mandatory components of Prunus armeniaca and must be declared in the application.

The concentration of Amygdalin in the medicine must be 0%.

The concentration of Hydrocyanic acid in the medicine must be no more than 1 microgram/kg or 1 microgram/L or 0.0000001%.

 

4179

PRUNUS AVIUM

A, E, H

Amygdalin and hydrocyanic acid are mandatory components of Prunus avium.

The concentration of Amygdalin in the medicine must be 0%.

The concentration of Hydrocyanic acid in the medicine must be no more than 1 microgram/kg or 1 microgram/L or 0.0000001%.

 

4180

PRUNUS CERASIFERA

A, E, H

Amygdalin and hydrocyanic acid are mandatory components of Prunus cerasifera.

The concentration of Amygdalin in the medicine must be 0%.

The concentration of Hydrocyanic acid in the medicine must be no more than 1 microgram/kg or 1 microgram/L or 0.0000001%.

 

4181

PRUNUS CERASUS

A, E, H

Amygdalin and hydrocyanic acid are mandatory components of Prunus cerasus.

The concentration of Amygdalin in the medicine must be 0%.

The concentration of Hydrocyanic acid in the medicine must be no more than 1 microgram/kg or 1 microgram/L or 0.0000001%.

 

4182

PRUNUS DOMESTICA

A, E, H

Amygdalin and hydrocyanic acid are mandatory components of Prunus domestica.

The concentration of Amygdalin in the medicine must be 0%.

The concentration of Hydrocyanic acid in the medicine must be no more than 1 microgram/kg or 1 microgram/L or 0.0000001%.

 

4183

PRUNUS DULCIS

A, E, H

Amygdalin and hydrocyanic acid are mandatory components of Prunus dulcis when the plant part is seed.

When the plant part is seed, the maximum recommended daily dose must be no more than the equivalent of 1mg of the dry seed.

The concentration of Amygdalin in the medicine must be 0%.

The concentration of Hydrocyanic acid in the medicine must be no more than 1 microgram/kg or 1 microgram/L or 0.0000001%.

 

4184

PRUNUS HUMILIS

A, E, H

Amygdalin and hydrocyanic acid are mandatory components of Prunus humilis.

The concentration of Amygdalin in the medicine must be 0%.

The concentration of Hydrocyanic acid in the medicine must be no more than 1 microgram/kg or 1 microgram/L or 0.0000001%.

 

4185

PRUNUS JAPONICA

A, E, H

Amygdalin and hydrocyanic acid are mandatory components of Prunus japonica.

The concentration of Amygdalin in the medicine must be 0%.

The concentration of Hydrocyanic acid in the medicine must be no more than 1 microgram/kg or 1 microgram/L or 0.0000001%.

 

4186

PRUNUS LAUROCERASUS

A, E, H

Amygdalin and hydrocyanic acid are mandatory components of Prunus laurocerasus.

The concentration of Amygdalin in the medicine must be 0%.

The concentration of Hydrocyanic acid in the medicine must be no more than 1 microgram/kg or 1 microgram/L or 0.0000001%.

 

4187

PRUNUS MUME

A, E, H

Amygdalin and hydrocyanic acid are mandatory components of Prunus mume.

The concentration of Amygdalin in the medicine must be 0%.

The concentration of Hydrocyanic acid in the medicine must be no more than 1 microgram/kg or 1 microgram/L or 0.0000001%.

 

4188

PRUNUS PERSICA

A, E, H

Amygdalin and hydrocyanic acid are mandatory components of Prunus persica.

The concentration of Amygdalin in the medicine must be 0%.

The concentration of Hydrocyanic acid in the medicine must be no more than 1 microgram/kg or 1 microgram/L or 0.0000001%.

 

4189

PRUNUS SALICINA

A, E, H

Amygdalin and hydrocyanic acid are mandatory components of Prunus salicina.

The concentration of Amygdalin in the medicine must be 0%.

The concentration of Hydrocyanic acid in the medicine must be no more than 1 microgram/kg or 1 microgram/L or 0.0000001%.

 

4190

PRUNUS SEROTINA

A, E, H

Amygdalin and hydrocyanic acid are mandatory components of Prunus serotina.

The concentration of Amygdalin in the medicine must be 0%.

The concentration of Hydrocyanic acid in the medicine must be no more than 1 microgram/kg or 1 microgram/L or 0.0000001%.

 

4191

PRUNUS SPINOSA

A, E, H

Amygdalin and hydrocyanic acid are mandatory components of Prunus spinosa.

The concentration of Amygdalin in the medicine must be 0%.

The concentration of Hydrocyanic acid in the medicine must be no more than 1 microgram/kg or 1 microgram/L or 0.0000001%.

 

4192

PRUSSIAN BLUE

E

Permitted for use only as a colour for topical use.

 

4193

PSEUDOCYDONIA SINENSIS

A, H

 

4194

PSEUDOSTELLARIA HETEROPHYLLA

A, E, H

 

4195

PSEUDOTSUGA MENZIESII

A, H

 

4196

PSEUDOWINTERA COLORATA

A, H

Only for use when the plant part is leaf.

 

4197

PSIDIUM GUAJAVA

A, E, H

 

4198

PSORINUM

H

Only for use as an active homoeopathic ingredient. 

 

4199

PSYLLIUM HUSK DRY

A, H

When a dose for children is stated, the following warning statement is required on the label:

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

 

4200

PSYLLIUM HUSK POWDER

A, E, H

When a dose for children is stated, the following warning statement is required on the label:

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

 

4201

PSYLLIUM SEED DRY

A, E, H

When a dose for children is stated the following warning statement is required on the label:

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

 

4202

PTELEA TRIFOLIATA

A, H

 

4203

PTEROCARPUS MARSUPIUM

A, H

 

4204

PTEROCARPUS SANTALINUS

A, E, H

 

4205

PUERARIA LOBATA

A, E, H

 

4206

PUERARIA MONTANA VAR. LOBATA

A, E, H

 

4207

PULLULAN

E

 

4208

PUMICE

E

 

4209

PUMPKIN

E

 

4210

PUMPKIN SEED OIL

E, H

 

4211

PUNICA GRANATUM

A, E, H

 

4212

PURE BEE VENOM

H

Only for use as an active homoeopathic ingredient.

 

4213

PURIFIED HONEY

A, E

When the route of administration is oral, the following warning statement is required on the medicine label:

- (BABY2) 'Not suitable for infants under the age of twelve months' (or words to that effect).

 

4214

PURIFIED SILICEOUS EARTH

E, H

 

4215

PURIFIED TALC

E

 

4216

PURIFIED WATER

E

 

4217

PVM/MA COPOLYMER

E

 

4218

PVM/MA DECADIENE CROSSPOLYMER

E

Only for use in topical medicines for dermal application.

 

4219

PVP/EICOSENE COPOLYMER

E

Only for use in topical medicines for dermal application.

 

4220

PVP/HEXADECENE COPOLYMER

E

Only for use in topical medicines for dermal application.

 

4221

PYRETHRINS

E

Only for use in topical medicines for dermal application.

The concentration in the medicine must be no more than 10%.

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

- (PYRTH3) 'Contains pyrethrins [insert quantity]' (or words to that effect).

 

4222

PYRIDOXAL 5-PHOSPHATE

A, E

Pyridoxine is a mandatory component of pyridoxal 5-phosphate.

The percentage of pyridoxine from pyridoxal 5-phosphate should be calculated based on the molecular weight of pyridoxal 5-phosphate.

The maximum recommended daily dose of the medicine must not provide more than:

(i) 15 mg of pyridoxine for children aged between 1 and 3 years (inclusive);

(ii) 20 mg of pyridoxine for children aged between 4 and 8 years (inclusive);

(iii) 30 mg of pyridoxine for children aged between 9 and 13 years (inclusive);

(iv) 40 mg of pyridoxine for individuals aged 14 and 18 years (inclusive); and

(v) 100 mg of pyridoxine for individuals aged 19 years and older.

If the maximum recommended daily dose of the medicine provides more than 10 mg of pyridoxine, the following warning statement is required on the medicine label:

- (VITB6SX) 'WARNING - Stop taking this medication if you experience tingling, burning or numbness and see your healthcare practitioner as soon as possible. [Contains vitamin B6].

 

4223

PYRIDOXAL 5-PHOSPHATE MONOHYDRATE

A

Pyridoxine is a mandatory component of pyridoxal 5-phosphate monohydrate.

The percentage of pyridoxine from pyridoxal 5-phosphate monohydrate should be calculated based on the molecular weight of pyridoxal 5-phosphate monohydrate.

The maximum recommended daily dose of the medicine must not provide more than:

(i) 15 mg of pyridoxine for children aged between 1 and 3 years (inclusive);

(ii) 20 mg of pyridoxine for children aged between 4 and 8 years (inclusive);

(iii) 30 mg of pyridoxine for children aged between 9 and 13 years (inclusive);

(iv) 40 mg of pyridoxine for individuals aged 14 and 18 years (inclusive); and

(v) 100 mg of pyridoxine for individuals aged 19 years and older.

If the maximum recommended daily dose of the medicine provides more than 10 mg of pyridoxine, the following warning statement is required on the medicine label:

- (VITB6SX) 'WARNING - Stop taking this medication if you experience tingling, burning or numbness and see your healthcare practitioner as soon as possible. [Contains vitamin B6].'

 

4224

PYRIDOXINE HYDROCHLORIDE

A, E, H

When not used as an active homoeopathic ingredient, pyridoxine is a mandatory component of pyridoxine hydrochloride.

The percentage of pyridoxine from pyridoxine hydrochloride should be calculated based on the molecular weight of pyridoxine hydrochloride.

The maximum recommended daily dose of the medicine must not provide more than:

(i) 15 mg of pyridoxine for children aged between 1 and 3 years (inclusive);

(ii) 20 mg of pyridoxine for children aged between 4 and 8 years (inclusive);

(iii) 30 mg of pyridoxine for children aged between 9 and 13 years (inclusive);

(iv) 40 mg of pyridoxine for individuals aged 14 and 18 years (inclusive); and

(v) 100 mg of pyridoxine for individuals aged 19 years and older.

If the maximum recommended daily dose of the medicine provides more than 10 mg of pyridoxine, the following warning statement is required on the medicine label:

- (VITB6SX) 'WARNING - Stop taking this medication if you experience tingling, burning or numbness and see your healthcare practitioner as soon as possible. [Contains vitamin B6].'

 

4225

PYROGLUTAMIC ACID

E

 

4226

PYROLA DECORATA

A, H

 

4227

PYROLIGNEOUS 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%.

 

4228

PYRROSIA LINGUA

A, H

 

4229

PYRROSIA PETIOLOSA

A, H

 

4230

PYRROSIA SHEARERI

A, H

 

4231

PYRUS COMMUNIS

A, E, H

Beta-arbutin is a mandatory component of Pyrus communis.

When for oral use, the maximum recommended daily dose must not provide more than 500 mg of beta-arbutin.

When for dermal application exclusively to the face:

a) the concentration of beta-arbutin in the medicine must not be more than 7%; 

b) hydroquinone is a mandatory component; and

c) the concentration of hydroquinone must not be more than 10 mg/kg or 10 mg/L or 0.001%.

When for use other than oral or dermal application exclusively to the face, the concentration of beta-arbutin in the medicine must not be more than 10 mg/kg or 10 mg/L or 0.001%.

 

4232

PYRUS PYRIFOLIA

A, H

Beta-arbutin is a mandatory component of Pyrus pyrifolia.

When for oral use, the maximum recommended daily dose must not provide more than 500 mg of beta-arbutin.

When for dermal application exclusively to the face:

a) the concentration of beta-arbutin in the medicine must not be more than 7%;

b) hydroquinone is a mandatory component; and

c) the concentration of hydroquinone must not be more than 10 mg/kg or 10 mg/L or 0.001%.

When for use other than oral or dermal application exclusively to the face, the concentration of beta-arbutin in the medicine must not be more than 10 mg/kg or 10 mg/L or 0.001%.

 

4233

PYRUVIC 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%.

 

4234

QUASSIA

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%.

 

4235

QUASSIA AMARA

A, E, H

 

4236

QUASSIA WOOD JAMAICAN DRY

A, H

 

4237

QUASSIA WOOD JAMAICAN POWDER

A, H

 

4238

QUATERNIUM-15

E

Only for use in topical medicines for dermal application.

 

4239

QUATERNIUM-18 BENTONITE

E

Only for use in topical medicines for dermal application.

 

4240

QUATERNIUM-18 HECTORITE

E

Only for use in topical medicines for dermal application.

 

4241

QUATERNIUM-52

E

Only for use in wash-on/wash-off topical medicines for dermal 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%.

Not be used in medicines in which N-nitroso compounds may be formed.

 

4242

QUATERNIUM-80

E

Only for use in topical medicines for dermal 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%.

 

4243

QUERCETIN

A

 

4244

QUERCETIN DIHYDRATE

A

 

4245

QUERCUS ACUTISSIMA

A, H

 

4246

QUERCUS ALBA

A, E, H

 

4247

QUERCUS PALUSTRIS

A, H

 

4248

QUERCUS ROBUR

A, H

 

4249

QUERCUS RUBRA

A, H

 

4250

QUERCUS VIRGINIANA

A, H

 

4251

QUILLAIA DRY

A, H

 

4252

QUILLAIA POWDER

A, E, H

 

4253

QUILLAJA SAPONARIA

A, H

 

4254

QUINCE

E

 

4255

QUININE ARSENITE

H

Only for use as an active homoeopathic ingredient.

Quinine is a mandatory component of Quinine arsenite.

The maximum recommended daily dose must be no more than 50 mg of quinine.

 

4256

QUININE SULFATE DIHYDRATE

H

Only for use as an active homoeopathic ingredient. 

Quinine is a mandatory component of quinine sulfate dihydrate. 

The maximum recommended daily dose must be no more than 50 mg of quinine.

 

4257

QUINOLINE YELLOW

E

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

 

4258

QUINOLINE YELLOW ALUMINIUM LAKE

E

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

 

4259

QUISQUALIS INDICA

A, H

 

4260

R-ALPHA LIPOIC ACID

A

 

4261

RACEMENTHOL

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%.

 

4262

RACEMIC CAMPHOR

E, H

Only for use as an active homoeopathic or excipient ingredient.

In solid and semi solid preparations, the concentration of camphor must be no more than 12.5%.

In liquid preparations other than essential oils, the concentration of camphor must be no more than 2.5%.

In essential oil preparations, if the concentration of camphor is more than 2.5% but less than or equal to 10%, and the nominal capacity of the container is less than 25 millilitres, the medicine must have a restricted flow insert fitted on the container and include the following warning statements on the medicine label:

- (CHILD) 'Keep out of reach of children' (or words to that effect); and

- (NTAKEN) 'Not to be taken'.

In essential oil preparations, if the concentration of camphor is more than 10%, and the nominal capacity of the container is less than 15 millilitres, the medicine must have a restricted flow insert fitted on the container and include the following warning statements on the medicine label:

- (CHILD) 'Keep out of reach of children' (or words to that effect); and

- (NTAKEN) 'Not to be taken'.

In essential oil preparations, if the concentration of camphor is more than 10%, and the nominal capacity of the container is more than 15 millilitres but less than or equal to 25 millilitres, the medicine must have a restricted flow insert and child resistant closure fitted on the container and include the following warning statements on the medicine label:

- (CHILD) 'Keep out of reach of children' (or words to that effect); and

- (NTAKEN) 'Not to be taken'.

If the concentration of camphor is more than 2.5%, the nominal capacity of the container must be no more than 25 millilitres.

 

4263

RADISH

E

 

4264

RAISIN JUICE CONCENTRATE

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%.

 

4265

RANUNCULUS BULBOSUS

A, H

 

4266

RANUNCULUS FICARIA

A, H

 

4267

RANUNCULUS TERNATUS

A, H

 

4268

RAPE SEED OIL

A, E, H

Allyl isothiocyanate is a mandatory component of rape seed oil when the plant part is seed.

The concentration of allyl isothiocyanate from all ingredients in the product must be no more than 10 mg/kg or 10 mg/L or 0.001%.

 

4269

RAPHANUS SATIVUS

A, H

 

4270

RASPBERRY

E

 

4271

RASPBERRY BRANDY

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%.

 

4272

RASPBERRY DISTILLATE

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%.

 

4273

RASPBERRY FRUIT EXTRACT

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%.

 

4274

RASPBERRY JUICE CONCENTRATE

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%.

 

4275

RAUWOLFIA SERPENTINA

A, H

The concentration of equivalent dry Rauwolfia serpentina in the medicine must be no more than 10mg/Kg or 10mg/L or 0.001%.

 

4276

RAUWOLFIA SERPENTINA DRY

A, H

The concentration of Rauwolfia Serpentina Dry in the medicine must be no more than 10mg/Kg or 10mg/L or 0.001%.

 

4277

RAUWOLFIA SERPENTINA POWDER

A, H

The concentration of Rauwolfia Serpentina Powder in the medicine must be no more than 10mg/Kg or 10mg/L or 0.001%.

 

4278

RED 27

E

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

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

 

4279

RED 27 ALUMINIUM LAKE

E

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

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

 

4280

RED ANT

H

Only for use as an active homoeopathic ingredient.

 

4281

RED CLOVER FLOWER DRY

A, H

 

4282

RED CLOVER FLOWER POWDER

A, H