3583

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%.

3584

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%.

3585

PADIMATE O

A

Only for use as an active ingredient in sunscreens. 

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

The concentration in the medicine must be no more than 8%.

3586

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%.

3587

PAEONIA LACTIFLORA

A,E,H

3588

PAEONIA OBOVATA

A,H

3589

PAEONIA SUFFRUTICOSA

A,E,H

3590

PAEONIA VEITCHII

A,H

3591

PALIURUS SPINA-CHRISTI

A,H

3592

PALLADIUM

H

Only for use as an active homoeopathic ingredient.

3593

PALM FRUIT OIL

A,E,H

3594

PALM GLYCERIDES

E

3595

PALM KERNEL OIL

A,E,H

3596

PALM TOCOTRIENOLS COMPLEX

A,H

3597

PALMAROSA OIL

A,E,H

3598

PALMITIC ACID

E

3599

PALMITOLEIC ACID-RICH FATTY ACID ETHYL ESTERS

A

3600

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%.

3601

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%

3602

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%.

3603

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%.

3604

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%.

3605

PANAX GINSENG

A,E,H

3606

PANAX JAPONICUS

A,H

3607

PANAX NOTOGINSENG

A,H

3608

PANAX PSEUDOGINSENG

A,H

3609

PANAX QUINQUEFOLIUS

A,H

3610

PANICUM MILIACEUM

A,H

3611

PANTETHINE

E

Only for use in topical medicines for dermal application.

3612

PANTHENOL

A,E

When used as an active ingredient and the route of administration is oral or sublingual, the medicine requires the following warning statement on the medicine label:

- (VIT) ‘Vitamins can only be of assistance if the dietary vitamin intake is inadequate.’ or ‘Vitamin supplements should not replace a balanced diet.’

3613

PANTHENYL ETHYL ETHER

E

Only for use in topical medicines for dermal application.

3614

PANTOLACTONE

E

3615

PANTOTHENIC ACID

A,E

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

3616

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%.

3617

PAPAIN

A,E

3618

PAPER

E

Only for use in topical medicines for dermal application.

3619

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%.

3620

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%.

3621

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%.

3622

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%.

3623

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%.

3624

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%.

3625

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%.

3626

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%.

3627

PARA-HYDROXYBENZOIC ACID

E

3628

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%.

3629

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%.

3630

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%.

3631

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%.

3632

PARA-PROPYL ANISOLE

E

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

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

3633

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%.

3634

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%.

3635

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%.

3636

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%.

3637

PARAMERIA LAEVIGATA

A,H

3638

PARIETARIA JUDAICA

A,H

3639

PARIS POLYPHYLLA

A,H

3640

PARIS QUADRIFOLIA

A,H

3641

PARSLEY

E,H

3642

PARSLEY HERB DRY

A,E,H

3643

PARSLEY HERB OIL

A,E,H

3644

PARSLEY HERB POWDER

A,E,H

3645

PARSLEY SEED OIL

A,E,H

3646

PARTHENOCISSUS TRICUSPIDATA

A,H

3647

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%.

3648

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%.

3649

PASPALUM NOTATUM

A,H

3650

PASSIFLORA CAERULEA

A,H

3651

PASSIFLORA EDULIS

E

3652

PASSIFLORA HERB DRY

A,H

3653

PASSIFLORA INCARNATA

A,E,H

3654

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%.

3655

PATENT BLUE V

E

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

3656

PATENT BLUE V ALUMINIUM LAKE

E

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

3657

PATRINIA SCABIOSIFOLIA

A,H

3658

PATRINIA VILLOSA

A,H

3659

PAULLINIA CUPANA

A,E,H

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

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

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

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

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

3660

PAULLINIA PINNATA

A,H

3661

PAWPAW

E

3662

PEA

E

3663

PEA STARCH

E

3664

PEACH

E

3665

PEANUT

E

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

- (PEANUT) 'Contains [insert ingredient name]'.

3666

PEAR

E

3667

PECAN

E

3668

PECTIN

A,E

3669

PEG-10 SOYA STEROL

E

Only for use in topical medicines for dermal application.

3670

PEG-100 STEARATE

E

Only for use in topical medicines for dermal application.

3671

PEG-12 DILAURATE

E

3672

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%.

3673

PEG-120 METHYL GLUCOSE DIOLEATE

E

Only for use in topical medicines for dermal application.

3674

PEG-120 STEARATE

E

Only for use in topical medicines for dermal application.

3675

PEG-15 COCAMINE

E

Only for use in topical medicines for dermal application.

3676

PEG-150 DISTEARATE

E

Only for use in topical medicines for dermal application.

3677

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%.

3678

PEG-20 METHYL GLUCOSE DISTEARATE

E

Only for use in topical medicines for dermal application.

3679

PEG-20 METHYL GLUCOSE SESQUISTEARATE

E

Only for use in topical medicines for dermal application.

3680

PEG-20 SORBITAN ISOSTEARATE

E

Only for use in topical medicines for dermal application.

3681

PEG-20 STEARATE

E

Only for use in topical medicines for dermal application.

3682

PEG-25 PABA

A

Only for use as an active ingredient in topical sunscreens for dermal application. The concentration in the medicine must be no more than 10%.

3683

PEG-30 DIPOLYHYDROXYSTEARATE

E

Only for use in topical medicines for dermal application.

3684

PEG-30 STEARATE

E

Only for use in topical medicines for dermal application.

3685

PEG-35 CASTOR OIL

E

3686

PEG-4 DILAURATE

E

Only for use in topical medicines for dermal application.

3687

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%.

3688

PEG-4 STEARATE

E

Only for use in topical medicines for dermal application.

3689

PEG-40 CASTOR OIL

E

3690

PEG-40 HYDROGENATED CASTOR OIL

E

3691

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%.

3692

PEG-40 STEARATE

E

Only for use in topical medicines for dermal application.

3693

PEG-45/DODECYL GLYCOL COPOLYMER

E

Only for use in topical medicines for dermal application.

3694

PEG-5 GLYCERYL STEARATE

E

Only for use in topical medicines for dermal application.

3695

PEG-50 STEARATE

E

Only for use in topical medicines for dermal application.

3696

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%.

3697

PEG-6 LAURAMIDE

E

Only for use in topical medicines for dermal application.

3698

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%.

3699

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%.

3700

PEG-60 HYDROGENATED CASTOR OIL

E

Only for use in topical medicines for dermal application.

3701

PEG-7 COCAMIDE

E

Only for use in topical medicines for dermal application.

3702

PEG-7 GLYCERYL COCOATE

E

Only for use in topical medicines for dermal application.

3703

PEG-7 HYDROGENATED CASTOR OIL

E

Only for use in topical medicines for dermal application.

3704

PEG-75 LANOLIN

E

Only for use in topical medicines for dermal application.

3705

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%.

3706

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%.

3707

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%.

3708

PEG-8 DISTEARATE

E

Only for use in topical medicines for dermal application.

3709

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.

3710

PEG-8 PROPYLENE GLYCOL COCOATE

E

3711

PEG-8 STEARATE

E

Only for use in topical medicines for dermal application.

3712

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%.

3713

PELARGONIUM GRAVEOLENS

A,E,H

3714

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%.

3715

PELTIGERA CANINA

A,H

3716

PENICILLIUM EXPANSUM

A,H

3717

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.

3718

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%

3719

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%.

3720

PENTAERYTHRITYL TETRALAURATE

E

Only for use in topical medicines for dermal application.

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

3721

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%.

3722

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%.

3723

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%.

3724

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%.

3725

PEPPER BLACK

E,H

3726

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%.

3727

PEPPER WHITE

E,H

3728

PEPPERMINT AMERICAN EXT.

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%.

3729

PEPPERMINT LEAF DRY

A,E,H

3730

PEPPERMINT LEAF POWDER

A,E,H

3731

PEPPERMINT OIL

A,E,H

3732

PEPPERMINT 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%.

3733

PEPPERMINT TERPENES

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%.

3734

PERFLUOROPOLYMETHYLISOPROPYL ETHER

E

Only for use in topical medicines for dermal application.

3735

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%.

3736

PERILLA FRUTESCENS

A,E,H

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

3737

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%.

3738

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%.

3739

PERMETHRIN

E

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

3740

PERSEA AMERICANA

A,E,H

3741

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%.

3742

PERSICARIA CHINENSIS

A,H

3743

PERSICARIA TINCTORIA

A,H

3744

PERSIMMON

E

3745

PERU BALSAM

A,E,H

3746

PERU BALSAM OIL

A,E,H

3747

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%

3748

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%.

3749

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.

3750

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%.

3751

PETROSELINUM CRISPUM

A,E,H

3752

PEUCEDANUM PRAERUPTORUM

A,E,H

3753

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).

3754

PHALARIS ARUNDINACEA

A,H

3755

PHALARIS CANARIENSIS

A,H

3756

PHASEOLUS COCCINEUS

A,H

3757

PHASEOLUS VULGARIS

A,H

3758

PHELLINUS ROBINIAE

A,E,H

3759

PHELLODENDRON AMURENSE

A,E,H

3760

PHELLODENDRON CHINENSE

A,H

3761

PHENACETIN

E

Only for use in topical medicines for dermal application.

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

3762

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%.

3763

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%.

3764

PHENETHYL ALCOHOL

E

Only for use in topical medicines for dermal application.

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

- (PHEALC) 'Contains phenethyl alcohol' (or words to that effect).

3765

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%.

3766

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%

3767

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%.

3768

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%.

3769

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%.

3770

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%.

3771

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%.

3772

PHENOL

E

Only for use in topical medicines for dermal application.

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

- (PHENOL) 'Contains phenol' (or words to that effect).

The concentration of phenols in the medicine including cresols and xylenols and any other homologue of phenol boiling below 220 degrees centigrade must be no more than 3%.

3773

PHENOXYETHANOL

E

Only for use in topical medicines for dermal application.

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

- (PHOETH) 'Contains phenoxyethanol' (or words to that effect).

3774

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%.

3775

PHENOXYETHYLPARABEN

E

Only for use in topical medicines for dermal application.

3776

PHENYL DIMETHICONE

E

Only for use in topical medicines for dermal application.

3777

PHENYL TRIMETHICONE

E

Only for use in topical medicines for dermal application.

3778

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%.

3779

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%.

3780

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%.

3781

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%.

3782

PHENYLALANINE

A,E

When for oral ingestion the medicine requires the following warning statement on the medicine label:

- (PKU) 'Phenylketonurics are warned that this medicine contains phenylalanine' (or words to that effect).

When the medicine contains more than 500mg in the maximum recommended daily dose it requires the following warning statement on the medicine label:

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

3783

PHENYLBENZIMIDAZOLE SULFONIC ACID

A

Only for use as an active ingredient in sunscreens.

Only for use in topical medicines for dermal 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%.

3784

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%.

3785

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%.

3786

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%.

3787

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%.

3788

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%.

3789

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%.

3790

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%.

3791

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%.

3792

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%.

3793

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%.

3794

PHLEUM PRATENSE

A,H

3795

PHLOXINE B

E

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

3796

PHLOXINE B ALUMINIUM LAKE

E

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

3797

PHOENIX DACTYLIFERA

A,E,H

3798

PHOSPHATIDYL CHOLINE

E

3799

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%.

3800

PHOSPHORIC ACID

E,H

Only for use as an active homoeopathic ingredient. 

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

3801

PHOSPHORUS

H

Only for use as an active homoeopathic ingredient. 

3802

PHOTINIA SERRULATA

A,H

3803

PHRAGMITES AUSTRALIS

A,H

3804

PHYLA DULCIS

A,H

3805

PHYLLANTHUS AMARUS

A,H

3806

PHYLLANTHUS EMBLICA

A,E,H

Only for use in topical medicines for dermal application.

When ascorbic acid is claimed as a component the plant part is restricted to fruit.

3807

PHYLLOSTACHYS NIGRA

A,E,H

3808

PHYSALIS ALKEKENGI

A,H

3809

PHYSALIS PUBESCENS

A,H

3810

PHYTANTRIOL

E

Only for use in topical medicines for dermal application.

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

3811

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%.

3812

PHYTOLACCA AMERICANA

A,H

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

3813

PHYTOMENADIONE

A,E

When used as an active ingredient and the route of administration is oral or sublingual, the medicine requires the following warning statement on the medicine label:

- (VIT) ‘Vitamins can only be of assistance if the dietary vitamin intake is inadequate.’ or ‘Vitamin supplements should not replace a balanced diet.’

3814

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%.

3815

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%.

3816

PICEA ABIES

A,H

3817

PICEA MARIANA

A,H

3818

PICRASMA EXCELSA

A,E,H

3819

PICRORRHIZA KURROA

A,E,H

3820

PIGMENT BLUE 15

E

Permitted for use as a colour for topical and dental use.

The concentration in medicine must be no more than 0.003%.

3821

PIGMENT BLUE 15:1

E

Permitted for use 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%.

3822

PIGMENT GREEN 7

E

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%.

Permitted for use as a colour for topical and dental use.

3823

PIGMENT RED 4

E

Permitted for use as a colour for topical use.

3824

PIGMENT RED 53

E

Permitted for use as a colour for topical use.

3825

PIGMENT RED 57

E

Permitted for use as a colour for topical use.

3826

PIGMENT RED 57 ALUMINIUM LAKE

E

Permitted for use as a colour for topical use.

3827

PIGMENT RED 63

E

Permitted for use as a colour for topical use.

3828

PIGMENT WHITE 26

E

Permitted for use as a colour for topical use.

3829

PIGMENT YELLOW 12

E

Permitted for use as a colour for topical use.

3830

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%.

3831

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%.

3832

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%.

3833

PIMENTA FRUIT OIL

A,E,H

3834

PIMENTA LEAF OIL

A,E,H

3835

PIMENTA OFFICINALIS

A,E,H

3836

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'.

3837

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).

3838

PIMPINELLA SAXIFRAGA

A,E,H

3839

PINE NEEDLE OIL SCOTCH

A,E,H

3840

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%.

3841

PINE OIL AROMATIC

A,E,H

3842

PINE OIL PUMILIO

A,E,H

3843

PINEAPPLE

E

3844

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%.

3845

PINELLIA TERNATA

A,H

3846

PINUS CONTORTA

A,E,H

3847

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%.

3848

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%.

3849

PINUS MONTICOLA

A,E,H

3850

PINUS MUGO

A,E,H

3851

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%.

3852

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%.

3853

PINUS PONDEROSA

A,E,H

3854

PINUS RADIATA

A,E,H

3855

PINUS STROBUS

A,E,H

3856

PINUS SYLVESTRIS

A,E,H

3857

PINUS TABULIFORMIS

A,E,H

3858

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%.

3859

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%.

3860

PIPER CHABA

A,E,H

3861

PIPER CUBEBA

A,E,H

3862

PIPER EXCELSUM VAR. MAJOR

A,H

3863

PIPER KADSURA

A,E,H

3864

PIPER LONGUM

A,E,H

3865

PIPER METHYSTICUM

A,H

Kavalactones (of Piper methysticum) is a mandatory component of Piper methysticum.

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 plant preparation must be an aqueous dispersion or aqueous extract of dried 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.

3866

PIPER NIGRUM

A,E,H

3867

PIPER SARMENTOSUM

A,E,H

3868

PIPERIDINE

E

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

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

3869

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%.

3870

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%.

3871

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%.

3872

PIPERONYL BUTOXIDE

E

Only for use in topical medicines for dermal application.

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

- (PIPBUT) 'Contains piperonyl butoxide' (or words to that effect).

3873

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.

3874

PISCIDIA PISCIPULA

A,E,H

3875

PISTACIA LENTISCUS

A,E,H

3876

PISUM SATIVUM

A,E,H

3877

PLACENTA

H

Only for use as an active homoeopathic ingredient.

3878

PLANTAGO AFRA

A,E,H

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

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

3879

PLANTAGO ARENARIA

A,H

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

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

3880

PLANTAGO ASIATICA

A,H

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

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

3881

PLANTAGO LANCEOLATA

A,E,H

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

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

3882

PLANTAGO MAJOR

A,E,H

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

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

3883

PLANTAGO OVATA

A,H

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

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

3884

PLANTAGO SEED DRY

A,H

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

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

3885

PLATANUS OCCIDENTALIS

A,E,H

3886

PLATANUS RACEMOSA

A,H

3887

PLATANUS X ACERIFOLIA

A,H

3888

PLATYCODON GRANDIFLORUS

A,E,H

3889

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%.

3890

PLUM

E

3891

PLUMBAGO EUROPAEA

A,H

3892

PLUMERIA ALBA

A,E,H

3893

PLUMERIA RUBRA

A,E,H

3894

POA NEMORALIS

A,H

3895

POA PRATENSIS

A,H

3896

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%.

3897

POGOSTEMON CABLIN

A,E,H

3898

POLACRILIN

E

3899

POLACRILIN POTASSIUM

E

3900

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).

3901

POLIGLUSAM

A,E

When used orally, the medicine requires the following warning statements on the medicine label:

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

 (for powdered dosage forms only) 'Do not take powder alone. Mix with food or fluid.'

- (SFOOD) 'Derived from seafood'.

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

3902

POLIGLUSAM DERIVED FROM ASPERGILLUS NIGER

A,E

When for oral use, the medicine must provide no more than 2000 milligrams of Poliglusam derived from Aspergillus niger per maximum recommended daily dose and requires the following warning statement on the medicine label:

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

If the medicine is a powdered dosage form, the medicine also requires the following warning statement on the medicine label:

‑ 'Do not take powder alone. Mix with food or fluid.'

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

3903

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.

Divided preparations for internal use must contain more than 33 micrograms of Retinol Equivalents per dosage unit and no more than 3000 micrograms of Retinol Equivalents of Vitamin A in the maximum daily dose.

Undivided preparations for internal use must contain more than 33 micrograms Retinol Equivalents per gram of vitamin A and no more than 3000 micrograms of Retinol Equivalents of Vitamin A in the maximum daily dose.

When for use in adults 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.

When used as an active ingredient and the route of administration is oral or sublingual, the medicine requires the following warning statement on the medicine label:

- (VIT) ‘Vitamins can only be of assistance if the dietary vitamin intake is inadequate.’ or ‘Vitamin supplements should not replace a balanced diet.’

The indication 'Vitamin D helps calcium absorption (or words of like intent) and a diet deficient in calcium can lead to osteoporosis in later life' is permitted only for oral use.

3904

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).

3905

POLOXAMER

E

Only for use in topical medicines for dermal application.

3906

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%.

3907

POLOXAMINE 1301

E

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

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

3908

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%.

3909

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%.

3910

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%.

3911

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%.

3912

POLYACRYLIC ACID

E

3913

POLYAMINO SUGAR CONDENSATE

E

Only for use in topical medicines for dermal application.

3914

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%.

3915

POLYBUTENE

E

Only for use in topical medicines for dermal application.

3916

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%.

3917

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%.

3918

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%.

3919

POLYDEXTROSE

E

3920

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%.

3921

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%

3922

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%.

3923

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%.

3924

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%.

3925

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%.

3926

POLYETHYLENE

E

3927

POLYGALA CHINENSIS

A,H

3928

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.

3929

POLYGALA SIBIRICA

A,E,H

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

3930

POLYGALA TENUIFOLIA

A

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

3931

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%.

3932

POLYGLYCERYL-2-PEG-4 STEARATE

E

Only for use in topical medicines for dermal application.

3933

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%.

3934

POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE

E

Only for use in topical medicines for dermal application. 

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

3935

POLYGLYCERYL-2 TRIISOSTEARATE

E

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

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

3936

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%.

3937

POLYGLYCERYL-3 DIISOSTEARATE

E

Only for use in topical medicines for dermal application.

3938

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%.

3939

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%.

3940

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%.

3941

POLYGLYCERYL-3 POLYRICINOLEATE

E

3942

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%.

3943

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%.

3944

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%.

3945

POLYGLYCERYL-4 OLEATE

E

Only for use in topical medicines for dermal application.

3946

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%.

3947

POLYGLYCERYL-6 RICINOLEATE

E

Only for use in topical medicines for dermal application.

3948

POLYGONATUM MULTIFLORUM

A,H

3949

POLYGONATUM OFFICINALE

A,H

3950

POLYGONATUM SIBIRICUM

A,E,H

3951

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%.

3952

POLYGONUM BISTORTA

A,H

3953

POLYGONUM CUSPIDATUM

A,E,H

3954

POLYGONUM ODORATUM

A,H

3955

POLYHYDROXYSTEARIC ACID

E

Only for use in topical medicines for dermal application.

3956

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.

3957

POLYISOPRENE

E

Only for use in topical medicines for dermal application.

3958

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%.

3959

POLYMETHACRYLIC ACID

E

3960

POLYMETHYL METHACRYLATE

E

Only for use in topical medicines for dermal application.

3961

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%.

3962

POLYPORUS UMBELLATUS

A,H

3963

POLYPROPYLENE

E

Only for use in topical medicines for dermal application.

3964

POLYQUATERNIUM-10

E

Only for use in topical medicines for dermal application.

3965

POLYQUATERNIUM-11

E

Only for use in topical medicines for dermal application.

3966

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%.

3967

POLYQUATERNIUM-24

E

Only for use in topical medicines for dermal application.

3968

POLYQUATERNIUM-28

E

Only for use in topical medicines for dermal application.

3969

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%.

3970

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%.

3971

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%.

3972

POLYQUATERNIUM-7

E

Only for use in topical medicines for dermal application.

3973

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%

3974

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%.

3975

POLYSILICONE-15

A

Only for use as an active ingredient in sunscreens.

Only for use in topical medicines for dermal application.

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

3976

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%.

3977

POLYSORBATE 20

E

3978

POLYSORBATE 40

E

3979

POLYSORBATE 60

E

3980

POLYSORBATE 65

E

3981

POLYSORBATE 80

E

3982

POLYSORBATE 85

E

Only for use in topical medicines for dermal application.

3983

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%.

3984

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.

3985

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%.

3986

POLYVINYL ACETATE

E

Only for use when the dosage form is chewing gum.

3987

POLYVINYL ACETATE PHTHALATE

E

3988

POLYVINYL ALCOHOL

E

3989

POLYVINYL CHLORIDE

E

Only for use in topical medicines for dermal application.

3990

POMEGRANATE

E

3991

PONCEAU SX

E

Permitted for use as a colour for topical use.

3992

PONCIRUS TRIFOLIATA

A,H

When used interally, 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.

3993

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%.

3994

POPPY SEED

E,H

3995

POPPY SEED OIL

E,H

3996

POPULUS ALBA

A,H

3997

POPULUS BALSAMIIFERA

A,E,H

3998

POPULUS CANDICANS

A,H

3999

POPULUS DELTOIDES

A,H

4000

POPULUS NIGRA

A,H

4001

POPULUS TREMULA

A,H

4002

POPULUS TREMULOIDES

A,H

4003

PORCINE

H

Only for use as an active homoeopathic ingredient. 

4004

PORIA COCOS

A,E,H

4005

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%.

4006

PORTULACA OLERACEA

A,E,H

4007

POTABLE WATER

E

4008

POTASSIUM ACETATE

E

4009

POTASSIUM ARSENITE

H

Only for use as an active homoeopathic ingredient.

4010

POTASSIUM ASCORBATE

A,E,H

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

When used as an active ingredient and the route of administration is oral or sublingual, the medicine requires the following warning statement on the medicine label:

- (VIT) ‘Vitamins can only be of assistance if the dietary vitamin intake is inadequate.’ or ‘Vitamin supplements should not replace a balanced diet.’

4011

POTASSIUM ASCORBATE DIHYDRATE

A,E,H

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

When used as an active ingredient and the route of administration is oral or sublingual, the medicine requires the following warning statement on the medicine label:

- (VIT) ‘Vitamins can only be of assistance if the dietary vitamin intake is inadequate.’ or ‘Vitamin supplements should not replace a balanced diet.’

4012

POTASSIUM ASCORBYL TOCOPHERYL PHOSPHATE

E

Only for use in topical medicines for dermal application.

4013

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. The percentage of Potassium from Potassium aspartate should be calculated based on the molecular weight of Potassium aspartate.

The indication ‘For mineral (may state the mineral) supplementation’ is only permitted when the medicine is for oral or sublingual use.

4014

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.

4015

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.

4016

POTASSIUM BICARBONATE

E

4017

POTASSIUM BROMIDE

H

Only for use as an active homoeopathic ingredient. 

4018

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.

The indication ‘For mineral (may state the mineral) supplementation’ is only permitted when the medicine is for oral or sublingual use.

4019

POTASSIUM CETYL PHOSPHATE

E

Only for use in topical medicines for dermal application.

4020

POTASSIUM CHLORIDE

A,E,H

When for oral use:

a) potassium is a mandatory component of potassium chloride;

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

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

c) other than when used for oral rehydration therapy, the concentration must be no more than 550 mg per dosage unit.

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

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

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

c) the medicine requires the warning statements:

- (UOAD) 'Use only as directed'

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

When for dental use, the concentration in the medicine must be no more than 3.75%.

4021

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.

The percentage of potassium from Potassium citrate should be calculated based on the molecular weight of Potassium citrate.

The indication ‘For mineral (may state the mineral) supplementation’ is only permitted when the medicine is for oral or sublingual use.

4022

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%.

4023

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%.

4024

POTASSIUM DICHROMATE

H

Only for use as an active homoeopathic ingredient.

4025

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.

The percentage of potassium from Potassium gluconate should be calculated based on the molecular weight of Potassium gluconate.

The indication ‘For mineral (may state the mineral) supplementation’ is only permitted when the medicine is for oral or sublingual use.

4026

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.

The percentage of Potassium from potassium glycerophosphate should be calculated based on the molecular weight of potassium glycerophosphate.

The indication ‘For mineral (may state the mineral) supplementation’ is only permitted when the medicine is for oral or sublingual use.

4027

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.

4028

POTASSIUM HYDROXYCITRATE

A,H

The indication ‘For mineral (may state the mineral) supplementation’ is only permitted when the medicine is for oral or sublingual use.

4029

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.

4030

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.

Only for internal use when the medicine contains less than 300 micrograms of iodine per maximum recommended daily dose.

Only for external use when the concentration of iodine in the medicine (excluding salts derivatives or iodophors) is 2.5% or less.

If used as an active ingredient and the preparation is intended as a mineral supplementation, potassium is a mandatory component of potassium iodide.

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

The indication ‘For mineral (may state the mineral) supplementation’ is only permitted when the medicine is for oral or sublingual use.

4031

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%.

4032

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%.

4033

POTASSIUM NITRATE

A,H

Only for dental use.

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

4034

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.

The percentage of potassium from Potassium  orotate should be calculated based on the molecular weight 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.

The indication ‘For mineral (may state the mineral) supplementation’ is only permitted when the medicine is for oral or sublingual use.

4035

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%.

4036

POTASSIUM SORBATE

E

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

- (SORB8) 'Contains sorbates' (or word to this effect) if medicine contains two or more sorbate sources OR 'Contains [insert the approved name of sorbate source used]' (or words to this effect) if medicine contains one sorbate source.

4037

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%.

4038

POTASSIUM STEARATE

E

Only for use in topical medicines for dermal application.

4039

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.

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

The indication ‘For mineral (may state the mineral) supplementation’ is only permitted when the medicine is for oral or sublingual use.

4040

POTATO STARCH

E

4041

POTENTILLA ANSERINA

A,H

4042

POTENTILLA CHINENSIS

A,H

4043

POTENTILLA DISCOLOR

A,H

4044

POTENTILLA ERECTA

A,E,H

4045

POTENTILLA REPTANS

A,H

4046

POTERIUM OFFICINALE

A,E,H

4047

POTERIUM SANGUISORBA

A,H

4048

POVIDONE

E

4049

POWDERED CELLULOSE

E

4050

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%.

4051

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%.

4052

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 0.3%.

4053

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%.

4054

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%.

4055

PPG-2 LANOLIN ALCOHOL ETHER

E

Only for use in topical medicines for dermal application.

4056

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%.

4057

PPG-20 LANOLIN ALCOHOL ETHER

E

Only for use in topical medicines for dermal application.

4058

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%.

4059

PPG-20 METHYL GLUCOSE ETHER DISTEARATE

E

Only for use in topical medicines for dermal application.

4060

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%.

4061

PPG-3 MYRISTYL ETHER

E

Only for use in topical medicines for dermal application.

4062

PPG-5-CETETH-20

E

Only for use in topical medicines for dermal application.

4063

PPG-5-LAUROMACROGOL 250

E

Only for use in topical medicines for dermal application.

4064

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%.

4065

PREGELATINISED MAIZE STARCH

E

4066

PREGELATINISED POTATO STARCH

E

4067

PREGELATINISED RICE STARCH

E

4068

PREGELATINISED WHEAT STARCH

E

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

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

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

4069

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%.

4070

PRICKLY ASH BARK DRY

A,H

4071

PRICKLY ASH BARK POWDER

A,H

4072

PRIMULA VERIS

A,E,H

4073

PRIMULA VULGARIS

A,E,H

4074

PRINSEPIA UNIFLORA

A,H

4075

PROGESTERONE

H

Only for use as an active homoeopathic ingredient. 

4076

PROLINE

A,E

4077

PROPAN-1-OL

E

Only for use in topical medicines for dermal application.

The concentration in the medicine must be no more than 18%.

4078

PROPANE

E

Only for use as an excipient propellant ingredient.

4079

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%.

4080

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%.

4081

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%.

4082

PROPIONYLLEVOCARNITINE HYDROCHLORIDE

A,H

4083

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.'

4084

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.'

4085

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.'

4086

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.'

4087

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.'

4088

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.'

4089

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%.

4090

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%.

4091

PROPYL GALLATE

E

4092

PROPYL HYDROXYBENZOATE

E

Medicines containing hydroxybenzoates require the following warning statement on the medicine label:

- (TOTBNZ) ‘Contains hydroxybenzoates’ (or words to this effect) if the medicine contains more than one hydroxybenzoate source OR ‘Contains [insert the approved name of hydroxybenzoate used]’ (or words to this effect) if product contains one hydroxybenzoate source.

4093

PROPYLENE CARBONATE

E

Only for use in topical medicines for dermal application.

4094

PROPYLENE GLYCOL

E

4095

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%.

4096

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%.

4097

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%.

4098

PROPYLENE GLYCOL DIOCTANOATE

E

Only for use in topical medicines for dermal application.

4099

PROPYLENE GLYCOL DIOCTANOATE/DIDECANOATE

E

Only for use in topical medicines for dermal application.

4100

PROPYLENE GLYCOL DIPELARGONATE

E

Only for use in topical medicines for dermal application.

4101

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%.

4102

PROPYLENE GLYCOL ISOSTEARATE

E

Only for use in topical medicines for dermal application.

4103

PROPYLENE GLYCOL MONOLAURATE

E

Only for use in topical medicines for dermal application.

4104

PROPYLENE GLYCOL MONOSTEARATE

E

Only for use in topical medicines for dermal application.