3575

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%.

3576

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%.

3577

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%.

3578

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%.

3579

PAEONIA LACTIFLORA

A, E, H

3580

PAEONIA OBOVATA

A, H

3581

PAEONIA SUFFRUTICOSA

A, E, H

3582

PAEONIA VEITCHII

A, H

3583

PALIURUS SPINA-CHRISTI

A, H

3584

PALLADIUM

H

Only for use as an active homoeopathic ingredient.

3585

PALM FRUIT OIL

A, E, H

3586

PALM GLYCERIDES

E

3587

PALM KERNEL OIL

A, E, H

3588

PALM TOCOTRIENOLS COMPLEX

A, H

3589

PALMARIA PALMATA

A, H

3590

PALMAROSA OIL

A, E, H

3591

PALMITIC ACID

E

3592

PALMITOLEIC ACID-RICH FATTY ACID ETHYL ESTERS

A

3593

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%.

3594

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%

3595

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%.

3596

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%.

3597

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%.

3598

PANAX GINSENG

A, E, H

3599

PANAX JAPONICUS

A, H

3600

PANAX NOTOGINSENG

A, H

3601

PANAX PSEUDOGINSENG

A, H

3602

PANAX QUINQUEFOLIUS

A, H

3603

PANICUM MILIACEUM

A, H

3604

PANTETHINE

E

Only for use in topical medicines for dermal application.

3605

PANTHENOL

A, E

3606

PANTHENYL ETHYL ETHER

E

Only for use in topical medicines for dermal application.

3607

PANTOLACTONE

E

3608

PANTOTHENIC ACID

A, E

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

3609

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%.

3610

PAPAIN

A, E

3611

PAPER

E

Only for use in topical medicines for dermal application.

3612

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%.

3613

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%.

3614

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%.

3615

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%.

3616

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%.

3617

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%.

3618

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%.

3619

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%.

3620

PARA-HYDROXYBENZOIC ACID

E

3621

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%.

3622

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%.

3623

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%.

3624

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%.

3625

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%.

3626

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%.

3627

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%.

3628

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%.

3629

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%.

3630

PARAMERIA LAEVIGATA

A, H

3631

PARIETARIA JUDAICA

A, H

3632

PARIS POLYPHYLLA

A, H

3633

PARIS QUADRIFOLIA

A, H

3634

PARSLEY

E, H

3635

PARSLEY HERB DRY

A, E, H

3636

PARSLEY HERB OIL

A, E, H

3637

PARSLEY HERB POWDER

A, E, H

3638

PARSLEY SEED OIL

A, E, H

3639

PARTHENOCISSUS TRICUSPIDATA

A, H

3640

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%.

3641

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%.

3642

PASPALUM NOTATUM

A, H

3643

PASSIFLORA CAERULEA

A, H

3644

PASSIFLORA EDULIS

E

3645

PASSIFLORA HERB DRY

A, H

3646

PASSIFLORA INCARNATA

A, E, H

3647

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%.

3648

PATENT BLUE V

E

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

3649

PATENT BLUE V ALUMINIUM LAKE

E

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

3650

PATRINIA SCABIOSIFOLIA

A, H

3651

PATRINIA VILLOSA

A, H

3652

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]’.

3653

PAULLINIA PINNATA

A, H

3654

PAWPAW

E

3655

PEA

E

3656

PEA STARCH

E

3657

PEACH

E

3658

PEANUT

E

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

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

3659

PEAR

E

3660

PECAN

E

3661

PECTIN

A, E

3662

PEG-10 SOYA STEROL

E

Only for use in topical medicines for dermal application.

3663

PEG-100 STEARATE

E

Only for use in topical medicines for dermal application.

3664

PEG-12 DILAURATE

E

3665

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%.

3666

PEG-120 METHYL GLUCOSE DIOLEATE

E

Only for use in topical medicines for dermal application.

3667

PEG-120 STEARATE

E

Only for use in topical medicines for dermal application.

3668

PEG-15 COCAMINE

E

Only for use in topical medicines for dermal application.

3669

PEG-150 DISTEARATE

E

Only for use in topical medicines for dermal application.

3670

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%.

3671

PEG-20 METHYL GLUCOSE DISTEARATE

E

Only for use in topical medicines for dermal application.

3672

PEG-20 METHYL GLUCOSE SESQUISTEARATE

E

Only for use in topical medicines for dermal application.

3673

PEG-20 SORBITAN ISOSTEARATE

E

Only for use in topical medicines for dermal application.

3674

PEG-20 STEARATE

E

Only for use in topical medicines for dermal application.

3675

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%.

3676

PEG-30 DIPOLYHYDROXYSTEARATE

E

Only for use in topical medicines for dermal application.

3677

PEG-30 STEARATE

E

Only for use in topical medicines for dermal application.

3678

PEG-35 CASTOR OIL

E

3679

PEG-4 DILAURATE

E

Only for use in topical medicines for dermal application.

3680

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%.

3681

PEG-4 STEARATE

E

Only for use in topical medicines for dermal application.

3682

PEG-40 CASTOR OIL

E

3683

PEG-40 HYDROGENATED CASTOR OIL

E

3684

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%.

3685

PEG-40 STEARATE

E

Only for use in topical medicines for dermal application.

3686

PEG-45/DODECYL GLYCOL COPOLYMER

E

Only for use in topical medicines for dermal application.

3687

PEG-5 GLYCERYL STEARATE

E

Only for use in topical medicines for dermal application.

3688

PEG-50 STEARATE

E

Only for use in topical medicines for dermal application.

3689

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%.

3690

PEG-6 LAURAMIDE

E

Only for use in topical medicines for dermal application.

3691

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%.

3692

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%.

3693

PEG-60 HYDROGENATED CASTOR OIL

E

Only for use in topical medicines for dermal application.

3694

PEG-7 COCAMIDE

E

Only for use in topical medicines for dermal application.

3695

PEG-7 GLYCERYL COCOATE

E

Only for use in topical medicines for dermal application.

3696

PEG-7 HYDROGENATED CASTOR OIL

E

Only for use in topical medicines for dermal application.

3697

PEG-75 LANOLIN

E

Only for use in topical medicines for dermal application.

3698

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%.

3699

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%.

3700

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%.

3701

PEG-8 DISTEARATE

E

Only for use in topical medicines for dermal application.

3702

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.

3703

PEG-8 PROPYLENE GLYCOL COCOATE

E

3704

PEG-8 STEARATE

E

Only for use in topical medicines for dermal application.

3705

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%.

3706

PELARGONIUM GRAVEOLENS

A, E, H

3707

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%.

3708

PELTIGERA CANINA

A, H

3709

PENICILLIUM EXPANSUM

A, H

3710

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.

3711

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%

3712

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%.

3713

PENTAERYTHRITYL TETRALAURATE

E

Only for use in topical medicines for dermal application.

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

3714

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%.

3715

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%.

3716

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%.

3717

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%.

3718

PEPPER BLACK

E, H

3719

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%.

3720

PEPPER WHITE

E, H

3721

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%.

3722

PEPPERMINT LEAF DRY

A, E, H

3723

PEPPERMINT LEAF POWDER

A, E, H

3724

PEPPERMINT OIL

A, E, H

3725

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%.

3726

PEPPERMINT OIL TERPENES AND TERPENOIDS

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%.

3727

PERFLUOROPOLYMETHYLISOPROPYL ETHER

E

Only for use in topical medicines for dermal application.

3728

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%.

3729

PERILLA FRUTESCENS

A, E, H

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

3730

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%.

3731

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%.

3732

PERMETHRIN

E

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

3733

PERSEA AMERICANA

A, E, H

3734

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%.

3735

PERSICARIA CHINENSIS

A, H

3736

PERSICARIA TINCTORIA

A, H

3737

PERSIMMON

E

3738

PERU BALSAM

A, E, H

3739

PERU BALSAM OIL

A, E, H

3740

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%

3741

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%.

3742

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.

3743

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%.

3744

PETROSELINUM CRISPUM

A, E, H

3745

PEUCEDANUM PRAERUPTORUM

A, E, H

3746

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).

3747

PHALARIS ARUNDINACEA

A, H

3748

PHALARIS CANARIENSIS

A, H

3749

PHASEOLUS COCCINEUS

A, H

3750

PHASEOLUS VULGARIS

A, H

3751

PHELLINUS ROBINIAE

A, E, H

3752

PHELLODENDRON AMURENSE

A, E, H

3753

PHELLODENDRON CHINENSE

A, H

3754

PHENACETIN

E

Only for use in topical medicines for dermal application.

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

3755

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%.

3756

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%.

3757

PHENETHYL ALCOHOL

E

Permitted for use only:

(a) in topical medicines for dermal application; and

(b) in oral medicines in combination with other permitted ingredients as part of a flavour proprietary excipient formulation.

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

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

When used in a flavour, the total flavour proprietary excipient formulation in a medicine must be no more than 5%.

3758

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%.

3759

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%

3760

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%.

3761

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%.

3762

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%.

3763

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%.

3764

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%.

3765

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

3766

PHENOXYETHANOL

E

Only for use in topical medicines for dermal application.

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

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

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

3767

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%.

3768

PHENOXYETHYLPARABEN

E

Only for use in topical medicines for dermal application.

3769

PHENYL DIMETHICONE

E

Only for use in topical medicines for dermal application.

3770

PHENYL TRIMETHICONE

E

Only for use in topical medicines for dermal application.

3771

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%.

3772

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%.

3773

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%.

3774

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%.

3775

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'.

3776

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%.

3777

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%.

3778

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%.

3779

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%.

3780

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%.

3781

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%.

3782

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%.

3783

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%.

3784

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%.

3785

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%.

3786

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%.

3787

PHLEUM PRATENSE

A, H

3788

PHLOXINE B

E

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

3789

PHLOXINE B ALUMINIUM LAKE

E

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

3790

PHOENIX DACTYLIFERA

A, E, H

3791

PHOSPHATIDYL CHOLINE

E

3792

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%.

3793

PHOSPHORIC ACID

E, H

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

3794

PHOSPHORUS

H

Only for use as an active homoeopathic ingredient. 

3795

PHOTINIA SERRULATA

A, H

3796

PHRAGMITES AUSTRALIS

A, H

3797

PHYLLANTHUS AMARUS

A, H

3798

PHYLLANTHUS EMBLICA

A, E, H

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

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

3799

PHYLLOSTACHYS NIGRA

A, E, H

3800

PHYSALIS ALKEKENGI

A, H

3801

PHYSALIS PUBESCENS

A, H

3802

PHYTANTRIOL

E

Only for use in topical medicines for dermal application.

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

3803

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%.

3804

PHYTOLACCA AMERICANA

A, H

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

3805

PHYTOMENADIONE

A, E

3806

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%.

3807

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%.

3808

PICEA ABIES

A, H

3809

PICEA MARIANA

A, H

3810

PICRASMA EXCELSA

A, E, H

3811

PICRORRHIZA KURROA

A, E, H

3812

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%.

3813

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%.

3814

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%.

3815

PIGMENT RED 4

E

Permitted for use only as a colour for topical use.

3816

PIGMENT RED 53

E

Permitted for use only as a colour for topical use.

3817

PIGMENT RED 57

E

Permitted for use only as a colour for topical use.

3818

PIGMENT RED 57 ALUMINIUM LAKE

E

Permitted for use only as a colour for topical use.

3819

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.

3820

PIGMENT RED 63

E

Permitted for use only as a colour for topical use.

3821

PIGMENT WHITE 26

E

Permitted for use only as a colour for topical use.

3822

PIGMENT YELLOW 12

E

Permitted for use only as a colour for topical use.

3823

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%.

3824

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%.

3825

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%.

3826

PIMENTA FRUIT OIL

A, E, H

3827

PIMENTA LEAF OIL

A, E, H

3828

PIMENTA OFFICINALIS

A, E, H

3829

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'.

3830

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).

3831

PIMPINELLA SAXIFRAGA

A, E, H

3832

PINE NEEDLE OIL SCOTCH

A, E, H

3833

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%.

3834

PINE OIL AROMATIC

A, E, H

3835

PINE OIL PUMILIO

A, E, H

3836

PINEAPPLE

E

3837

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%.

3838

PINELLIA TERNATA

A, H

3839

PINUS CONTORTA

A, E, H

3840

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%.

3841

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%.

3842

PINUS MONTICOLA

A, E, H

3843

PINUS MUGO

A, E, H

3844

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%.

3845

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%.

3846

PINUS PONDEROSA

A, E, H

3847

PINUS RADIATA

A, E, H

3848

PINUS STROBUS

A, E, H

3849

PINUS SYLVESTRIS

A, E, H

3850

PINUS TABULIFORMIS

A, E, H

3851

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%.

3852

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%.

3853

PIPER CHABA

A, E, H

3854

PIPER CUBEBA

A, E, H

3855

PIPER KADSURA

A, E, H

3856

PIPER LONGUM

A, E, H

3857

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.

3858

PIPER NIGRUM

A, E, H

3859

PIPER SARMENTOSUM

A, E, H

3860

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%.

3861

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%.

3862

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%.

3863

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%.

3864

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).

3865

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.

3866

PISCIDIA PISCIPULA

A, E, H

3867

PISTACIA LENTISCUS

A, E, H

3868

PISUM SATIVUM

A, E, H

3869

PLACENTA

H

Only for use as an active homoeopathic ingredient.

3870

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).

3871

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).

3872

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).

3873

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).

3874

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).

3875

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).

3876

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).

3877

PLATANUS OCCIDENTALIS

A, E, H

3878

PLATANUS RACEMOSA

A, H

3879

PLATANUS X ACERIFOLIA

A, H

3880

PLATYCODON GRANDIFLORUS

A, E, H

3881

PLECTRANTHUS BARBATUS

A, E, H

3882

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%.

3883

PLUM

E

3884

PLUMBAGO EUROPAEA

A, H

3885

PLUMERIA ALBA

A, E, H

3886

PLUMERIA RUBRA

A, E, H

3887

POA NEMORALIS

A, H

3888

POA PRATENSIS

A, H

3889

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%.

3890

POGOSTEMON CABLIN

A, E, H

3891

POLACRILIN

E

3892

POLACRILIN POTASSIUM

E

3893

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).

3894

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.

3895

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.

3896

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.

3897

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).

3898

POLOXAMER

E

Only for use in topical medicines for dermal application.

3899

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%.

3900

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%.

3901

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%.

3902

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%.

3903

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%.

3904

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%.

3905

POLYACRYLIC ACID

E

3906

POLYAMINO SUGAR CONDENSATE

E

Only for use in topical medicines for dermal application.

3907

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%.

3908

POLYBUTENE

E

Only for use in topical medicines for dermal application.

3909

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%.

3910

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%.

3911

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%.

3912

POLYDEXTROSE

E

3913

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%.

3914

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%

3915

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%.

3916

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%.

3917

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%.

3918

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%.

3919

POLYETHYLENE

E

3920

POLYGALA CHINENSIS

A, H

3921

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.

3922

POLYGALA SIBIRICA

A, E, H

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

3923

POLYGALA TENUIFOLIA

A

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

3924

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%.

3925

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%.

3926

POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE

E

Only for use in topical medicines for dermal application. 

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

3927

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%.

3928

POLYGLYCERYL-2-PEG-4 STEARATE

E

Only for use in topical medicines for dermal application.

3929

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%.

3930

POLYGLYCERYL-3 DIISOSTEARATE

E

Only for use in topical medicines for dermal application.

3931

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%.

3932

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%.

3933

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%.

3934

POLYGLYCERYL-3 POLYRICINOLEATE

E

3935

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%.

3936

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%.

3937

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%.

3938

POLYGLYCERYL-4 OLEATE

E

Only for use in topical medicines for dermal application.

3939

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%.

3940

POLYGLYCERYL-6 RICINOLEATE

E

Only for use in topical medicines for dermal application.

3941

POLYGONATUM MULTIFLORUM

A, H

3942

POLYGONATUM OFFICINALE

A, H

3943

POLYGONATUM SIBIRICUM

A, E, H

3944

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%.

3945

POLYGONUM BISTORTA

A, H

3946

POLYGONUM ODORATUM

A, H

3947

POLYHYDROXYSTEARIC ACID

E

Only for use in topical medicines for dermal application.

3948

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.

3949

POLYISOPRENE

E

Only for use in topical medicines for dermal application.

3950

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%.

3951

POLYMETHACRYLIC ACID

E

3952

POLYMETHYL METHACRYLATE

E

Only for use in topical medicines for dermal application.

3953

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%.

3954

POLYPORUS UMBELLATUS

A, H

3955

POLYPROPYLENE

E

Only for use in topical medicines for dermal application.

3956

POLYQUATERNIUM-10

E

Only for use in topical medicines for dermal application.

3957

POLYQUATERNIUM-11

E

Only for use in topical medicines for dermal application.

3958

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%.

3959

POLYQUATERNIUM-24

E

Only for use in topical medicines for dermal application.

3960

POLYQUATERNIUM-28

E

Only for use in topical medicines for dermal application.

3961

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%.

3962

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%.

3963

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%.

3964

POLYQUATERNIUM-7

E

Only for use in topical medicines for dermal application.

3965

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%

3966

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%.

3967

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%.

3968

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%.

3969

POLYSORBATE 20

E

3970

POLYSORBATE 40

E

3971

POLYSORBATE 60

E

3972

POLYSORBATE 65

E

3973

POLYSORBATE 80

E

3974

POLYSORBATE 85

E

Only for use in topical medicines for dermal application.

3975

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%.

3976

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.

3977

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%.

3978

POLYVINYL ACETATE

E

Only for use when the dosage form is chewing gum.

3979

POLYVINYL ACETATE PHTHALATE

E

3980

POLYVINYL ALCOHOL

E

3981

POLYVINYL CHLORIDE

E

Only for use in topical medicines for dermal application.

3982

POMEGRANATE

E

3983

PONCEAU SX

E

Permitted for use only as a colour for topical use.

3984

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.

3985

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%.

3986

POPPY SEED

E, H

3987

POPPY SEED OIL

E, H

3988

POPULUS ALBA

A, H

3989

POPULUS BALSAMIIFERA

A, E, H

3990

POPULUS CANDICANS

A, H

3991

POPULUS DELTOIDES

A, H

3992

POPULUS NIGRA

A, H

3993

POPULUS TREMULA

A, H

3994

POPULUS TREMULOIDES

A, H

3995

PORCINE

H

Only for use as an active homoeopathic ingredient. 

3996

PORIA COCOS

A, E, H

3997

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%.

3998

PORTULACA OLERACEA

A, E, H

3999

POTABLE WATER

E

4000

POTASSIUM ACETATE

E

4001

POTASSIUM ARSENITE

H

Only for use as an active homoeopathic ingredient.

4002

POTASSIUM ASCORBATE

A, E, H

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

4003

POTASSIUM ASCORBATE DIHYDRATE

A, E, H

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

4004

POTASSIUM ASCORBYL TOCOPHERYL PHOSPHATE

E

Only for use in topical medicines for dermal application.

4005

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.

4006

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.

4007

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.

4008

POTASSIUM BICARBONATE

E

4009

POTASSIUM BROMIDE

H

Only for use as an active homoeopathic ingredient. 

4010

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.

4011

POTASSIUM CETYL PHOSPHATE

E

Only for use in topical medicines for dermal application.

4012

POTASSIUM CHLORIDE

A, E, H

When for oral use:

a) potassium is a mandatory component of potassium chloride;

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

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

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

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

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

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

c) the medicine requires the warning statements:

- (UOAD) 'Use only as directed'

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

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

4013

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.

4014

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%.

4015

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%.

4016

POTASSIUM DICHROMATE

H

Only for use as an active homoeopathic ingredient.

4017

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.

4018

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.

4019

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.

4020

POTASSIUM HYDROXYCITRATE

A, H

4021

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.

4022

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.

4023

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%.

4024

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%.

4025

POTASSIUM NITRATE

A, H

Only for dental use.

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

4026

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.

4027

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%.

4028

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.

4029

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%.

4030

POTASSIUM STEARATE

E

Only for use in topical medicines for dermal application.

4031

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.

4032

POTATO STARCH

E

4033

POTENTILLA ANSERINA

A, H

4034

POTENTILLA CHINENSIS

A, H

4035

POTENTILLA DISCOLOR

A, H

4036

POTENTILLA ERECTA

A, E, H

4037

POTENTILLA REPTANS

A, H

4038

POTERIUM OFFICINALE

A, E, H

4039

POTERIUM SANGUISORBA

A, H

4040

POVIDONE

E

4041

POWDERED CELLULOSE

E

4042

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%.

4043

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%.

4044

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%.

4045

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%.

4046

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%.

4047

PPG-2 LANOLIN ALCOHOL ETHER

E

Only for use in topical medicines for dermal application.

4048

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%.

4049

PPG-20 LANOLIN ALCOHOL ETHER

E

Only for use in topical medicines for dermal application.

4050

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%.

4051

PPG-20 METHYL GLUCOSE ETHER DISTEARATE

E

Only for use in topical medicines for dermal application.

4052

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%.

4053

PPG-3 MYRISTYL ETHER

E

Only for use in topical medicines for dermal application.

4054

PPG-5-CETETH-20

E

Only for use in topical medicines for dermal application.

4055

PPG-5-LAUROMACROGOL 250

E

Only for use in topical medicines for dermal application.

4056

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%.

4057

PREGELATINISED MAIZE STARCH

E

4058

PREGELATINISED POTATO STARCH

E

4059

PREGELATINISED RICE STARCH

E

4060

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).

4061

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%.

4062

PRICKLY ASH BARK DRY

A, H

4063

PRICKLY ASH BARK POWDER

A, H

4064

PRIMULA VERIS

A, E, H

4065

PRIMULA VULGARIS

A, E, H

4066

PRINSEPIA UNIFLORA

A, H

4067

PROBOSCIDEA PARVIFLORA

A, H

4068

PROGESTERONE

H

Only for use as an active homoeopathic ingredient. 

4069

PROLINE

A, E