3598

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%.

3599

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%.

3600

PADIMATE O

A

Only for use as an active ingredient in sunscreens for dermal application and not to be included in medicines intended for use in the eye.

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

When used in primary sunscreen products and listed in the Register on or after 1 January 2018, the medicine must have the following statements on the medicine label:

- (AVOID) 'Avoid prolonged exposure in the sun' (or words to this effect); and

- (SUNPRO) 'Wear protective clothing - hats and eyewear when exposed to the sun' (or words to this effect).

When used in primary sunscreen products and listed in the Register before 1 January 2018, the medicine requires the following statements on the medicine label if supplied after 1 July 2019:

- (AVOID) 'Avoid prolonged exposure in the sun' (or words to this effect); and

- (SUNPRO) 'Wear protective clothing - hats and eyewear when exposed to the sun' (or words to this effect).

3601

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%.

3602

PAEONIA LACTIFLORA

A, E, H

3603

PAEONIA OBOVATA

A, H

3604

PAEONIA SUFFRUTICOSA

A, E, H

3605

PAEONIA VEITCHII

A, H

3606

PALIURUS SPINA-CHRISTI

A, H

3607

PALLADIUM

H

Only for use as an active homoeopathic ingredient.

3608

PALM FRUIT OIL

A, E, H

3609

PALM GLYCERIDES

E

3610

PALM KERNEL OIL

A, E, H

3611

PALM TOCOTRIENOLS COMPLEX

A, H

3612

PALMARIA PALMATA

A, H

3613

PALMAROSA OIL

A, E, H

3614

PALMITIC ACID

E

3615

PALMITOLEIC ACID-RICH FATTY ACID ETHYL ESTERS

A

3616

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%.

3617

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%

3618

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%.

3619

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%.

3620

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%.

3621

PANAX GINSENG

A, E, H

3622

PANAX JAPONICUS

A, H

3623

PANAX NOTOGINSENG

A, H

3624

PANAX PSEUDOGINSENG

A, H

3625

PANAX QUINQUEFOLIUS

A, H

3626

PANICUM MILIACEUM

A, H

3627

PANTETHINE

E

Only for use in topical medicines for dermal application.

3628

PANTHENOL

A, E

3629

PANTHENYL ETHYL ETHER

E

Only for use in topical medicines for dermal application.

3630

PANTOLACTONE

E

3631

PANTOTHENIC ACID

A, E

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

3632

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%.

3633

PAPAIN

A, E

3634

PAPER

E

Only for use in topical medicines for dermal application.

3635

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%.

3636

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%.

3637

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%.

3638

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%.

3639

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%.

3640

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%.

3641

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%.

3642

PARA-ETHYLPHENOL

E

Permitted for use only in combination with other permitted ingredients as part of a flavour proprietary excipient formulation.

The maximum recommended daily dose must contain no more than 0.12 mg of para-ethylphenol.

The total flavour proprietary excipient formulation in a medicine must be no more than 5%.

3643

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%.

3644

PARA-HYDROXYBENZOIC ACID

E

3645

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%.

3646

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%.

3647

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%.

3648

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%.

3649

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%.

3650

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%.

3651

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%.

3652

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%.

3653

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%.

3654

PARAMERIA LAEVIGATA

A, H

3655

PARIETARIA JUDAICA

A, H

3656

PARIS POLYPHYLLA

A, H

3657

PARIS QUADRIFOLIA

A, H

3658

PARSLEY

E, H

3659

PARSLEY HERB DRY

A, E, H

3660

PARSLEY HERB OIL

A, E, H

3661

PARSLEY HERB POWDER

A, E, H

3662

PARSLEY SEED OIL

A, E, H

3663

PARTHENOCISSUS TRICUSPIDATA

A, H

3664

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%.

3665

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%.

3666

PASPALUM NOTATUM

A, H

3667

PASSIFLORA CAERULEA

A, H

3668

PASSIFLORA EDULIS

E

3669

PASSIFLORA HERB DRY

A, H

3670

PASSIFLORA INCARNATA

A, E, H

3671

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%.

3672

PATENT BLUE V

E

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

3673

PATENT BLUE V ALUMINIUM LAKE

E

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

3674

PATRINIA SCABIOSIFOLIA

A, H

3675

PATRINIA VILLOSA

A, H

3676

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]’.

3677

PAULLINIA PINNATA

A, H

3678

PAWPAW

E

3679

PEA

E

3680

PEA STARCH

E

3681

PEACH

E

3682

PEANUT

E

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

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

3683

PEAR

E

3684

PECAN

E

3685

PECTIN

A, E

3686

PEG-10 SOYA STEROL

E

Only for use in topical medicines for dermal application.

3687

PEG-100 STEARATE

E

Only for use in topical medicines for dermal application.

3688

PEG-12 DILAURATE

E

3689

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%.

3690

PEG-120 METHYL GLUCOSE DIOLEATE

E

Only for use in topical medicines for dermal application.

3691

PEG-120 STEARATE

E

Only for use in topical medicines for dermal application.

3692

PEG-15 COCAMINE

E

Only for use in topical medicines for dermal application.

3693

PEG-150 DISTEARATE

E

Only for use in topical medicines for dermal application.

3694

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%.

3695

PEG-20 METHYL GLUCOSE DISTEARATE

E

Only for use in topical medicines for dermal application.

3696

PEG-20 METHYL GLUCOSE SESQUISTEARATE

E

Only for use in topical medicines for dermal application.

3697

PEG-20 SORBITAN ISOSTEARATE

E

Only for use in topical medicines for dermal application.

3698

PEG-20 STEARATE

E

Only for use in topical medicines for dermal application.

3699

PEG-25 PABA

A

Only for use as an active ingredient in sunscreens for dermal application and not to be included in medicines intended for use in the eye.

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

When used in primary sunscreen products and listed in the Register on or after 1 January 2018, the medicine must have the following statements on the medicine label:

- (AVOID) 'Avoid prolonged exposure in the sun' (or words to this effect); and

- (SUNPRO) 'Wear protective clothing - hats and eyewear when exposed to the sun' (or words to this effect).

When used in primary sunscreen products and listed in the Register before 1 January 2018, the medicine requires the following statements on the medicine label if supplied after 1 July 2019:

- (AVOID) 'Avoid prolonged exposure in the sun' (or words to this effect); and

- (SUNPRO) 'Wear protective clothing - hats and eyewear when exposed to the sun' (or words to this effect).

3700

PEG-30 DIPOLYHYDROXYSTEARATE

E

Only for use in topical medicines for dermal application.

3701

PEG-30 STEARATE

E

Only for use in topical medicines for dermal application.

3702

PEG-35 CASTOR OIL

E

3703

PEG-4 DILAURATE

E

Only for use in topical medicines for dermal application.

3704

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%.

3705

PEG-4 STEARATE

E

Only for use in topical medicines for dermal application.

3706

PEG-40 CASTOR OIL

E

3707

PEG-40 HYDROGENATED CASTOR OIL

E

3708

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%.

3709

PEG-40 STEARATE

E

Only for use in topical medicines for dermal application.

3710

PEG-45/DODECYL GLYCOL COPOLYMER

E

Only for use in topical medicines for dermal application.

3711

PEG-5 GLYCERYL STEARATE

E

Only for use in topical medicines for dermal application.

3712

PEG-50 STEARATE

E

Only for use in topical medicines for dermal application.

3713

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%.

3714

PEG-6 LAURAMIDE

E

Only for use in topical medicines for dermal application.

3715

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%.

3716

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%.

3717

PEG-60 HYDROGENATED CASTOR OIL

E

Only for use in topical medicines for dermal application.

3718

PEG-7 COCAMIDE

E

Only for use in topical medicines for dermal application.

3719

PEG-7 GLYCERYL COCOATE

E

Only for use in topical medicines for dermal application.

3720

PEG-7 HYDROGENATED CASTOR OIL

E

Only for use in topical medicines for dermal application.

3721

PEG-75 LANOLIN

E

Only for use in topical medicines for dermal application.

3722

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%.

3723

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%.

3724

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%.

3725

PEG-8 DISTEARATE

E

Only for use in topical medicines for dermal application.

3726

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.

3727

PEG-8 PROPYLENE GLYCOL COCOATE

E

3728

PEG-8 STEARATE

E

Only for use in topical medicines for dermal application.

3729

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%.

3730

PELARGONIUM GRAVEOLENS

A, E, H

3731

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%.

3732

PELTIGERA CANINA

A, H

3733

PENICILLIUM EXPANSUM

A, H

3734

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.

3735

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%

3736

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%.

3737

PENTAERYTHRITYL TETRALAURATE

E

Only for use in topical medicines for dermal application.

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

3738

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%.

3739

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%.

3740

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%.

3741

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%.

3742

PEPPER BLACK

E, H

3743

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%.

3744

PEPPER WHITE

E, H

3745

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%.

3746

PEPPERMINT LEAF DRY

A, E, H

3747

PEPPERMINT LEAF POWDER

A, E, H

3748

PEPPERMINT OIL

A, E, H

3749

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%.

3750

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%.

3751

PERFLUOROPOLYMETHYLISOPROPYL ETHER

E

Only for use in topical medicines for dermal application.

3752

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%.

3753

PERILLA FRUTESCENS

A, E, H

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

3754

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%.

3755

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%.

3756

PERMETHRIN

E

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

3757

PERSEA AMERICANA

A, E, H

3758

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%.

3759

PERSICARIA CHINENSIS

A, H

3760

PERSICARIA TINCTORIA

A, H

3761

PERSIMMON

E

3762

PERU BALSAM

A, E, H

3763

PERU BALSAM OIL

A, E, H

3764

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%

3765

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%.

3766

PETITGRAIN OIL CITRONNIER

E

Permitted for use only in combination with other permitted ingredients as part of a fragrance proprietary excipient formulation.

When included in a medicine for use on the lips the concentration of petitgrain oil citronnier must be no more than 0.1%.

When included in dermal creams for infant use the concentration of petitgrain oil citronnier must be no more than 0.5%

The total fragrance proprietary excipient formulation in a medicine must be no more than 1%.

3767

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.

3768

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%.

3769

PETROSELINUM CRISPUM

A, E, H

3770

PEUCEDANUM PRAERUPTORUM

A, E, H

3771

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).

3772

PHALARIS ARUNDINACEA

A, H

3773

PHALARIS CANARIENSIS

A, H

3774

PHASEOLUS COCCINEUS

A, H

3775

PHASEOLUS VULGARIS

A, H

3776

PHELLINUS ROBINIAE

A, E, H

3777

PHELLODENDRON AMURENSE

A, E, H

3778

PHELLODENDRON CHINENSE

A, H

3779

PHENACETIN

E

Only for use in topical medicines for dermal application.

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

3780

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%.

3781

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%.

3782

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%.

3783

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%.

3784

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%

3785

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%.

3786

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%.

3787

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%.

3788

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%.

3789

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%.

3790

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%.

3791

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).

3792

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%.

3793

PHENOXYETHYLPARABEN

E

Only for use in topical medicines for dermal application.

3794

PHENYL DIMETHICONE

E

Only for use in topical medicines for dermal application.

3795

PHENYL TRIMETHICONE

E

Only for use in topical medicines for dermal application.

3796

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%.

3797

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%.

3798

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%.

3799

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%.

3800

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'.

3801

PHENYLBENZIMIDAZOLE SULFONIC ACID

A

Only for use as an active ingredient in sunscreens for dermal application and not to be included in medicines intended for use in the eye.

The concentration in the medicine must be no more than 4%.

When used in primary sunscreen products and listed in the Register on or after 1 January 2018, the medicine must have the following statements on the medicine label:

- (AVOID) 'Avoid prolonged exposure in the sun' (or words to this effect); and

- (SUNPRO) 'Wear protective clothing - hats and eyewear when exposed to the sun' (or words to this effect).

When used in primary sunscreen products and listed in the Register before 1 January 2018, the medicine requires the following statements on the medicine label if supplied after 1 July 2019:

- (AVOID) 'Avoid prolonged exposure in the sun' (or words to this effect); and

- (SUNPRO) 'Wear protective clothing - hats and eyewear when exposed to the sun' (or words to this effect).

3802

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%.

3803

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%.

3804

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%.

3805

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%.

3806

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%.

3807

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%.

3808

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%.

3809

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%.

3810

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%.

3811

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%.

3812

PHLEUM PRATENSE

A, H

3813

PHLOXINE B

E

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

3814

PHLOXINE B ALUMINIUM LAKE

E

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

3815

PHOENIX DACTYLIFERA

A, E, H

3816

PHOSPHATIDYL CHOLINE

E

3817

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%.

3818

PHOSPHORIC ACID

E, H

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

3819

PHOSPHORUS

H

Only for use as an active homoeopathic ingredient. 

3820

PHOTINIA SERRULATA

A, H

3821

PHRAGMITES AUSTRALIS

A, H

3822

PHYLLANTHUS AMARUS

A, H

3823

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.

3824

PHYLLOSTACHYS NIGRA

A, E, H

3825

PHYSALIS ALKEKENGI

A, H

3826

PHYSALIS PUBESCENS

A, H

3827

PHYTANTRIOL

E

Only for use in topical medicines for dermal application.

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

3828

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%.

3829

PHYTOLACCA AMERICANA

A, H

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

3830

PHYTOMENADIONE

A, E

3831

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%.

3832

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%.

3833

PICEA ABIES

A, H

3834

PICEA MARIANA

A, H

3835

PICRASMA EXCELSA

A, E, H

3836

PICRORRHIZA KURROA

A, E, H

3837

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%.

3838

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%.

3839

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%.

3840

PIGMENT RED 4

E

Permitted for use only as a colour for topical use.

3841

PIGMENT RED 53

E

Permitted for use only as a colour for topical use.

3842

PIGMENT RED 57

E

Permitted for use only as a colour for topical use.

3843

PIGMENT RED 57 ALUMINIUM LAKE

E

Permitted for use only as a colour for topical use.

3844

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.

3845

PIGMENT RED 63

E

Permitted for use only as a colour for topical use.

3846

PIGMENT WHITE 26

E

Permitted for use only as a colour for topical use.

3847

PIGMENT YELLOW 12

E

Permitted for use only as a colour for topical use.

3848

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%.

3849

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%.

3850

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%.

3851

PIMENTA FRUIT OIL

A, E, H

3852

PIMENTA LEAF OIL

A, E, H

3853

PIMENTA OFFICINALIS

A, E, H

3854

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'.

3855

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).

3856

PIMPINELLA SAXIFRAGA

A, E, H

3857

PINE NEEDLE OIL SCOTCH

A, E, H

3858

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%.

3859

PINE OIL AROMATIC

A, E, H

3860

PINE OIL PUMILIO

A, E, H

3861

PINEAPPLE

E

3862

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%.

3863

PINELLIA TERNATA

A, H

3864

PINUS CONTORTA

A, E, H

3865

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%.

3866

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%.

3867

PINUS MONTICOLA

A, E, H

3868

PINUS MUGO

A, E, H

3869

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%.

3870

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%.

3871

PINUS PONDEROSA

A, E, H

3872

PINUS RADIATA

A, E, H

3873

PINUS STROBUS

A, E, H

3874

PINUS SYLVESTRIS

A, E, H

3875

PINUS TABULIFORMIS

A, E, H

3876

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%.

3877

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%.

3878

PIPER CHABA

A, E, H

3879

PIPER CUBEBA

A, E, H

3880

PIPER KADSURA

A, E, H

3881

PIPER LONGUM

A, E, H

3882

PIPER METHYSTICUM

A, H

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

Only for oral use when the dosage form is ‘tablet’ or ‘capsule’; or when the container type is ‘tea bag’.

When used in oral medicines, the maximum daily dose of kavalactones (of Piper methysticum) must be no more than 250 mg.

If the dosage form is tablet or capsule then the quantity of kavalactones (of Piper methysticum) must be no more than 125 mg per tablet or capsule.

Oral medicines containing more than 25 mg of kavalactones (of Piper methysticum) per dose require the following warning statement on the medicine label:

- (PIPER) 'Not for prolonged use. If symptoms persist - seek advice from a healthcare practitioner. Not recommended for pregnant or lactating women (or words to that effect). May harm the liver.'

The plant part must be root or rhizome.

When for oral use, the 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.

3883

PIPER NIGRUM

A, E, H

3884

PIPER SARMENTOSUM

A, E, H

3885

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%.

3886

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%.

3887

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%.

3888

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%.

3889

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).

3890

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.

3891

PISCIDIA PISCIPULA

A, E, H

3892

PISTACIA LENTISCUS

A, E, H

3893

PISUM SATIVUM

A, E, H

3894

PLACENTA

H

Only for use as an active homoeopathic ingredient.

3895

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).

3896

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).

3897

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).

3898

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).

3899

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).

3900

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).

3901

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).

3902

PLATANUS OCCIDENTALIS

A, E, H

3903

PLATANUS RACEMOSA

A, H

3904

PLATANUS X ACERIFOLIA

A, H

3905

PLATYCODON GRANDIFLORUS

A, E, H

3906

PLECTRANTHUS BARBATUS

A, E, H

3907

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%.

3908

PLUM

E

3909

PLUMBAGO EUROPAEA

A, H

3910

PLUMERIA ALBA

A, E, H

3911

PLUMERIA RUBRA

A, E, H

3912

POA NEMORALIS

A, H

3913

POA PRATENSIS

A, H

3914

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%.

3915

POGOSTEMON CABLIN

A, E, H

3916

POLACRILIN

E

3917

POLACRILIN POTASSIUM

E

3918

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).

3919

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.

3920

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.

3921

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.

3922

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).

3923

POLOXAMER

E

Only for use in topical medicines for dermal application.

3924

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%.

3925

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%.

3926

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%.

3927

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%.

3928

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%.

3929

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%.

3930

POLYACRYLIC ACID

E

3931

POLYAMINO SUGAR CONDENSATE

E

Only for use in topical medicines for dermal application.

3932

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%.

3933

POLYBUTENE

E

Only for use in topical medicines for dermal application.

3934

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%.

3935

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%.

3936

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%.

3937

POLYDEXTROSE

E

3938

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%.

3939

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%

3940

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%.

3941

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%.

3942

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%.

3943

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%.

3944

POLYETHYLENE

E

3945

POLYGALA CHINENSIS

A, H

3946

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.

3947

POLYGALA SIBIRICA

A, E, H

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

3948

POLYGALA TENUIFOLIA

A

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

3949

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%.

3950

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%.

3951

POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE

E

Only for use in topical medicines for dermal application. 

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

3952

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%.

3953

POLYGLYCERYL-2-PEG-4 STEARATE

E

Only for use in topical medicines for dermal application.

3954

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%.

3955

POLYGLYCERYL-3 DIISOSTEARATE

E

Only for use in topical medicines for dermal application.

3956

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%.

3957

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%.

3958

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%.

3959

POLYGLYCERYL-3 POLYRICINOLEATE

E

3960

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%.

3961

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%.

3962

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%.

3963

POLYGLYCERYL-4 OLEATE

E

Only for use in topical medicines for dermal application.

3964

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%.

3965

POLYGLYCERYL-6 RICINOLEATE

E

Only for use in topical medicines for dermal application.

3966

POLYGONATUM MULTIFLORUM

A, H

3967

POLYGONATUM OFFICINALE

A, H

3968

POLYGONATUM SIBIRICUM

A, E, H

3969

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%.

3970

POLYGONUM BISTORTA

A, H

3971

POLYGONUM ODORATUM

A, H

3972

POLYHYDROXYSTEARIC ACID

E

Only for use in topical medicines for dermal application.

3973

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.

3974

POLYISOPRENE

E

Only for use in topical medicines for dermal application.

3975

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%.

3976

POLYMETHACRYLIC ACID

E

3977

POLYMETHYL METHACRYLATE

E

Only for use in topical medicines for dermal application.

3978

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%.

3979

POLYPORUS UMBELLATUS

A, H

3980

POLYPROPYLENE

E

Only for use in topical medicines for dermal application.

3981

POLYPROPYLENE GLYCOL

E

Permitted for use only in combination with other permitted ingredients as part of a flavour or fragrance proprietary excipient formulation.

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

When used in a fragrance, the total fragrance proprietary excipient formulation in a medicine must be no more than 1%.

3982

POLYQUATERNIUM-10

E

Only for use in topical medicines for dermal application.

3983

POLYQUATERNIUM-11

E

Only for use in topical medicines for dermal application.

3984

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%.

3985

POLYQUATERNIUM-24

E

Only for use in topical medicines for dermal application.

3986

POLYQUATERNIUM-28

E

Only for use in topical medicines for dermal application.

3987

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%.

3988

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%.

3989

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%.

3990

POLYQUATERNIUM-7

E

Only for use in topical medicines for dermal application.

3991

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%

3992

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%.

3993

POLYSILICONE-15

A

Only for use as an active ingredient in sunscreens for dermal application and not to be included in medicines intended for use in the eye.

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

When used in primary sunscreen products and listed in the Register on or after 1 January 2018, the medicine must have the following statements on the medicine label:

- (AVOID) 'Avoid prolonged exposure in the sun' (or words to this effect); and

- (SUNPRO) 'Wear protective clothing - hats and eyewear when exposed to the sun' (or words to this effect).

When used in primary sunscreen products and listed in the Register before 1 January 2018, the medicine requires the following statements on the medicine label if supplied after 1 July 2019:

- (AVOID) 'Avoid prolonged exposure in the sun' (or words to this effect); and

- (SUNPRO) 'Wear protective clothing - hats and eyewear when exposed to the sun' (or words to this effect).

3994

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%.

3995

POLYSORBATE 20

E

3996

POLYSORBATE 40

E

3997

POLYSORBATE 60

E

3998

POLYSORBATE 65

E

3999

POLYSORBATE 80

E

4000

POLYSORBATE 85

E

Only for use in topical medicines for dermal application.

4001

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%.

4002

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.

4003

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%.

4004

POLYVINYL ACETATE

E

Only for use when the dosage form is chewing gum.

4005

POLYVINYL ACETATE PHTHALATE

E

4006

POLYVINYL ALCOHOL

E

4007

POLYVINYL CHLORIDE

E

Only for use in topical medicines for dermal application.

4008

POMEGRANATE

E

4009

PONCEAU SX

E

Permitted for use only as a colour for topical use.

4010

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.

4011

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%.

4012

POPPY SEED

E, H

4013

POPPY SEED OIL

E, H

4014

POPULUS ALBA

A, H

4015

POPULUS BALSAMIIFERA

A, E, H

4016

POPULUS CANDICANS

A, H

4017

POPULUS DELTOIDES

A, H

4018

POPULUS NIGRA

A, H

4019

POPULUS TREMULA

A, H

4020

POPULUS TREMULOIDES

A, H

4021

PORCINE

H

Only for use as an active homoeopathic ingredient. 

4022

PORIA COCOS

A, E, H

4023

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%.

4024

PORTULACA OLERACEA

A, E, H

4025

POTABLE WATER

E

4026

POTASSIUM ACETATE

E

4027

POTASSIUM ARSENITE

H

Only for use as an active homoeopathic ingredient.

4028

POTASSIUM ASCORBATE

A, E, H

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

4029

POTASSIUM ASCORBATE DIHYDRATE

A, E, H

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

4030

POTASSIUM ASCORBYL TOCOPHERYL PHOSPHATE

E

Only for use in topical medicines for dermal application.

4031

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.

4032

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.

4033

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.

4034

POTASSIUM BICARBONATE

E

4035

POTASSIUM BROMIDE

H

Only for use as an active homoeopathic ingredient. 

4036

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.

4037

POTASSIUM CETYL PHOSPHATE

E

Only for use in topical medicines for dermal application.

4038

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%.

4039

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.

4040

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%.

4041

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%.

4042

POTASSIUM DICHROMATE

H

Only for use as an active homoeopathic ingredient.

4043

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.

4044

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.

4045

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.

4046

POTASSIUM HYDROXYCITRATE

A, H

4047

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.

4048

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

4049

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%.

4050

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%.

4051

POTASSIUM NITRATE

A, H

Only for dental use.

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

4052

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.

4053

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%.

4054

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.

4055

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%.

4056

POTASSIUM STEARATE

E

Only for use in topical medicines for dermal application.

4057

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.

4058

POTATO STARCH

E

4059

POTENTILLA ANSERINA

A, H

4060

POTENTILLA CHINENSIS

A, H

4061

POTENTILLA DISCOLOR

A, H

4062

POTENTILLA ERECTA

A, E, H

4063

POTENTILLA REPTANS

A, H

4064

POTERIUM OFFICINALE

A, E, H

4065

POTERIUM SANGUISORBA

A, H

4066

POVIDONE

E

4067

POWDERED CELLULOSE

E

4068

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%.

4069

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%.

4070

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%.

4071

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%.

4072

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%.

4073

PPG-2 LANOLIN ALCOHOL ETHER

E

Only for use in topical medicines for dermal application.

4074

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%.

4075

PPG-20 LANOLIN ALCOHOL ETHER

E

Only for use in topical medicines for dermal application.

4076

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%.

4077

PPG-20 METHYL GLUCOSE ETHER DISTEARATE

E

Only for use in topical medicines for dermal application.

4078

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%.

4079

PPG-3 MYRISTYL ETHER

E

Only for use in topical medicines for dermal application.

4080

PPG-5-CETETH-20

E

Only for use in topical medicines for dermal application.

4081

PPG-5-LAUROMACROGOL 250

E

Only for use in topical medicines for dermal application.

4082

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%.

4083

PREGELATINISED MAIZE STARCH

E

4084

PREGELATINISED POTATO STARCH

E

4085

PREGELATINISED RICE STARCH

E

4086

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).

4087

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%.

4088

PRICKLY ASH BARK DRY

A, H

4089

PRICKLY ASH BARK POWDER

A, H

4090

PRIMULA VERIS

A, E, H

4091

PRIMULA VULGARIS

A, E, H

4092

PRINSEPIA UNIFLORA

A, H

4093

PROBOSCIDEA PARVIFLORA

A, H

4094

PROGESTERONE

H

Only for use as an active homoeopathic ingredient. 

4095

PROLINE

A, E

4096

PROPAN-1-OL

E

Only for use in topical medicines for dermal application.

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

4097

PROPANE

E

Only for use as an excipient propellant ingredient.

4098

PROPANEDIOL

E

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

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

4099

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%.

4100

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%.

4101

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%.