Federal Register of Legislation - Australian Government

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Determinations/Health as made
This instrument repeals and replaces the Therapeutic Goods (Permissible Ingredients) Determination (No. 1) 2021 and specifies those ingredients that may be contained in a medicine that may be listed in the Australian Register of Therapeutic Goods under section 26A or 26AE of the Therapeutic Goods Act 1989, and requirements in relation to the inclusion of those ingredients in such medicines.
Administered by: Health
Registered 13 Aug 2021
Tabling HistoryDate
Tabled HR23-Aug-2021
Tabled Senate23-Aug-2021
Date of repeal 25 Oct 2021
Repealed by Therapeutic Goods (Permissible Ingredients) Determination (No. 3) 2021
Table of contents.

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

Note:       See sections 5 and 6.

Permissible ingredients and requirements

Column 1

Column 2

Column 3

Column 4

Item

Ingredient name

Purpose

Specific requirements

3646

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%.

 

3647

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%.

 

3648

PADIMATE O

A

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

The concentration in the medicine must not be more than 8%.

When used in primary sunscreen products, the following warning statements are required on the label:

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

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

 

3649

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%.

 

3650

PAEONIA LACTIFLORA

A, E, H

 

3651

PAEONIA OBOVATA

A, H

 

3652

PAEONIA SUFFRUTICOSA

A, E, H

 

3653

PAEONIA VEITCHII

A, H

 

3654

PALIURUS SPINA-CHRISTI

A, H

 

3655

PALLADIUM

H

Only for use as an active homoeopathic ingredient.

 

3656

PALM FRUIT OIL

A, E, H

 

3657

PALM GLYCERIDES

E

 

3658

PALM KERNEL OIL

A, E, H

 

3659

PALM TOCOTRIENOLS COMPLEX

A, H

 

3660

PALMARIA PALMATA

A, H

 

3661

PALMAROSA OIL

A, E, H

 

3662

PALMIDROL

A

Only to be used in a medicine where Pharmako Biotechnologies Pty Ltd (Client ID 62358), who applied to have the ingredient included in this Determination, is the sponsor of the medicine or has given written authorisation to the sponsor of a medicine to include the ingredient in the medicine. This paragraph ceases to be a requirement for this ingredient after 02 December 2021.

Only permitted for use in medicines limited to oral routes of administration.

The maximum recommended daily dose of the medicine must not provide more than 600 mg of palmidrol.

The following warning statements (or words to the same effect) are required on the medicine label:

- (ANALG) 'The medicine may interact with other prescription analgesic medicines, please consult your healthcare practitioner before use.'

- (ADULT) ‘Adults only.’

- (21DAYS) ‘Not to be used for more than 21 consecutive days.’

 

3663

PALMITIC ACID

E

 

3664

PALMITOLEIC ACID-RICH FATTY ACID ETHYL ESTERS

A

 

3665

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%.

 

3666

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%

 

3667

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%.

 

3668

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%.

 

3669

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%.

 

3670

PANAX GINSENG

A, E, H

 

3671

PANAX JAPONICUS

A, H

 

3672

PANAX NOTOGINSENG

A, H

 

3673

PANAX PSEUDOGINSENG

A, H

 

3674

PANAX QUINQUEFOLIUS

A, H

 

3675

PANICUM MILIACEUM

A, H

 

3676

PANTETHINE

E

Only for use in topical medicines for dermal application.

 

3677

PANTHENOL

A, E

 

3678

PANTHENYL ETHYL ETHER

E

Only for use in topical medicines for dermal application.

 

3679

PANTOLACTONE

E

 

3680

PANTOTHENIC ACID

A, E

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

 

3681

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%.

 

3682

PAPAIN

A, E

 

3683

PAPER

E

Only for use in topical medicines for dermal application.

 

3684

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%.

 

3685

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%.

 

3686

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%.

 

3687

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%.

 

3688

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%.

 

3689

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%.

 

3690

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%.

 

3691

PARA-ETHYL CRESOXYACETATE

E

Para-ethyl cresoxyacetate must only be included in medicines when in combination with other permitted ingredients as a fragrance proprietary excipient formulation.

The total concentration of the fragrance proprietary excipient formulation containing para-ethyl cresoxyacetate must not be more than 1% of the total medicine.

 

3692

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%.

 

3693

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%.

 

3694

PARA-HYDROXYBENZOIC ACID

E

 

3695

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%.

 

3696

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%.

 

3697

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%.

 

3698

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%.

 

3699

PARA-PROPYL ANISOLE

E

Para-propyl anisole must only be included in medicines when in combination with other permitted ingredients as a fragrance and/or flavour proprietary excipient formulation.

 The total concentration of fragrance proprietary excipient formulations containing para-propyl anisole must not be more than 1% of the total medicine.

The total concentration of flavour proprietary excipient formulations containing para-propyl anisole must not be more than 5% of the total medicine.

 

3700

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%.

 

3701

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%.

 

3702

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%.

 

3703

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%.

 

3704

PARAMERIA LAEVIGATA

A, H

 

3705

PARIETARIA JUDAICA

A, H

 

3706

PARIS POLYPHYLLA

A, H

 

3707

PARIS QUADRIFOLIA

A, H

 

3708

PARSLEY

E, H

 

3709

PARSLEY HERB DRY

A, E, H

 

3710

PARSLEY HERB OIL

A, E, H

 

3711

PARSLEY HERB POWDER

A, E, H

 

3712

PARSLEY SEED OIL

A, E, H

 

3713

PARTHENOCISSUS TRICUSPIDATA

A, H

 

3714

PARTIALLY DEHYDRATED LIQUID SORBITOL

E

Sorbitol is a mandatory component of partially dehydrated liquid sorbitol.

Permitted for use only as part of the capsule in medicines where the dosage form is a soft capsule.

 

3715

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%.

 

3716

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%.

 

3717

PASPALUM NOTATUM

A, H

 

3718

PASSIFLORA CAERULEA

A, H

 

3719

PASSIFLORA EDULIS

E

 

3720

PASSIFLORA HERB DRY

A, H

 

3721

PASSIFLORA INCARNATA

A, E, H

 

3722

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%.

 

3723

PATENT BLUE V

E

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

 

3724

PATENT BLUE V ALUMINIUM LAKE

E

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

 

3725

PATRINIA SCABIOSIFOLIA

A, H

 

3726

PATRINIA VILLOSA

A, H

 

3727

PAULLINIA CUPANA

A, E, H

Caffeine is a mandatory component of Paullinia cupana.

When the medicine is packaged for supply as an undivided preparation and is for internal use or oral application, the medicine must not contain a concentration of total caffeine greater than 4%.

When the medicine is packaged for supply as a divided preparation and is for internal use or oral application, the medicine must not contain a concentration of total caffeine greater than 33%.

When for internal use or oral application, the maximum recommended daily dose of the medicine must provide no more than 400 mg of total caffeine.

When the medicine is packaged for supply as an undivided preparation and is for internal use or oral application, the medicine must not contain a concentration of total caffeine greater than 1%.

When the medicine is for internal use or oral application, a maximum recommended dose of the medicine must not provide more than 100 mg of total caffeine within a 3 hour period.

When the maximum recommended daily dose of the medicine provides greater than 10 mg of total caffeine and the medicine is for internal use or oral application, the following warning statements are required on the label:

- (ADULT) 'Adults only' (or words to that effect).

- (CAFF) 'Contains [state quantity per dosage unit or per mL or per gram of product] total caffeine [per dosage unit or per mL or per gram]. A cup of instant coffee contains approximately 80mg of caffeine.'

- (CAFFPREG) ‘Caffeine intake more than 200 mg per day is not recommended during pregnancy or breastfeeding.’

When the maximum recommended daily dose of the medicine provides greater than 80 mg of total caffeine and the medicines is for internal use or oral application, the following warning statements are required on the label:

- (CAFFLMT) 'Limit the use of caffeine-containing products (including tea and coffee) when taking this product.'

- (CAFFCYP) ‘Caffeine interacts with enzyme CYP1A2 in the liver. Consult your health professional before taking with other medicines’ (or words to that effect).

 

3728

PAULLINIA PINNATA

A, H

 

3729

PAWPAW

E

 

3730

PEA

E

 

3731

PEA STARCH

E

 

3732

PEACH

E

 

3733

PEANUT

E

 

3734

PEAR

E

 

3735

PECAN

E

 

3736

PECTIN

A, E

 

3737

PEG-10 DIMETICONE

E

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

The concentration in the medicine must be no more than 4.0%.

 

3738

PEG-10 SOYA STEROL

E

Only for use in topical medicines for dermal application.

 

3739

PEG-100 STEARATE

E

Only for use in topical medicines for dermal application.

 

3740

PEG-12 DILAURATE

E

 

3741

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%.

 

3742

PEG-120 METHYL GLUCOSE DIOLEATE

E

Only for use in topical medicines for dermal application.

 

3743

PEG-120 STEARATE

E

Only for use in topical medicines for dermal application.

 

3744

PEG-15 COCAMINE

E

Only for use in topical medicines for dermal application.

 

3745

PEG-150 DISTEARATE

E

Only for use in topical medicines for dermal application.

 

3746

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%.

 

3747

PEG-20 METHYL GLUCOSE DISTEARATE

E

Only for use in topical medicines for dermal application.

 

3748

PEG-20 METHYL GLUCOSE SESQUISTEARATE

E

Only for use in topical medicines for dermal application.

 

3749

PEG-20 SORBITAN ISOSTEARATE

E

Only for use in topical medicines for dermal application.

 

3750

PEG-20 STEARATE

E

Only for use in topical medicines for dermal application.

 

3751

PEG-25 PABA

A

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

The concentration in the medicine must not be more than 10%.

When used in primary sunscreen products, the following warning statements are required on the label:

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

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

 

3752

PEG-30 DIPOLYHYDROXYSTEARATE

E

Only for use in topical medicines for dermal application.

 

3753

PEG-30 STEARATE

E

Only for use in topical medicines for dermal application.

 

3754

PEG-35 CASTOR OIL

E

 

3755

PEG-4 DILAURATE

E

Only for use in topical medicines for dermal application.

 

3756

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%.

 

3757

PEG-4 STEARATE

E

Only for use in topical medicines for dermal application.

 

3758

PEG-40 CASTOR OIL

E

 

3759

PEG-40 HYDROGENATED CASTOR OIL

E

 

3760

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%.

 

3761

PEG-40 STEARATE

E

Only for use in topical medicines for dermal application.

 

3762

PEG-45/DODECYL GLYCOL COPOLYMER

E

Only for use in topical medicines for dermal application.

 

3763

PEG-5 GLYCERYL STEARATE

E

Only for use in topical medicines for dermal application.

 

3764

PEG-50 STEARATE

E

Only for use in topical medicines for dermal application.

 

3765

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%.

 

3766

PEG-6 LAURAMIDE

E

Only for use in topical medicines for dermal application.

 

3767

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%.

 

3768

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%.

 

3769

PEG-60 HYDROGENATED CASTOR OIL

E

Only for use in topical medicines for dermal application.

 

3770

PEG-7 COCAMIDE

E

Only for use in topical medicines for dermal application.

 

3771

PEG-7 GLYCERYL COCOATE

E

Only for use in topical medicines for dermal application.

 

3772

PEG-7 HYDROGENATED CASTOR OIL

E

Only for use in topical medicines for dermal application.

 

3773

PEG-75 LANOLIN

E

Only for use in topical medicines for dermal application.

 

3774

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%.

 

3775

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%.

 

3776

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%.

 

3777

PEG-8 DISTEARATE

E

Only for use in topical medicines for dermal application.

 

3778

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.

 

3779

PEG-8 PROPYLENE GLYCOL COCOATE

E

 

3780

PEG-8 STEARATE

E

Only for use in topical medicines for dermal application.

 

3781

PEG-9 POLYDIMETHYLSILOXYETHYL DIMETICONE

E

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

The concentration in the medicine must be no more than 3.5%.

 

3782

PEG/PPG-14/7 DIMETHYL ETHER

E

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

The concentration in the medicine must be no more than 7%.

 

3783

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%.

 

3784

PELARGONIUM GRAVEOLENS

A, E, H

 

3785

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%.

 

3786

PELTIGERA CANINA

A, H

 

3787

PENICILLIUM EXPANSUM

A, H

 

3788

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.

 

3789

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%

 

3790

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%.

 

3791

PENTAERYTHRITYL TETRALAURATE

E

Only for use in topical medicines for dermal application.

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

 

3792

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%.

 

3793

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%.

 

3794

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%.

 

3795

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%.

 

3796

PEPPER BLACK

E, H

 

3797

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%.

 

3798

PEPPER WHITE

E, H

 

3799

PEPPERMINT AMERICAN EXT.

E

Menthol is a mandatory component of peppermint american ext.

When the medicine is for topical use for dermal application:

a) the medicine must not be intended for use in the eye or on damaged skin;

b) the medicine must not deliver more than 25% total menthol when administered according to the directions for use;

c) the following warning statement is required on the medicine label:

- (EYE) Avoid contact with eyes (or words to that effect).

d) if the medicine delivers more than 1% total menthol when administered according to the directions for use, the following warning statements are required on the medicine label:

- (SKTEST) If you have sensitive skin, test this product on a small area of skin before applying it to a large area;

- (IRRIT) If irritation develops, discontinue use.

e) if the medicine delivers more than 5% total menthol when administered according to the directions for use, the following warning statement is required on the medicine label:

– (MENTH) Contains a high concentration of menthol, which can cause severe skin irritation.

When the medicine is for internal use, the maximum recommended daily dose must not contain more than 1 gram of menthol.

 

3800

PEPPERMINT LEAF DRY

A, E, H

Menthol is a mandatory component of peppermint leaf dry.

When the medicine is for topical use for dermal application:

(i) the medicine must not be intended for use in the eye or on damaged skin;

(ii) the medicine must not deliver more than 25% total menthol when administered according to the directions for use;

(iii) the following warning statement is required on the medicine label:

- (EYE) Avoid contact with eyes (or words to that effect).

(iv) if the medicine delivers more than 1% total menthol when administered according to the directions for use, the following warning statements are required on the medicine label:

- (SKTEST) If you have sensitive skin, test this product on a small area of skin before applying it to a large area;

- (IRRIT) If irritation develops, discontinue use.

(v) if the medicine delivers more than 5% total menthol when administered according to the directions for use, the following warning statement is required on the medicine label:

– (MENTH) Contains a high concentration of menthol, which can cause severe skin irritation.

When the medicine is for internal use, the maximum recommended daily dose must not contain more than 1 gram of menthol.

 

3801

PEPPERMINT LEAF POWDER

A, E, H

Menthol is a mandatory component of peppermint leaf powder.

When the medicine is for topical use for dermal application:

(i) the medicine must not be intended for use in the eye or on damaged skin;

(ii) the medicine must not deliver more than 25% total menthol when administered according to the directions for use;

(iii) the following warning statement is required on the medicine label:

- (EYE) Avoid contact with eyes (or words to that effect).

(iv) if the medicine delivers more than 1% total menthol when administered according to the directions for use, the following warning statements are required on the medicine label:

- (SKTEST) If you have sensitive skin, test this product on a small area of skin before applying it to a large area;

- (IRRIT) If irritation develops, discontinue use.

(v) if the medicine delivers more than 5% total menthol when administered according to the directions for use, the following warning statement is required on the medicine label:

– (MENTH) Contains a high concentration of menthol, which can cause severe skin irritation.

When the medicine is for internal use, the maximum recommended daily dose must not contain more than 1 gram of menthol.

 

3802

PEPPERMINT OIL

A, E, H

Menthol is a mandatory component of peppermint oil.

When the medicine is for topical use for dermal application:

(i) the medicine must not be intended for use in the eye or on damaged skin;

(ii) the medicine must not deliver more than 25% total menthol when administered according to the directions for use;

(iii) the following warning statement is required on the medicine label:

- (EYE) Avoid contact with eyes (or words to that effect).

(iv) if the medicine delivers more than 1% total menthol when administered according to the directions for use, the following warning statements are required on the medicine label:

- (SKTEST) If you have sensitive skin, test this product on a small area of skin before applying it to a large area;

- (IRRIT) If irritation develops, discontinue use.

(v) if the medicine delivers more than 5% total menthol when administered according to the directions for use, the following warning statement is required on the medicine label:

– (MENTH) Contains a high concentration of menthol, which can cause severe skin irritation.

When the medicine is for internal use, the maximum recommended daily dose must not contain more than 1 gram of menthol.

 

3803

PEPPERMINT OIL TERPENELESS

E

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

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

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

Menthol is a mandatory component of peppermint oil terpeneless.

When the medicine is for topical use for dermal application:

i) the medicine must not be intended for use in the eye or on damaged skin;

ii) the medicine must not deliver more than 25% total menthol when administered according to the directions for use;

iii) the following warning statement is required on the medicine label:

- (EYE) Avoid contact with eyes (or words to that effect).

iv) if the medicine delivers more than 1% total menthol when administered according to the directions for use, the following warning statements are required on the medicine label:

- (SKTEST) If you have sensitive skin, test this product on a small area of skin before applying it to a large area;

- (IRRIT) If irritation develops, discontinue use.

v) if the medicine delivers more than 5% total menthol when administered according to the directions for use, the following warning statement is required on the medicine label:

– (MENTH) Contains a high concentration of menthol, which can cause severe skin irritation.

When the medicine is for internal use, the maximum recommended daily dose must not contain more than 1 gram of menthol.

 

3804

PEPPERMINT OIL TERPENES AND TERPENOIDS

E

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

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

Menthol is a mandatory component of peppermint oil terpenes and terpenoids.

When the medicine is for topical use for dermal application:

i) the medicine must not be intended for use in the eye or on damaged skin;

ii) the medicine must not deliver more than 25% total menthol when administered according to the directions for use;

iii) the following warning statement is required on the medicine label:

- (EYE) Avoid contact with eyes (or words to that effect).

iv) if the medicine delivers more than 1% total menthol when administered according to the directions for use, the following warning statements are required on the medicine label:

- (SKTEST) If you have sensitive skin, test this product on a small area of skin before applying it to a large area;

- (IRRIT) If irritation develops, discontinue use.

v) if the medicine delivers more than 5% total menthol when administered according to the directions for use, the following warning statement is required on the medicine label:

– (MENTH) Contains a high concentration of menthol, which can cause severe skin irritation.

When the medicine is for internal use, the maximum recommended daily dose must not contain more than 1 gram of menthol.

 

3805

PERFLUOROPOLYMETHYLISOPROPYL ETHER

E

Only for use in topical medicines for dermal application.

 

3806

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%.

 

3807

PERILLA FRUTESCENS

A, E, H

 

3808

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%.

 

3809

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%.

 

3810

PERMETHRIN

E

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

 

3811

PERSEA AMERICANA

A, E, H

 

3812

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%.

 

3813

PERSICARIA CHINENSIS

A, H

 

3814

PERSICARIA TINCTORIA

A, H

 

3815

PERSIMMON

E

 

3816

PERU BALSAM

A, E, H

 

3817

PERU BALSAM OIL

A, E, H

 

3818

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%

 

3819

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%.

 

3820

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%.

 

3821

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.

 

3822

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%.

 

3823

PETROSELINUM CRISPUM

A, E, H

 

3824

PEUCEDANUM PRAERUPTORUM

A, E, H

 

3825

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).

 

3826

PHALARIS ARUNDINACEA

A, H

 

3827

PHALARIS CANARIENSIS

A, H

 

3828

PHASEOLUS COCCINEUS

A, H

 

3829

PHASEOLUS VULGARIS

A, H

 

3830

PHELLINUS ROBINIAE

A, E, H

 

3831

PHELLODENDRON AMURENSE

A, E, H

 

3832

PHELLODENDRON CHINENSE

A, H

 

3833

PHENACETIN

E

Only for use in topical medicines for dermal application.

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

 

3834

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%.

 

3835

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%.

 

3836

PHENETHYL ALCOHOL

E

Permitted for use only:

a) in topical medicines for dermal application; and

b) for internal use in combination with other permitted ingredients as part of a flavour proprietary excipient formulation.

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

 

3837

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%.

 

3838

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%

 

3839

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%.

 

3840

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%.

 

3841

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%.

 

3842

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%.

 

3843

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%.

 

3844

PHENOL

E

Only for use in topical medicines for dermal application.

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

 

3845

PHENOXYACETALDEHYDE

E

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

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

 

3846

PHENOXYETHANOL

E

Only for use in topical medicines for dermal application.

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

 

3847

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%.

 

3848

PHENOXYETHYLPARABEN

E

Only for use in topical medicines for dermal application.

 

3849

PHENYL DIMETHICONE

E

Only for use in topical medicines for dermal application.

 

3850

PHENYL TRIMETHICONE

E

Only for use in topical medicines for dermal application.

 

3851

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%.

 

3852

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%.

 

3853

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%.

 

3854

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%.

 

3855

PHENYLALANINE

A, E

When the maximum recommended daily dose of the medicine provides more than 500 mg phenylalanine, the following warning statement is required on the medicine label:

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

 

3856

PHENYLBENZIMIDAZOLE SULFONIC ACID

A

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

The concentration in the medicine must not be more than 4%.

When used in primary sunscreen products, the following warning statements are required on the label:

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

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

 

3857

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%.

 

3858

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%.

 

3859

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%.

 

3860

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%.

 

3861

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%.

 

3862

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%.

 

3863

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%.

 

3864

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%.

 

3865

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%.

 

3866

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%.

 

3867

PHLEUM PRATENSE

A, H

 

3868

PHLOXINE B

E

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

 

3869

PHLOXINE B ALUMINIUM LAKE

E

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

 

3870

PHOENIX DACTYLIFERA

A, E, H

 

3871

PHOSPHATIDYL CHOLINE

E

 

3872

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%.

 

3873

PHOSPHORIC ACID

E, H

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

 

3874

PHOSPHORUS

H

Only for use as an active homoeopathic ingredient. 

 

3875

PHOTINIA SERRULATA

A, H

 

3876

PHRAGMITES AUSTRALIS

A, H

 

3877

PHYLLANTHUS AMARUS

A, H

 

3878

PHYLLANTHUS EMBLICA

A, E, H

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

 

3879

PHYLLOSTACHYS NIGRA

A, E, H

 

3880

PHYSALIS ALKEKENGI

A, H

 

3881

PHYSALIS PUBESCENS

A, H

 

3882

PHYTANTRIOL

E

Only for use in topical medicines for dermal application.

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

 

3883

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%.

 

3884

PHYTOLACCA AMERICANA

A, H

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

 

3885

PHYTOMENADIONE

A, E

 

3886

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%.

 

3887

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%.

 

3888

PICEA ABIES

A, H

 

3889

PICEA MARIANA

A, H

 

3890

PICRASMA EXCELSA

A, E, H

 

3891

PICRORRHIZA KURROA

A, E, H

 

3892

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%.

 

3893

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%.

 

3894

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%.

 

3895

PIGMENT RED 4

E

Permitted for use only as a colour for topical use.

 

3896

PIGMENT RED 53

E

Permitted for use only as a colour for topical use.

 

3897

PIGMENT RED 57

E

Permitted for use only as a colour for topical use.

 

3898

PIGMENT RED 57 ALUMINIUM LAKE

E

Permitted for use only as a colour for topical use.

 

3899

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.

 

3900

PIGMENT RED 63

E

Permitted for use only as a colour for topical use.

 

3901

PIGMENT WHITE 26

E

Permitted for use only as a colour for topical use.

 

3902

PIGMENT YELLOW 12

E

Permitted for use only as a colour for topical use.

 

3903

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%.

 

3904

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%.

 

3905

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%.

 

3906

PIMENTA FRUIT OIL

A, E, H

 

3907

PIMENTA LEAF OIL

A, E, H

 

3908

PIMENTA OFFICINALIS

A, E, H

 

3909

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'.

 

3910

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).

 

3911

PIMPINELLA SAXIFRAGA

A, E, H

 

3912

PINE NEEDLE OIL SCOTCH

A, E, H

 

3913

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%.

 

3914

PINE OIL AROMATIC

A, E, H

 

3915

PINE OIL PUMILIO

A, E, H

 

3916

PINEAPPLE

E

 

3917

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%.

 

3918

PINELLIA TERNATA

A, H

 

3919

PINUS CONTORTA

A, E, H

 

3920

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%.

 

3921

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%.

 

3922

PINUS MONTICOLA

A, E, H

 

3923

PINUS MUGO

A, E, H

 

3924

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%.

 

3925

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%.

 

3926

PINUS PONDEROSA

A, E, H

 

3927

PINUS RADIATA

A, E, H

 

3928

PINUS STROBUS

A, E, H

 

3929

PINUS SYLVESTRIS

A, E, H

 

3930

PINUS TABULIFORMIS

A, E, H

 

3931

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%.

 

3932

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%.

 

3933

PIPER CHABA

A, E, H

 

3934

PIPER CUBEBA

A, E, H

 

3935

PIPER KADSURA

A, E, H

 

3936

PIPER LONGUM

A, E, H

 

3937

PIPER METHYSTICUM

A, H

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

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

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

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

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

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

The plant part must be root or rhizome.

When for oral use, the medicine may only contain dried whole or peeled root or rhizome or aqueous dispersions or aqueous extracts of whole or peeled root or rhizome.

When for topical use on the rectum, vagina or throat, the medicine may only contain dried whole or peeled root or rhizome or aqueous dispersions or aqueous extracts of whole or peeled root or rhizome.

When the container type is tea bag the maximum quantity per tea bag must be no more than 3 grams of dried whole or peeled root or rhizomes.

 

3938

PIPER NIGRUM

A, E, H

 

3939

PIPER SARMENTOSUM

A, E, H

 

3940

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%.

 

3941

PIPERINE

E

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

The total flavour proprietary formulation in a medicine must not be more than 5% and the concentration of piperine in the medicine must not be more than 0.15%.

 

3942

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%.

 

3943

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%.

 

3944

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%.

 

3945

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).

 

3946

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.

 

3947

PISCIDIA PISCIPULA

A, E, H

 

3948

PISTACIA LENTISCUS

A, E, H

 

3949

PISUM SATIVUM

A, E, H

 

3950

PLACENTA

H

Only for use as an active homoeopathic ingredient.

 

3951

PLANTAGO AFRA

A, E, H

When a dose for children is stated and the plant part is flower, seed or pollen, the following warning statement is required on the label:

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

 

3952

PLANTAGO ARENARIA

A, H

When a dose for children is stated and the plant part is flower, seed or pollen, the following warning statement is required on the label:

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

 

3953

PLANTAGO ASIATICA

A, H

When a dose for children is stated and the plant part is flower, seed or pollen, the following warning statement is required on the label:

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

 

3954

PLANTAGO LANCEOLATA

A, E, H

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

- (CHILD5) 'Use in children under 3 years is not recommended’

When a dose for children is stated and the plant part is flower, seed or pollen, the following warning statement is required on the label:

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

 

3955

PLANTAGO MAJOR

A, E, H

When a dose for children is stated and the plant part is flower, seed or pollen, the following warning statement is required on the label:

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

 

3956

PLANTAGO OVATA

A, H

When a dose for children is stated and the plant part is flower, seed or pollen, the following warning statement is required on the label:

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

 

3957

PLANTAGO SEED DRY

A, H

When a dose for children is stated and the plant part is flower, seed or pollen, the following warning statement is required on the label:

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

 

3958

PLATANUS OCCIDENTALIS

A, E, H

 

3959

PLATANUS RACEMOSA

A, H

 

3960

PLATANUS × HISPANICA

A, H

 

3961

PLATYCODON GRANDIFLORUS

A, E, H

 

3962

PLECTRANTHUS BARBATUS

A, E, H

 

3963

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%.

 

3964

PLUM

E

 

3965

PLUMBAGO EUROPAEA

A, H

 

3966

PLUMERIA ALBA

A, E, H

 

3967

PLUMERIA RUBRA

A, E, H

 

3968

POA NEMORALIS

A, H

 

3969

POA PRATENSIS

A, H

 

3970

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%.

 

3971

POGOSTEMON CABLIN

A, E, H

 

3972

POLACRILIN

E

 

3973

POLACRILIN POTASSIUM

E

 

3974

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).

 

3975

POLIGLUSAM

A, E

The average molecular mass of poliglusam must be greater than 2 kilodaltons.

When for internal use:

(a) the maximum recommended daily dose of the medicine must not provide more than 1750 milligrams poliglusam; and

(b) the following warning statement is required on the medicine label:

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

When for internal use and the dosage form is a powdered preparation, the following warning statement is required on the medicine label:

- (DNTPOW) 'Do not take powder alone. Mix with food or fluid'.

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

 

3976

POLIGLUSAM DERIVED FROM ASPERGILLUS NIGER

A, E

When for oral use:

(a) the maximum recommended daily dose of the medicine must not provide more than 2000 mg of Poliglusam derived from Aspergillus niger;

(b) the following warning statement (or words to the same effect) is required on the medicine label:

- (CHITO) 'Poliglusam should be taken at least one hour after any other medication as it may reduce the effect of other medication.'; and

(c) if the medicine is a powdered dosage form, the following warning statement is also required on the medicine label:

- (DNTPOW) 'Do not take powder alone. Mix with food or fluid.'

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

 

3977

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.

 

3978

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).

 

3979

POLOXAMER

E

Only for use in topical medicines for dermal application.

 

3980

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%.

 

3981

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%.

 

3982

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%.

 

3983

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%.

 

3984

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%.

 

3985

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%.

 

3986

POLYACRYLIC ACID

E

 

3987

POLYAMINO SUGAR CONDENSATE

E

Only for use in topical medicines for dermal application.

 

3988

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%.

 

3989

POLYBUTADIENE

E

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

 

3990

POLYBUTENE

E

Only for use in topical medicines for dermal application.

 

3991

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%.

 

3992

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%.

 

3993

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%.

 

3994

POLYDEXTROSE

E

 

3995

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%.

 

3996

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%

 

3997

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%.

 

3998

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%.

 

3999

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%.

 

4000

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%.

 

4001

POLYETHYLENE

E

 

4002

POLYGALA CHINENSIS

A, H

 

4003

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.

 

4004

POLYGALA SIBIRICA

A, E, H

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

 

4005

POLYGALA TENUIFOLIA

A

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

 

4006

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%.

 

4007

POLYGLYCERYL-2 CAPRATE

E

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

The concentration in the medicine must not be more than 0.5%.

 

4008

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%.

 

4009

POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE

E

Only for use in topical medicines for dermal application. 

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

 

4010

POLYGLYCERYL-2 DISTEARATE

E

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

The concentration in the medicine must not be more than 3%.

 

4011

POLYGLYCERYL-2 TRIISOSTEARATE

E

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

When the concentration of polyglyceryl-2 triisostearate is greater than 3%, the medicine must not be intended for use on damaged skin.

The concentration in the medicine must not be more than 5%.

 

4012

POLYGLYCERYL-2-PEG-4 STEARATE

E

Only for use in topical medicines for dermal application.

 

4013

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%.

 

4014

POLYGLYCERYL-3 DIISOSTEARATE

E

Only for use in topical medicines for dermal application.

 

4015

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%.

 

4016

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%.

 

4017

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%.

 

4018

POLYGLYCERYL-3 POLYRICINOLEATE

E

 

4019

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%.

 

4020

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%.

 

4021

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%.

 

4022

POLYGLYCERYL-4 OLEATE

E

Only for use in topical medicines for dermal application.

 

4023

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%.

 

4024

POLYGLYCERYL-6 RICINOLEATE

E

Only for use in topical medicines for dermal application.

 

4025

POLYGONATUM MULTIFLORUM

A, H

 

4026

POLYGONATUM OFFICINALE

A, H

 

4027

POLYGONATUM SIBIRICUM

A, E, H

 

4028

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%.

 

4029

POLYGONUM BISTORTA

A, H

 

4030

POLYGONUM ODORATUM

A, H

 

4031

POLYHYDROXYSTEARIC ACID

E

Only for use in topical medicines for dermal application.

 

4032

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.

 

4033

POLYISOPRENE

E

Only for use in topical medicines for dermal application.

 

4034

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%.

 

4035

POLYMETHACRYLIC ACID

E

 

4036

POLYMETHYL METHACRYLATE

E

Only for use in topical medicines for dermal application.

 

4037

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%.

 

4038

POLYPORUS UMBELLATUS

A, H

 

4039

POLYPROPYLENE

E

Only for use in topical medicines for dermal application.

 

4040

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%.

 

4041

POLYQUATERNIUM-10

E

Only for use in topical medicines for dermal application.

 

4042

POLYQUATERNIUM-11

E

Only for use in topical medicines for dermal application.

 

4043

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%.

 

4044

POLYQUATERNIUM-24

E

Only for use in topical medicines for dermal application.

 

4045

POLYQUATERNIUM-28

E

Only for use in topical medicines for dermal application.

 

4046

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%.

 

4047

POLYQUATERNIUM-4

E

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

The concentration in the medicine must not be more than 0.4%.

 

4048

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%.

 

4049

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%.

 

4050

POLYQUATERNIUM-7

E

Only for use in topical medicines for dermal application.

 

4051

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%

 

4052

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%.

 

4053

POLYSILICONE-15

A

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

The concentration in the medicine must not be more than 10%.

When used in primary sunscreen products, the following warning statements are required on the label:

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

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

 

4054

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%.

 

4055

POLYSORBATE 20

E

 

4056

POLYSORBATE 40

E

 

4057

POLYSORBATE 60

E

 

4058

POLYSORBATE 65

E

 

4059

POLYSORBATE 80

E

 

4060

POLYSORBATE 85

E

Only for use in topical medicines for dermal application.

 

4061

POLYSTYRENE

E

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

 

4062

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%.

 

4063

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.

 

4064

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%.

 

4065

POLYVINYL ACETATE

E

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

 

4066

POLYVINYL ACETATE PHTHALATE

E

 

4067

POLYVINYL ALCOHOL

E

 

4068

POLYVINYL CHLORIDE

E

Only for use in topical medicines for dermal application.

 

4069

POMEGRANATE

E

 

4070

PONCEAU SX

E

Permitted for use only as a colour for topical use.

 

4071

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.

 

4072

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%.

 

4073

PONTEDERIA CRASSIPES

A, H

 

4074

POPPY SEED

E, H

 

4075

POPPY SEED OIL

E, H

 

4076

POPULUS ALBA

A, H

 

4077

POPULUS BALSAMIIFERA

A, E, H

 

4078

POPULUS CANDICANS

A, H

 

4079

POPULUS DELTOIDES

A, H

 

4080

POPULUS NIGRA

A, H

 

4081

POPULUS TREMULA

A, H

 

4082

POPULUS TREMULOIDES

A, H

 

4083

PORCINE

H

Only for use as an active homoeopathic ingredient. 

 

4084

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%.

 

4085

PORTULACA OLERACEA

A, E, H

 

4086

POTABLE WATER

E

 

4087

POTASSIUM ACETATE

E

 

4088

POTASSIUM ARSENITE

H

Only for use as an active homoeopathic ingredient.

 

4089

POTASSIUM ASCORBATE

A, E, H

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

 

4090

POTASSIUM ASCORBATE DIHYDRATE

A, E, H

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

 

4091

POTASSIUM ASCORBYL TOCOPHERYL PHOSPHATE

E

Only for use in topical medicines for dermal application.

 

4092

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.

 

4093

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.

 

4094

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.

 

4095

POTASSIUM BICARBONATE

E

 

4096

POTASSIUM BROMIDE

H

Only for use as an active homoeopathic ingredient. 

 

4097

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.

 

4098

POTASSIUM CETYL PHOSPHATE

E

Only for use in topical medicines for dermal application.

 

4099

POTASSIUM CHLORIDE

A, E, H

When for oral use:

(a) potassium is a mandatory component of potassium chloride;

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

- (POTAS1) 'If you have kidney disease or are taking heart or blood pressure medicines - consult your doctor or pharmacist before use. Keep out of reach of children.'; and

(c) except when the medicine is for use as oral rehydration therapy, the amount of potassium chloride per dosage unit must not be more than 550 mg.

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

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

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

(c) the following warning statements are required on the medicine label:

- (UOAD) 'Use only as directed'

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

When for dental use, the concentration of potassium chloride in the medicine must not be more than 3.75%.

 

4100

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.

 

4101

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%.

 

4102

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%.

 

4103

POTASSIUM DICHROMATE

H

Only for use as an active homoeopathic ingredient.

 

4104

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.

 

4105

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.

 

4106

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.

 

4107

POTASSIUM HYDROXYCITRATE

A, H

 

4108

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.

 

4109

POTASSIUM IODIDE

A, E, H

Iodine is a mandatory component of potassium iodide.

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

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

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

 

4110

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%.

 

4111

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%.

 

4112

POTASSIUM NITRATE

A, H

Only for dental use.

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

 

4113

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.

 

 

4114

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%.

 

4115

POTASSIUM SORBATE

E

 

4116

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%.

 

4117

POTASSIUM STEARATE

E

Only for use in topical medicines for dermal application.

 

4118

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.

 

4119

POTATO STARCH

E

 

4120

POTENTILLA ANSERINA

A, H

 

4121

POTENTILLA CHINENSIS

A, H

 

4122

POTENTILLA DISCOLOR

A, H

 

4123

POTENTILLA ERECTA

A, E, H

 

4124

POTENTILLA REPTANS

A, H

 

4125

POTERIUM OFFICINALE

A, E, H

 

4126

POTERIUM SANGUISORBA

A, H

 

4127

POVIDONE

E

 

4128

POWDERED CELLULOSE

E

 

4129

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%.

 

4130

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%.

 

4131

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%.

 

4132

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%.

 

4133

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%.

 

4134

PPG-2 LANOLIN ALCOHOL ETHER

E

Only for use in topical medicines for dermal application.

 

4135

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%.

 

4136

PPG-20 LANOLIN ALCOHOL ETHER

E

Only for use in topical medicines for dermal application.

 

4137

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%.

 

4138

PPG-20 METHYL GLUCOSE ETHER DISTEARATE

E

Only for use in topical medicines for dermal application.

 

4139

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%.

 

4140

PPG-3 MYRISTYL ETHER

E

Only for use in topical medicines for dermal application.

 

4141

PPG-5-CETETH-20

E

Only for use in topical medicines for dermal application.

 

4142

PPG-5-LAUROMACROGOL 250

E

Only for use in topical medicines for dermal application.

 

4143

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%.

 

4144

PREGELATINISED MAIZE STARCH

E

 

4145

PREGELATINISED POTATO STARCH

E

 

4146

PREGELATINISED RICE STARCH

E

 

4147

PREGELATINISED STARCH

E

 

4148

PREGELATINISED WHEAT STARCH

E

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

 

4149

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%.

 

4150

PRICKLY ASH BARK DRY

A, H

 

4151

PRICKLY ASH BARK POWDER

A, H

 

4152

PRIMULA VERIS

A, E, H

 

4153

PRIMULA VULGARIS

A, E, H

 

4154

PRINSEPIA UNIFLORA

A, H

 

4155

PROBOSCIDEA PARVIFLORA

A, H

 

4156

PROGESTERONE

H

Only for use as an active homoeopathic ingredient. 

 

4157

PROLINE

A, E

 

4158

PROPAN-1-OL

E

Only for use in:

- topical medicines for dermal application; or

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

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

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

 

4159

PROPANE

E

Only for use as an excipient propellant ingredient.

 

4160

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%.

 

4161

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%.

 

4162

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%.

 

4163

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%.

 

4164

PROPIONYLLEVOCARNITINE HYDROCHLORIDE

A, H

 

4165

PROPOLIS

A, E

Lead is a mandatory component of Propolis.

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

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

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

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

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

 

4166

PROPOLIS BALSAM

A, E

Lead is a mandatory component of Propolis balsam.

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

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

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

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

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

 

4167

PROPOLIS DRY EXTRACT

A, E

Lead is a mandatory component of Propolis dry extract.

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

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

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

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

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

 

4168

PROPOLIS LIQUID EXTRACT

A, E

Lead is a mandatory component of Propolis liquid extract.

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

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

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

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

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

 

4169

PROPOLIS RESIN

A, E

Lead is a mandatory component of propolis resin.

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

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

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

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

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

 

4170

PROPOLIS TINCTURE

A, E

Lead is a mandatory component of Propolis tincture.

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

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

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

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

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

 

4171

PROPYL ACETATE

E

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

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

 

4172

PROPYL CAPROATE

E

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

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

 

4173

PROPYL GALLATE

E

 

4174

PROPYL HYDROXYBENZOATE

E

 

4175

PROPYLENE CARBONATE

E

Only for use in topical medicines for dermal application.

 

4176

PROPYLENE GLYCOL

E

 

4177

PROPYLENE GLYCOL ALGINATE

E

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

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

 

4178

PROPYLENE GLYCOL DIBENZOATE

E

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

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

 

4179

PROPYLENE GLYCOL DIDECANOATE

E

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

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

 

4180

PROPYLENE GLYCOL DIOCTANOATE

E

Only for use in topical medicines for dermal application.

 

4181

PROPYLENE GLYCOL DIOCTANOATE/DIDECANOATE

E

Only for use in topical medicines for dermal application.

 

4182

PROPYLENE GLYCOL DIPELARGONATE

E

Only for use in topical medicines for dermal application.

 

4183

PROPYLENE GLYCOL ISOCETETH-3 ACETATE

E

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

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

 

4184

PROPYLENE GLYCOL ISOSTEARATE

E

Only for use in topical medicines for dermal application.

 

4185

PROPYLENE GLYCOL MONOLAURATE

E

Only for use in topical medicines for dermal application.

 

4186

PROPYLENE GLYCOL MONOSTEARATE

E

Only for use in topical medicines for dermal application.

 

4187

PROPYLENE GLYCOL MYRISTYL ETHER ACETATE

E

Only for use in topical medicines for dermal application.

 

4188

PROSOPIS JULIFLORA

A, H

 

4189

PROTEASE

A

Must be derived from Aspergillus oryzae or Aspergillus niger.

 

4190

PROTEIN HYDROLYSATE

E

 

4191

PRUNE JUICE

E

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

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

 

4192

PRUNE JUICE CONCENTRATE

E

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

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

 

4193

PRUNELLA VULGARIS

A, H

 

4194

PRUNUS AFRICANA

A, E, H

Amygdalin and hydrocyanic acid are mandatory components of Prunus africana.

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

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

 

4195

PRUNUS ARMENIACA

A, E, H

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

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

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

 

4196

PRUNUS AVIUM

A, E, H

Amygdalin and hydrocyanic acid are mandatory components of Prunus avium.

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

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

 

4197

PRUNUS CERASIFERA

A, E, H

Amygdalin and hydrocyanic acid are mandatory components of Prunus cerasifera.

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

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

 

4198

PRUNUS CERASUS

A, E, H

Amygdalin and hydrocyanic acid are mandatory components of Prunus cerasus.

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

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

 

4199

PRUNUS DOMESTICA

A, E, H

Amygdalin and hydrocyanic acid are mandatory components of Prunus domestica.

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

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

 

4200

PRUNUS DULCIS

A, E, H

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

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

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

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

 

4201

PRUNUS HUMILIS

A, E, H

Amygdalin and hydrocyanic acid are mandatory components of Prunus humilis.

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

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

 

4202

PRUNUS JAPONICA

A, E, H

Amygdalin and hydrocyanic acid are mandatory components of Prunus japonica.

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

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

 

4203

PRUNUS LAUROCERASUS

A, E, H

Amygdalin and hydrocyanic acid are mandatory components of Prunus laurocerasus.

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

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

 

4204

PRUNUS MUME

A, E, H

Amygdalin and hydrocyanic acid are mandatory components of Prunus mume.

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

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

 

4205

PRUNUS PERSICA

A, E, H

Amygdalin and hydrocyanic acid are mandatory components of Prunus persica.

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

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

 

4206

PRUNUS SALICINA

A, E, H

Amygdalin and hydrocyanic acid are mandatory components of Prunus salicina.

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

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

 

4207

PRUNUS SEROTINA

A, E, H

Amygdalin and hydrocyanic acid are mandatory components of Prunus serotina.

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

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

 

4208

PRUNUS SPINOSA

A, E, H

Amygdalin and hydrocyanic acid are mandatory components of Prunus spinosa.

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

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

 

4209

PRUSSIAN BLUE

E

Permitted for use only as a colour for topical use.

 

4210

PSEUDOCYDONIA SINENSIS

A, H

 

4211

PSEUDOSTELLARIA HETEROPHYLLA

A, E, H

 

4212

PSEUDOTSUGA MENZIESII

A, H

 

4213

PSEUDOWINTERA COLORATA

A, H

Only for use when the plant part is leaf.

 

4214

PSIDIUM GUAJAVA

A, E, H

 

4215

PSORINUM

H

Only for use as an active homoeopathic ingredient. 

 

4216

PSYLLIUM HUSK DRY

A, H

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

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

 

4217

PSYLLIUM HUSK POWDER

A, E, H

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

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

 

4218

PSYLLIUM SEED DRY

A, E, H

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

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

 

4219

PTELEA TRIFOLIATA

A, H

 

4220

PTEROCARPUS MARSUPIUM

A, H

 

4221

PTEROCARPUS SANTALINUS

A, E, H

 

4222

PUERARIA LOBATA

A, E, H

 

4223

PUERARIA MONTANA VAR. LOBATA

A, E, H

 

4224

PULLULAN

E

 

4225

PUMICE

E

 

4226

PUMPKIN

E

 

4227

PUMPKIN SEED

E, H

 

4228

PUMPKIN SEED OIL

E, H

 

4229

PUNICA GRANATUM

A, E, H

 

4230

PURE BEE VENOM

H

Only for use as an active homoeopathic ingredient.

 

4231

PURIFIED HONEY

A, E

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

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

 

4232

PURIFIED SILICEOUS EARTH

E, H

 

4233

PURIFIED TALC

E

 

4234

PURIFIED WATER

E

 

4235

PVM/MA COPOLYMER

E

 

4236

PVM/MA DECADIENE CROSSPOLYMER

E

Only for use in topical medicines for dermal application.

 

4237

PVP/EICOSENE COPOLYMER

E

Only for use in topical medicines for dermal application.

 

4238

PVP/HEXADECENE COPOLYMER

E

Only for use in topical medicines for dermal application.

 

4239

PYRETHRINS

E

Only for use in topical medicines for dermal application.

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

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

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

 

4240

PYRIDOXAL 5-PHOSPHATE

A, E

Pyridoxine is a mandatory component of Pyridoxal 5-phosphate.

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

The maximum recommended daily dose must provide no more than 200 mg of pyridoxine.

If the medicine contains more than 50 mg and no more than 200 mg of pyridoxine per maximum recommended daily dose the medicine requires the following warning statement on the medicine label:

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

 

4241

PYRIDOXAL 5-PHOSPHATE MONOHYDRATE

A

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

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

The maximum recommended daily dose must provide no more than 200 mg of pyridoxine.

If the medicine contains more than 50 mg and no more than 200 mg of pyridoxine per maximum recommended daily dose the medicine requires the following warning statement on the medicine label:

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

 

4242

PYRIDOXINE HYDROCHLORIDE

A, E, H

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

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

The maximum recommended daily dose must provide no more than 200 mg of pyridoxine.

If the medicine contains more than 50 mg and no more than 200 mg of pyridoxine per maximum recommended daily dose the medicine requires the following warning statement on the medicine label:

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

 

4243

PYROGLUTAMIC ACID

E

 

4244

PYROLA DECORATA

A, H

 

4245

PYROLIGNEOUS ACID

E

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

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

 

4246

PYRROSIA LINGUA

A, H

 

4247

PYRROSIA PETIOLOSA

A, H

 

4248

PYRROSIA SHEARERI

A, H

 

4249

PYRUS COMMUNIS

A, E, H

Beta-arbutin is a mandatory component of Pyrus communis.

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

When for dermal application exclusively to the face:

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

b) hydroquinone is a mandatory component; and

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

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

 

4250

PYRUS PYRIFOLIA

A, H

Beta-arbutin is a mandatory component of Pyrus pyrifolia.

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

When for dermal application exclusively to the face:

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

b) hydroquinone is a mandatory component; and

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

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

 

4251

PYRUVIC ACID

E

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

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

 

4252

QUASSIA

E

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

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

 

4253

QUASSIA AMARA

A, E, H

 

4254

QUASSIA WOOD JAMAICAN DRY

A, H

 

4255

QUASSIA WOOD JAMAICAN POWDER

A, H

 

4256

QUATERNIUM-15

E

Only for use in topical medicines for dermal application.

 

4257

QUATERNIUM-18 BENTONITE

E

Only for use in topical medicines for dermal application.

 

4258

QUATERNIUM-18 HECTORITE

E

Only for use in topical medicines for dermal application.

 

4259

QUATERNIUM-52

E

Only for use in wash-on/wash-off topical medicines for dermal application and not to be included in medicines intended for use in the eye.

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

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

 

4260

QUATERNIUM-80

E

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

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

 

4261

QUERCETIN

A

 

4262

QUERCETIN DIHYDRATE

A

 

4263

QUERCUS ACUTISSIMA

A, H

 

4264

QUERCUS ALBA

A, E, H

 

4265

QUERCUS PALUSTRIS

A, H

 

4266

QUERCUS ROBUR

A, H

 

4267

QUERCUS RUBRA

A, H

 

4268

QUERCUS VIRGINIANA

A, H

 

4269

QUILLAIA DRY

A, H

 

4270

QUILLAIA POWDER

A, E, H

 

4271

QUILLAJA SAPONARIA

A, H

 

4272

QUINCE

E

 

4273

QUININE ARSENITE

H

Only for use as an active homoeopathic ingredient.

Quinine is a mandatory component of Quinine arsenite.

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

 

4274

QUININE SULFATE DIHYDRATE

H

Only for use as an active homoeopathic ingredient. 

Quinine is a mandatory component of quinine sulfate dihydrate. 

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

 

4275

QUINOLINE YELLOW

E

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

 

4276

QUINOLINE YELLOW ALUMINIUM LAKE

E

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

 

4277

QUISQUALIS INDICA

A, H

 

4278

R-ALPHA LIPOIC ACID

A

 

4279

RACEMENTHOL

E

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

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

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

 

4280

RACEMIC CAMPHOR

E, H

Only for use as an active homoeopathic or excipient ingredient.

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

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

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

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

- (NTAKEN) 'Not to be taken'.

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

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

- (NTAKEN) 'Not to be taken'.

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

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

- (NTAKEN) 'Not to be taken'.

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

 

4281

RADISH

E

 

4282

RAISIN JUICE CONCENTRATE

E

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

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

 

4283

RANUNCULUS BULBOSUS

A, H

 

4284

RANUNCULUS FICARIA

A, H

 

4285

RANUNCULUS TERNATUS

A, H

 

4286

RAPE SEED OIL

A, E, H

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

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

 

4287

RAPHANUS SATIVUS

A, H

 

4288

RASPBERRY

E

 

4289

RASPBERRY BRANDY

E

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

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

 

4290

RASPBERRY DISTILLATE

E

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

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

 

4291

RASPBERRY ESSENCE

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%.

 

4292

RASPBERRY JUICE CONCENTRATE

E

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

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

 

4293

RAUWOLFIA SERPENTINA

A, H

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

 

4294

RAUWOLFIA SERPENTINA DRY

A, H

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

 

4295

RAUWOLFIA SERPENTINA POWDER

A, H

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

 

4296

RED 27

E

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

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

 

4297

RED 27 ALUMINIUM LAKE

E

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

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

 

4298

RED ANT

H

Only for use as an active homoeopathic ingredient.

 

4299

RED CLOVER FLOWER DRY

A, H

 

4300

RED CLOVER FLOWER POWDER

A, H

 

4301

RED CORAL

H

Only for use as an active homoeopathic ingredient.

 

4302

RED DEER

A

 

4303

RED MERCURIC IODIDE

H

Only for use as an active homoeopathic ingredient.

 

4304

RED MERCURIC OXIDE

H

Only for use as an active homoeopathic ingredient.

 

4305

RED MERCURIC SULFIDE

H

Only for use as an active homoeopathic ingredient.

 

4306

REHMANNIA GLUTINOSA

A, E, H

 

4307

REL-1-((1R,2S)-1,2,3,4,5,6,7,8-OCTAHYDRO-1,2,8,8-TETRAMETHYL-2-NAPHTHALENYL)-1-ETHANONE

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%.

 

4308

RESORCINOL

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%.

 

4309

RESORCINOL DIMETHYLETHER

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%.

 

4310

RESVERATROL

A

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

The maximum recommended daily dose of the medicine must not contain more than 150 milligrams of resveratrol.

The following warning statements are required on the medicine label:

- (RESVER) 'Resveratrol may affect the way some medicines work, including Warfarin. Consult your health professional before taking with other medicines (or words to that effect).';

- (PREGNT) ‘Not recommended for use by pregnant and lactating women’ (or words to that effect)’; and

- (CHILD2) ‘Not suitable for children’.

 

4311

RETINOL

A, E

Vitamin A is a mandatory component of retinol.

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.’

 

4312

RETINOL ACETATE

A, E

Vitamin A is a mandatory component of retinol acetate.

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.’

 

4313

RETINOL PALMITATE

A, E

Vitamin A is a mandatory component of retinol palmitate.

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.’

 

4314

REYNOUTRIA JAPONICA

A, E, H

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

 

4315

RHAMNOSE

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%.

 

4316

RHAMNUS CATHARTICA

A, H

When the route of administration is oral, Hydroxyanthracene derivatives is a mandatory component of Rhamnus cathartica.

When used in oral medicines, if the maximum recommended daily dose contains more than 10 mg of hydroxyanthracene derivatives the medicine requires the following warning statements on the medicine label:

- (CHILD3) 'Use in children under 12 years is not recommended';

- (LAX2) 'Prolonged use may cause serious bowel problems'; and

- (LAX3) 'Do not use when abdominal pain, nausea or vomiting are present, or if you develop diarrhoea. If you are pregnant or breast feeding, seek the advice of a healthcare professional before taking this product' (or words to that effect).

When promoted or marketed as a laxative, the medicine requires the following warning statement on the medicine label:

- (LAX1) 'Drink plenty of water' (or words to that effect).

When not promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label:

- (LAX5) 'This product contains [name of the herb(s) or the chemical component(s)]'; and

- (LAX4) 'This product may have laxative effect'.

When used in oral medicines, if the maximum recommended daily dose contains less than 10 mg of hydroxyanthracene derivatives and is promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label:

- (CHILD3) 'Use in children under 12 years is not recommended';

- (LAX1) 'Drink plenty of water' (or words to that effect); and

- (LAX2) 'Prolonged use may cause serious bowel problems'.

 

4317

RHAMNUS FRANGULA

A, H

Glucofrangulins calculated as glucofrangulin A is a mandatory component of Rhamnus frangula.

When used in oral medicines, if the maximum recommended daily dose contains more than 10 mg of hydroxyanthracene derivatives the medicine requires the following warning statements on the medicine label:

- (CHILD3) 'Use in children under 12 years is not recommended';

- (LAX2) 'Prolonged use may cause serious bowel problems'; and

- (LAX3) 'Do not use when abdominal pain, nausea or vomiting are present, or if you develop diarrhoea. If you are pregnant or breast feeding, seek the advice of a healthcare professional before taking this product' (or words to that effect).

When promoted or marketed as a laxative, the medicine requires the following warning statement on the medicine label:

- (LAX1) 'Drink plenty of water' (or words to that effect).

When not promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label:

- (LAX5) 'This product contains [name of the herb(s) or the chemical component(s)]'; and

- (LAX4) 'This product may have laxative effect'.

When used in oral medicines, if the maximum recommended daily dose contains less than 10 mg of hydroxyanthracene derivatives and is promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label:

- (CHILD3) 'Use in children under 12 years is not recommended';

- (LAX1) 'Drink plenty of water' (or words to that effect); and

- (LAX2) 'Prolonged use may cause serious bowel problems'.

 

4318

RHATANY ROOT DRY

A, H

 

4319

RHATANY ROOT POWDER

A, H

 

4320

RHEUM OFFICINALE

A, E, H

The plant part must not be leaf.

When the route of administration is oral, Hydroxyanthracene derivatives calculated as rhein is a mandatory component of Rheum officinale.

When used in oral medicines, if the maximum recommended daily dose contains more than 10 mg of hydroxyanthracene derivatives the medicine requires the following warning statements on the medicine label:

- (CHILD3) 'Use in children under 12 years is not recommended';

- (LAX2) 'Prolonged use may cause serious bowel problems'; and

- (LAX3) 'Do not use when abdominal pain, nausea or vomiting are present, or if you develop diarrhoea. If you are pregnant or breast feeding, seek the advice of a healthcare professional before taking this product' (or words to that effect).

When promoted or marketed as a laxative, the medicine requires the following warning statement on the medicine label:

- (LAX1) 'Drink plenty of water' (or words to that effect).

When not promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label:

- (LAX5) 'This product contains [name of the herb(s) or the chemical component(s)]'; and

- (LAX4) 'This product may have laxative effect'.

When used in oral medicines, if the maximum recommended daily dose contains less than 10 mg of hydroxyanthracene derivatives and is promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label:

- (CHILD3) 'Use in children under 12 years is not recommended';

- (LAX1) 'Drink plenty of water' (or words to that effect); and

- (LAX2) 'Prolonged use may cause serious bowel problems'.

 

4321

RHEUM PALMATUM

A, E, H

The plant part must not be leaf.

When the route of administration is oral, Hydroxyanthracene derivatives calculated as rhein is a mandatory component of Rheum palmatum.

When used in oral medicines, if the maximum recommended daily dose contains more than 10 mg of hydroxyanthracene derivatives the medicine requires the following warning statements on the medicine label:

- (CHILD3) ‘Use in children under 12 years is not recommended’;

- (LAX2) ‘Prolonged use may cause serious bowel problems’; and

- (LAX3) ‘Do not use when abdominal pain, nausea or vomiting are present, or if you develop diarrhoea. If you are pregnant or breast feeding, seek the advice of a healthcare professional before taking this product' (or words to that effect).

When promoted or marketed as a laxative, the medicine requires the following warning statement on the medicine label:

- (LAX1) ‘Drink plenty of water' (or words to that effect).

When not promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label:

- (LAX5) ‘This product contains [name of the herb(s) or the chemical component(s)]’; and

- (LAX4) ‘This product may have laxative effect’.

When used in oral medicines, if the maximum recommended daily dose contains less than 10 mg of hydroxyanthracene derivatives and is promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label:

- (CHILD3) ‘Use in children under 12 years is not recommended’;

- (LAX1) ‘Drink plenty of water' (or words to that effect); and

- (LAX2) ‘Prolonged use may cause serious bowel problems’.

 

4322

RHEUM RHAPONTICUM

A, E, H

The plant part must not be leaf.

When the route of administration is oral, Hydroxyanthracene derivatives is a mandatory component of Rheum rhaponticum.

When used in oral medicines, if the maximum recommended daily dose contains more than 10 mg of hydroxyanthracene derivatives the medicine requires the following warning statements on the medicine label:

- (CHILD3) 'Use in children under 12 years is not recommended';

- (LAX2) 'Prolonged use may cause serious bowel problems'; and

- (LAX3) 'Do not use when abdominal pain, nausea or vomiting are present, or if you develop diarrhoea. If you are pregnant or breast feeding, seek the advice of a healthcare professional before taking this product' (or words to that effect).

When promoted or marketed as a laxative, the medicine requires the following warning statement on the medicine label:

- (LAX1) 'Drink plenty of water' (or words to that effect).

When not promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label:

- (LAX5) 'This product contains [name of the herb(s) or the chemical component(s)]'; and

- (LAX4) 'This product may have laxative effect'.

When used in oral medicines, if the maximum recommended daily dose contains less than 10 mg of hydroxyanthracene derivatives and is promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label:

- (CHILD3) 'Use in children under 12 years is not recommended';

- (LAX1) 'Drink plenty of water' (or words to that effect); and

- (LAX2) 'Prolonged use may cause serious bowel problems'.

 

4323

RHEUM TANGUTICUM

A, H

The plant part must not be leaf.

When the route of administration is oral, Hydroxyanthracene derivatives calculated as rhein is a mandatory component of Rheum tanguticum.

When used in oral medicines, if the maximum recommended daily dose contains more than 10 mg of hydroxyanthracene derivatives the medicine requires the following warning statements on the medicine label:

- (CHILD3) 'Use in children under 12 years is not recommended';

- (LAX2) 'Prolonged use may cause serious bowel problems'; and

- (LAX3) 'Do not use when abdominal pain, nausea or vomiting are present, or if you develop diarrhoea. If you are pregnant or breast feeding, seek the advice of a healthcare professional before taking this product' (or words to that effect).

When promoted or marketed as a laxative, the medicine requires the following warning statement on the medicine label:

- (LAX1) 'Drink plenty of water' (or words to that effect).

When not promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label:

- (LAX5) 'This product contains [name of the herb(s) or the chemical component(s)]'; and

- (LAX4) 'This product may have laxative effect'.

When used in oral medicines, if the maximum recommended daily dose contains less than 10 mg of hydroxyanthracene derivatives and is promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label:

- (CHILD3) 'Use in children under 12 years is not recommended';

- (LAX1) 'Drink plenty of water' (or words to that effect); and

- (LAX2) 'Prolonged use may cause serious bowel problems'.

 

4324

RHODAMINE B

E

Permitted for use only as a colour for topical use.

 

4325

RHODINOL

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%.

 

4326

RHODINYL ACETATE

E

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

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

 

4327

RHODIOLA ROSEA

A

Only for use in oral medicines.

Only available for use when the plant preparation is dry root powder, dry root powder as an aqueous extract or dry root powder as a hydroethanolic extract with no more than 70% ethanol v/v.

 

4328

RHODODENDRON AUREUM

A, H

 

4329

RHODODENDRON FERRUGINEUM

A, H

Beta-arbutin is a mandatory component of Rhododendron ferrugineum.

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

When for dermal application exclusively to the face:

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

b) hydroquinone is a mandatory component; and

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

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

 

4330

RHODODENDRON GROENLANDICUM

A, H

 

4331

RHODODENDRON MOLLE

A, H

The maximum recommended daily dose of the medicine must be no more than 1mg of the dry herbal material.

 

4332

RHUBARB

E, H

When the route of administration is oral, Hydroxyanthracene derivatives is a mandatory component of Rhubarb.

When used in oral medicines, if the maximum recommended daily dose contains more than 10 mg of hydroxyanthracene derivatives the medicine requires the following warning statements on the medicine label:

- (CHILD3) 'Use in children under 12 years is not recommended';

- (LAX2) 'Prolonged use may cause serious bowel problems'; and

- (LAX3) 'Do not use when abdominal pain, nausea or vomiting are present, or if you develop diarrhoea. If you are pregnant or breast feeding, seek the advice of a healthcare professional before taking this product' (or words to that effect).

When promoted or marketed as a laxative, the medicine requires the following warning statement on the medicine label:

- (LAX1) 'Drink plenty of water' (or words to that effect).

When not promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label:

- (LAX5) 'This product contains [name of the herb(s) or the chemical component(s)]'; and

- (LAX4) 'This product may have laxative effect'.

When used in oral medicines, if the maximum recommended daily dose contains less than 10 mg of hydroxyanthracene derivatives and is promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label:

- (CHILD3) 'Use in children under 12 years is not recommended';

- (LAX1) 'Drink plenty of water' (or words to that effect); and

- (LAX2) 'Prolonged use may cause serious bowel problems'.

 

4333

RHUBARB ROOT DRY

A, H

When the route of administration is oral, Hydroxyanthracene derivatives calculated as rhein is a mandatory component of rhubarb root dry.

When used in oral medicines, if the maximum recommended daily dose contains more than 10 mg of hydroxyanthracene derivatives the medicine requires the following warning statements on the medicine label:

- (CHILD3) 'Use in children under 12 years is not recommended';

- (LAX2) 'Prolonged use may cause serious bowel problems'; and

- (LAX3) 'Do not use when abdominal pain, nausea or vomiting are present, or if you develop diarrhoea. If you are pregnant or breast feeding, seek the advice of a healthcare professional before taking this product' (or words to that effect).

When promoted or marketed as a laxative, the medicine requires the following warning statement on the medicine label:

- (LAX1) 'Drink plenty of water' (or words to that effect).

When not promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label:

- (LAX5) 'This product contains [name of the herb(s) or the chemical component(s)]'; and

- (LAX4) 'This product may have laxative effect'.

When used in oral medicines, if the maximum recommended daily dose contains less than 10 mg of hydroxyanthracene derivatives and is promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label:

- (CHILD3) 'Use in children under 12 years is not recommended';

- (LAX1) 'Drink plenty of water' (or words to that effect); and

- (LAX2) 'Prolonged use may cause serious bowel problems'.

 

4334

RHUBARB ROOT POWDER

A, H

When the route of administration is oral, Hydroxyanthracene derivatives calculated as rhein is a mandatory component of rhubarb root powder.

When used in oral medicines, if the maximum recommended daily dose contains more than 10 mg of hydroxyanthracene derivatives the medicine requires the following warning statements on the medicine label:

- (CHILD3) 'Use in children under 12 years is not recommended';

- (LAX2) 'Prolonged use may cause serious bowel problems'; and

- (LAX3) 'Do not use when abdominal pain, nausea or vomiting are present, or if you develop diarrhoea. If you are pregnant or breast feeding, seek the advice of a healthcare professional before taking this product' (or words to that effect).

When promoted or marketed as a laxative, the medicine requires the following warning statement on the medicine label:

- (LAX1) 'Drink plenty of water' (or words to that effect).

When not promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label:

- (LAX5) 'This product contains [name of the herb(s) or the chemical component(s)]'; and

- (LAX4) 'This product may have laxative effect'.

When used in oral medicines, if the maximum recommended daily dose contains less than 10 mg of hydroxyanthracene derivatives and is promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label:

- (CHILD3) 'Use in children under 12 years is not recommended';

- (LAX1) 'Drink plenty of water' (or words to that effect); and

- (LAX2) 'Prolonged use may cause serious bowel problems'.

 

4335

RHUS AROMATICA

A, E, H

 

4336

RHUS CHINENSIS

A, H

 

4337

RHUS GLABRA

A, E, H

 

4338

RHUS VENENATA

H

Only for use as an active homoeopathic ingredient.

 

4339

RIBES GROSSULARIA

A, E, H

 

4340

RIBES NIGRUM

A, E, H

 

4341

RIBOFLAVIN

A, E

 

4342

RIBOFLAVIN SODIUM PHOSPHATE

A, E

 

4343

RIBOFLAVIN TETRAACETATE

E

Only for use in topical medicines for dermal application.

 

4344

RIBOFLAVINE

A, E

 

4345

RIBOFLAVINE SODIUM PHOSPHATE

A, E

 

4346

RIBONUCLEIC ACID

E

Only for use in topical medicines for dermal application.

 

4347

RIBOSE

A

Only for use in oral medicines.

 

4348

RICE

E

 

4349

RICE BRAN

E

 

4350

RICE BRAN OIL

E

 

4351

RICE BRAN WAX

A, E, H

 

4352

RICE STARCH

E

 

4353

RICE VINEGAR

E

 

4354

RICE WINE

E

Ethanol is a mandatory component of rice wine.

 

4355

RICINOLEIC ACID

E

Only for use in topical medicines for dermal application.

 

4356

RICINUS COMMUNIS

A, H

Only for use when the plant part must be seed and the plant preparation is oil fixed.

 

4357

ROBINIA PSEUDOACACIA

A, E, H

When the herbal substance is derived from plant parts other than the leaf or flower, the maximum recommended daily dose of the medicine must be no more than 1mg of the dry herbal material.

 

4358

ROHDEA JAPONICA

A, H

The maximum recommended daily dose must be no more than the equivalent of 1mg of the dry herbal material.

 

4359

ROSA ARVENSIS

A, E, H

 

4360

ROSA CANINA

A, E, H

 

4361

ROSA CYMOSA

A, E, H

 

4362

ROSA EGLANTERIA

A, E, H

 

4363

ROSA GALLICA

A, E, H

 

4364

ROSA LAEVIGATA

A, E, H

 

4365

ROSA MULTIFLORA

A, E, H

 

4366

ROSA ROXBURGHII FRUIT 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 0.002%.

 

4367

ROSA RUGOSA

A, E, H

 

4368

ROSA VILLOSA

A, E, H

 

4369

ROSA X CENTIFOLIA

A, E, H

 

4370

ROSA X DAMASCENA

A, E, H

 

4371

ROSANA

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%.

 

4372

ROSE ABSOLUTE

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%.

 

4373

ROSE FRUIT FRESH

A, E, H

 

4374

ROSE HIP

E

 

4375

ROSE OIL

A, E, H

 

4376

ROSE OXIDE

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%.

 

4377

ROSEMARY OIL

A, E, H

Safrole is a mandatory component of Rosemary oil.

When for internal use then the concentration of safrole in the medicine must be no more than 0.1%.

When for topical use then the concentration of safrole in the medicine must be no more than 1%.

 

4378

ROSMARINUS OFFICINALIS

A, E, H

Camphor and cineole are mandatory components of Rosmarinus officinalis.

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

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

When the concentration of cineole in the preparation is more than 25%, the nominal capacity of the container must not be more than 25 millilitres.

In liquid preparations other than essential oils or distillates, when the concentration of cineole in the preparation is more than 25% and the nominal capacity of the container is more than 15 millilitres but less than or equal to 25 millilitres, the medicine must have a child resistant closure and restricted flow insert fitted on the container and include the following warning statements on the medicine label:

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

- (NTAKEN) 'Not to be taken'.

In liquid preparations other than essential oils or distillates, when the concentration of cineole in the preparation is more than 25% and the nominal capacity of the container is no more than 15 millilitres, the medicine must have a restricted flow insert fitted on the container and include the following warning statements on the medicine label:

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

- (NTAKEN) 'Not to be taken'.

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

 

4379

ROYAL JELLY

A, E

10-Hydroxy-2-decenoic acid is a mandatory component of Royal jelly.

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

- (CHILD2) 'Not suitable for children'

- (ROYJ) 'Not to be taken by asthma and allergy sufferers' in 3 mm type, prominent on front and 'This product contains royal jelly which has been reported to cause severe allergic reactions and in rare cases fatalities, especially in asthma and allergy sufferers'.

 

4380

ROYAL JELLY FRESH

A, E

10-Hydroxy-2-decenoic acid is a mandatory component of Royal jelly fresh.

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

- (CHILD2) 'Not suitable for children'

- (ROYJ) 'Not to be taken by asthma and allergy sufferers' in 3 mm type, prominent on front and 'This product contains royal jelly which has been reported to cause severe allergic reactions and in rare cases fatalities, especially in asthma and allergy sufferers'.

 

4381

ROYAL JELLY LYOPHILISED

A, E

10-Hydroxy-2-decenoic acid is a mandatory component of Royal jelly lyophilised.

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

- (CHILD2) 'Not suitable for children'

- (ROYJ) 'Not to be taken by asthma and allergy sufferers' in 3 mm type, prominent on front and 'This product contains royal jelly which has been reported to cause severe allergic reactions and in rare cases fatalities, especially in asthma and allergy sufferers'.

 

4382

RUBBER NATURAL

E

Only for use in topical medicines for dermal application.

 

4383

RUBIA CORDIFOLIA

A, H

 

4384

RUBIA TINCTORUM

A, H

 

4385

RUBUS CHINGII

A, H

 

4386

RUBUS CORCHORIFOLIUS

A, H

 

4387

RUBUS COREANUS

A, E, H

 

4388

RUBUS FRUTICOSUS

A, E, H

 

4389

RUBUS IDAEUS

A, E, H

 

4390

RUBUS OCCIDENTALIS

A, E, H

 

4391

RUBUS PARVIFOLIUS

A, H

 

4392

RUBUS ROSIFOLIUS

A, H

 

4393

RUDBECKIA HIRTA

A, H

 

4394

RUE OIL

A, H

 

4395

RUM

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%.

 

4396

RUMEX ACETOSA

A, H

 

4397

RUMEX ACETOSELLA

A, H

 

4398

RUMEX CONGLOMERATUS

A, H

 

4399

RUMEX CRISPUS

A, E, H

 

4400

RUMEX PULCHER

A, H

 

4401

RUMEX SCUTATUS

A, H

 

4402

RUSCUS ACULEATUS

A, H

 

4403

RUTA GRAVEOLENS

A, E, H

 

4404

RUTOSIDE

A, E

 

4405

RYE

E

Gluten is a mandatory component of Rye when the route of administration is other than topical and mucosal.

 

4406

RYE BRAN

E

Gluten is a mandatory component of Rye bran when the route of administration is other than topical and mucosal.

 

4407

S-ISOPROPYL 3-METHYLTHIOCROTONATE

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%.

 

4408

SABINENE HYDRATE

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%.

 

4409

SACCHARIDE ISOMERATE

E

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

The concentration in the medicine must be no more than 3.66%.

 

4410

SACCHARIN

E

 

4411

SACCHARIN SODIUM

E

 

4412

SACCHAROMYCES CEREVISIAE

A, E

When for topical use, the concentration in the medicine must be no more than 1%.

 

4413

SACCHAROMYCES CEREVISIAE (BOULARDII)

A

 

4414

SACCHAROMYCES CERVISIAE POLYSACCHARIDES

E

Only for use in topical medicines for dermal 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%.

 

4415

SACCHAROMYCES/ZINC FERMENT

E

Only for use in topical medicines for dermal application.

 

4416

SACCHARUM OFFICINARUM

A, E, H

 

4417

SAFFLOWER OIL

A, E, H

 

4418

SAFFRON

E

Permitted for use only as a colour for either topical use or with an oral route of administration.

 

4419

SAGE LEAF DRY

A, E, H

Thujone is a mandatory component of Sage leaf dry.

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

 

4420

SAGE LEAF POWDER

A, H

Thujone is a mandatory component of Sage leaf powder.

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

 

4421

SAGE OIL DALMATIAN

A

Thujone is a mandatory component of Sage oil dalmatian.

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

When the concentration of Sage oil dalmatian in the medicine is more than 10% and the nominal capacity of the container is no more than 15 mL, a restricted flow insert and child resistant closure must be  fitted on the container and 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’

 

4422

SAGE OIL SPANISH

A, E, H

 

4423

SALICORNIA EUROPAEA EXTRACT

E

Only for use in topical medicines for dermal use 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 0.002%.

 

4424

SALICYLALDEHYDE

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%.

 

4425

SALICYLIC ACID

E, H

Only for use in topical medicines for dermal application.

The concentration in the medicine must be no more than 40%.

 

4426

SALIX ALBA

A, E, H

 

4427

SALIX DAPHNOIDES

A, H

 

4428

SALIX DISCOLOR

A, H

 

4429

SALIX FRAGILIS

A, H

 

4430

SALIX NIGRA

A, H

 

4431

SALIX PURPUREA

A, H

 

4432

SALSOLA KALI

A, H

 

4433

SALVIA CHINENSIS

A, H

 

4434

SALVIA FRUTICOSA

A, H

 

4435

SALVIA HISPANICA

A, E, H

 

4436

SALVIA LAVANDULAEFOLIA

A, H

 

4437

SALVIA MILTIORRHIZA

A, H

 

4438

SALVIA OFFICINALIS

A, E, H

Thujone is a mandatory component of Salvia officinalis.

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

 

4439

SALVIA SCLAREA

A, E, H

 

4440

SAMBUCUS CANADENSIS

A, H

 

4441

SAMBUCUS EBULUS

A, H

 

4442

SAMBUCUS NIGRA

A, E, H

 

4443

SANDALWOOD OIL EAST INDIAN

A, E, H

 

4444

SANGUINARIA CANADENSIS

H

Only for use as an active homoeopathic ingredient.

The potency must be more than 4X.

 

4445

SANICULA EUROPAEA

A, H

 

4446

SANTALUM ALBUM

A, E, H

 

4447

SANTALUM SPICATUM

A, E, H

The route of administration must be topical or inhalation.

The plant preparation must be oil.

The plant part must be root or stem wood including heartwood.

 

4448

SAPINDUS MUKOROSSI

A, H

 

4449

SAPONARIA OFFICINALIS

A, H

 

4450

SAPOSHNIKOVIA DIVARICATA

A, H

 

4451

SARCOSINE

E

Only for use in topical medicines for dermal 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%.

 

4452

SARGASSUM FUSIFORME

A, H

Iodine is a mandatory component of Sargassum fusiforme.

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

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

 

4453

SARGASSUM SILIQUASTRUM

A, H

Iodine is a mandatory component of Sargassum siliquastrum.

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

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

 

4454

SASSAFRAS ALBIDUM

A, H

Safrole is a mandatory component of Sassafras albidum.

When for internal use then the concentration of safrole in the medicine must be no more than 0.1%.

When for topical use then the concentration of safrole in the medicine must be no more than 1%.

 

4455

SATUREIA HORTENSIS

A, H

 

4456

SATUREIA MONTANA

A, H

 

4457

SAUROPUS SPATULIFOLIUS

A, H

 

4458

SAURURUS CHINENSIS

A, H

 

4459

SAUSSUREA COSTUS

A, H

 

4460

SAVORY OIL SUMMER

A, H

 

4461

SAXIFRAGA GRANULATA

A, E, H

 

4462

SAXIFRAGA STOLONIFERA

E

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

The concentration in the medicine must not be more than 0.0816%.

 

4463

SCAPHIUM SCAPHIGERUM

A, H

 

4464

SCHEFFLERA HEPTAPHYLLA

A, H

 

4465

SCHINOPSIS QUEBRACHO-COLORADO

A, H

 

4466

SCHINUS MOLLE

A, H

 

4467

SCHINUS MOLLE OIL

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%.

 

4468

SCHISANDRA CHINENSIS

A, E, H

 

4469

SCHIZONEPETA TENUIFOLIA

A, E, H

 

4470

SCHOENOCAULON OFFICINALE

A, H

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

 

4471

SCLAREOL

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%.

 

4472

SCLAREOLIDE

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%.

 

4473

SCLERANTHUS ANNUUS

A, H

 

4474

SCLEROTIUM GUM

E

Only for use in topical medicines for dermal application.

 

4475

SCOPOLIA CARNIOLICA

A, H

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

 

4476

SCROPHULARIA NINGPOENSIS

A, H

 

4477

SCROPHULARIA NODOSA

A, H

 

4478

SCURRULA PARASITICA VAR. GRACILIFLORA

A, H

 

4479

SCUTELLARIA BAICALENSIS

A, E, H

 

4480

SCUTELLARIA BARBATA

A, H

 

4481

SCUTELLARIA LATERIFLORA

A, E, H

 

4482

SEA WHIP 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 0.02%.

 

4483

SEC BUTYL 3-METHYLBUT-2-ENETHIOATE

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%.

 

4484

SEC-BUTYL THIOISOVALERATE

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%.

 

4485

SECALE CEREALE

A, H

Gluten is a mandatory component of Secale cereale when the plant part is seed and the route of administration is other than topical and mucosal.

 

 

4486

SEDUM ACRE

A, H

 

4487

SELAGINELLA TAMARISCINA

A, H

 

4488

SELENICEREUS GRANDIFLORUS

A, E, H

 

4489

SELENIUM

H

Only for use as an active homoeopathic ingredient.

Oral medicines must contain no more than 150 micrograms of selenium per maximum recommended daily dose.

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

- (SELE) 'This medicine contains selenium which is toxic in high doses.

A daily dose of 150 micrograms for adults of selenium from dietary supplements should not be exceeded.'

 

4490

SELENOCYSTEINE

A

Selenium is a mandatory component of Selenocysteine for oral and sublingual use.

Oral medicines must contain no more than 150 micrograms of selenium per maximum recommended daily dose.

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

- (SELE) 'This medicine contains selenium which is toxic in high doses.

 A daily dose of 150 mcg for adults of selenium from dietary supplements should not be exceeded.'

 

4491

SELENOMETHIONINE

A

Selenium is a mandatory component of Selenomethionine for oral and sublingual use.

Oral medicines must contain no more than 150 micrograms of selenium per maximum recommended daily dose.

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

- (SELE) 'This medicine contains selenium which is toxic in high doses. A daily dose of 150 micograms for adults of selenium from dietary supplements should not be exceeded.’

 

4492

SELF-EMULSIFYING GLYCERYL MONOSTEARATE

E

 

4493

SEMECARPUS ANACARDIUM

A, H

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

 

4494

SEMOLINA

E

 

4495

SEMPERVIVUM TECTORUM

A, H

 

4496

SENEGA ROOT DRY

A, H

 

4497

SENEGA ROOT POWDER

A, H

 

4498

SENNA ALEXANDRINA

A, H

When for oral or sublingual use, Hydroxyanthracene glycosides calculated as sennoside B is a mandatory component of Senna alexandrina.

When used in oral medicines, if the maximum recommended daily dose contains more than 10 mg of hydroxyanthracene derivatives the medicine requires the following warning statements on the medicine label:

- (CHILD3) 'Use in children under 12 years is not recommended';

- (LAX2) 'Prolonged use may cause serious bowel problems'; and

- (LAX3) 'Do not use when abdominal pain, nausea or vomiting are present, or if you develop diarrhoea. If you are pregnant or breast feeding, seek the advice of a healthcare professional before taking this product' (or words to that effect).

When promoted or marketed as a laxative, the medicine requires the following warning statement on the medicine label:

- (LAX1) 'Drink plenty of water' (or words to that effect).

When not promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label:

- (LAX5) 'This product contains [name of the herb(s) or the chemical component(s)]'; and

- (LAX4) 'This product may have laxative effect'.

When used in oral medicines, if the maximum recommended daily dose contains less than 10 mg of hydroxyanthracene derivatives and is promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label:

- (CHILD3) 'Use in children under 12 years is not recommended';

- (LAX1) 'Drink plenty of water' (or words to that effect); and

- (LAX2) 'Prolonged use may cause serious bowel problems'.

 

4499

SENNA FRUIT ALEXANDRIAN DRY

A, H

When for oral or sublingual use, Hydroxyanthracene glycosides calculated as sennoside B is a mandatory component of Senna fruit alexandrian dry.

When used in oral medicines, if the maximum recommended daily dose contains more than 10 mg of hydroxyanthracene derivatives the medicine requires the following warning statements on the medicine label:

- (CHILD3) 'Use in children under 12 years is not recommended';

- (LAX2) 'Prolonged use may cause serious bowel problems'; and

- (LAX3) 'Do not use when abdominal pain, nausea or vomiting are present, or if you develop diarrhoea. If you are pregnant or breast feeding, seek the advice of a healthcare professional before taking this product' (or words to that effect).

When promoted or marketed as a laxative, the medicine requires the following warning statement on the medicine label:

- (LAX1) 'Drink plenty of water' (or words to that effect).

When not promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label:

- (LAX5) 'This product contains [name of the herb(s) or the chemical component(s)]'; and

- (LAX4) 'This product may have laxative effect'.

When used in oral medicines, if the maximum recommended daily dose contains less than 10 mg of hydroxyanthracene derivatives and is promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label:

- (CHILD3) 'Use in children under 12 years is not recommended';

- (LAX1) 'Drink plenty of water' (or words to that effect); and

- (LAX2) 'Prolonged use may cause serious bowel problems'.

 

4500

SENNA FRUIT ALEXANDRIAN POWDER

A, H

When for oral or sublingual use, Hydroxyanthracene glycosides calculated as sennoside B is a mandatory component of Senna fruit alexandrian powder.

When used in oral medicines, if the maximum recommended daily dose contains more than 10 mg of hydroxyanthracene derivatives the medicine requires the following warning statements on the medicine label:

- (CHILD3) 'Use in children under 12 years is not recommended';

- (LAX2) 'Prolonged use may cause serious bowel problems'; and

- (LAX3) 'Do not use when abdominal pain, nausea or vomiting are present, or if you develop diarrhoea. If you are pregnant or breast feeding, seek the advice of a healthcare professional before taking this product' (or words to that effect).

When promoted or marketed as a laxative, the medicine requires the following warning statement on the medicine label:

- (LAX1) 'Drink plenty of water' (or words to that effect).

When not promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label:

- (LAX5) 'This product contains [name of the herb(s) or the chemical component(s)]'; and

- (LAX4) 'This product may have laxative effect'.

When used in oral medicines, if the maximum recommended daily dose contains less than 10 mg of hydroxyanthracene derivatives and is promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label:

- (CHILD3) 'Use in children under 12 years is not recommended';

- (LAX1) 'Drink plenty of water' (or words to that effect); and

- (LAX2) 'Prolonged use may cause serious bowel problems'.

 

4501

SENNA FRUIT TINNEVELLY DRY

A, H

When for oral or sublingual use, Hydroxyanthracene glycosides calculated as sennoside B is a mandatory component of Senna fruit tinnevelly dry.

When used in oral medicines, if the maximum recommended daily dose contains more than 10 mg of hydroxyanthracene derivatives the medicine requires the following warning statements on the medicine label:

- (CHILD3) 'Use in children under 12 years is not recommended';

- (LAX2) 'Prolonged use may cause serious bowel problems'; and

- (LAX3) 'Do not use when abdominal pain, nausea or vomiting are present, or if you develop diarrhoea. If you are pregnant or breast feeding, seek the advice of a healthcare professional before taking this product' (or words to that effect).

When promoted or marketed as a laxative, the medicine requires the following warning statement on the medicine label:

- (LAX1) 'Drink plenty of water' (or words to that effect).

When not promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label:

- (LAX5) 'This product contains [name of the herb(s) or the chemical component(s)]'; and

- (LAX4) 'This product may have laxative effect'.

When used in oral medicines, if the maximum recommended daily dose contains less than 10 mg of hydroxyanthracene derivatives and is promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label:

- (CHILD3) 'Use in children under 12 years is not recommended';

- (LAX1) 'Drink plenty of water' (or words to that effect); and

- (LAX2) 'Prolonged use may cause serious bowel problems'.

 

4502

SENNA FRUIT TINNEVELLY POWDER

A, H

When for oral or sublingual, Hydroxyanthracene glycosides calculated as sennoside B is a mandatory component of Senna fruit tinnevelly powder.

When used in oral medicines, if the maximum recommended daily dose contains more than 10 mg of hydroxyanthracene derivatives the medicine requires the following warning statements on the medicine label:

- (CHILD3) 'Use in children under 12 years is not recommended';

- (LAX2) 'Prolonged use may cause serious bowel problems'; and

- (LAX3) 'Do not use when abdominal pain, nausea or vomiting are present, or if you develop diarrhoea. If you are pregnant or breast feeding, seek the advice of a healthcare professional before taking this product' (or words to that effect).

When promoted or marketed as a laxative, the medicine requires the following warning statement on the medicine label:

- (LAX1) 'Drink plenty of water' (or words to that effect).

When not promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label:

- (LAX5) 'This product contains [name of the herb(s) or the chemical component(s)]'; and

- (LAX4) 'This product may have laxative effect'.

When used in oral medicines, if the maximum recommended daily dose contains less than 10 mg of hydroxyanthracene derivatives and is promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label:

- (CHILD3) 'Use in children under 12 years is not recommended';

- (LAX1) 'Drink plenty of water' (or words to that effect); and

- (LAX2) 'Prolonged use may cause serious bowel problems'.

 

4503

SENNA LEAF DRY

A, H

When for oral or sublingual use, Hydroxyanthracene glycosides calculated as sennoside B is a mandatory component of Senna leaf dry.

When used in oral medicines, if the maximum recommended daily dose contains more than 10 mg of hydroxyanthracene derivatives the medicine requires the following warning statements on the medicine label:

- (CHILD3) 'Use in children under 12 years is not recommended';

- (LAX2) 'Prolonged use may cause serious bowel problems'; and

- (LAX3) 'Do not use when abdominal pain, nausea or vomiting are present, or if you develop diarrhoea. If you are pregnant or breast feeding, seek the advice of a healthcare professional before taking this product' (or words to that effect).

When promoted or marketed as a laxative, the medicine requires the following warning statement on the medicine label:

- (LAX1) 'Drink plenty of water' (or words to that effect).

When not promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label:

- (LAX5) 'This product contains [name of the herb(s) or the chemical component(s)]';

- (LAX4) 'This product may have laxative effect'.

When used in oral medicines, if the maximum recommended daily dose contains less than 10 mg of hydroxyanthracene derivatives and is promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label:

- (CHILD3) 'Use in children under 12 years is not recommended';

- (LAX1) 'Drink plenty of water' (or words to that effect); and

- (LAX2) 'Prolonged use may cause serious bowel problems'.

 

4504

SENNA LEAF POWDER

A, H

When for oral or sublingual use, Hydroxyanthracene glycosides calculated as sennoside B is a mandatory component of Senna Leaf Powder.

When used in oral medicines, if the maximum recommended daily dose contains more than 10 mg of hydroxyanthracene derivatives the medicine requires the following warning statements on the medicine label:

- (CHILD3) 'Use in children under 12 years is not recommended';

- (LAX2) 'Prolonged use may cause serious bowel problems'; and

- (LAX3) 'Do not use when abdominal pain, nausea or vomiting are present, or if you develop diarrhoea. If you are pregnant or breast feeding, seek the advice of a healthcare professional before taking this product' (or words to that effect).

When promoted or marketed as a laxative, the medicine requires the following warning statement on the medicine label:

- (LAX1) 'Drink plenty of water' (or words to that effect).

When not promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label:

- (LAX5) 'This product contains [name of the herb(s) or the chemical component(s)]'; and

- (LAX4) 'This product may have laxative effect'.

When used in oral medicines, if the maximum recommended daily dose contains less than 10 mg of hydroxyanthracene derivatives and is promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label:

- (CHILD3) 'Use in children under 12 years is not recommended';

- (LAX1) 'Drink plenty of water' (or words to that effect); and

- (LAX2) 'Prolonged use may cause serious bowel problems'.

 

4505

SENNA OCCIDENTALIS

A, H

Hydroxyanthracene glycosides calculated as sennoside B is a mandatory component of Senna occidentalis when the route of administration is oral administration.

When used in oral medicines, if the maximum recommended daily dose contains more than 10 mg of hydroxyanthracene derivatives the medicine requires the following warning statements on the medicine label:

- (CHILD3) 'Use in children under 12 years is not recommended';

- (LAX2) 'Prolonged use may cause serious bowel problems'; and

- (LAX3) 'Do not use when abdominal pain, nausea or vomiting are present, or if you develop diarrhoea. If you are pregnant or breast feeding, seek the advice of a healthcare professional before taking this product' [or words to that effect].

When promoted or marketed as a laxative, the medicine requires the following warning statement on the medicine label:

- (LAX1) 'Drink plenty of water' [or words to that effect].

When not promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label:

- (LAX5) 'This product contains [name of the herb(s) or the chemical component(s)]'; and

- (LAX4) 'This product may have laxative effect'.

When used in oral medicines, if the maximum recommended daily dose contains less than 10 mg of hydroxyanthracene derivatives and is promoted or marketed as laxative, the medicine the following warning statements on the medicine label:

- (CHILD3) 'Use in children under 12 years is not recommended;

- (LAX1) 'Drink plenty of water' [or words to that effect]; and

- (LAX2) 'Prolonged use may cause serious bowel problems'.

 

4506

SENNA TORA

A, H

When for oral or sublingual use, Hydroxyanthracene glycosides calculated as sennoside B is a mandatory component of Senna tora.

When used in oral medicines, if the maximum recommended daily dose contains more than 10 mg of hydroxyanthracene derivatives the medicine requires the following warning statements on the medicine label:

- (CHILD3) 'Use in children under 12 years is not recommended';

- (LAX2) 'Prolonged use may cause serious bowel problems'; and

- (LAX3) 'Do not use when abdominal pain, nausea or vomiting are present, or if you develop diarrhoea. If you are pregnant or breast feeding, seek the advice of a healthcare professional before taking this product' (or words to that effect).

When promoted or marketed as a laxative, the medicine requires the following warning statement on the medicine label:

- (LAX1) 'Drink plenty of water' (or words to that effect).

When not promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label:

- (LAX5) 'This product contains [name of the herb(s) or the chemical component(s)]'; and

- (LAX4) 'This product may have laxative effect'.

When used in oral medicines, if the maximum recommended daily dose contains less than 10 mg of hydroxyanthracene derivatives and is promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label:

- (CHILD3) 'Use in children under 12 years is not recommended';

- (LAX1) 'Drink plenty of water' (or words to that effect); and

- (LAX2) 'Prolonged use may cause serious bowel problems'.

 

4507

SEPIA

H

Only for use as an active homoeopathic ingredient. 

 

4508

SEQUOIA SEMPERVIRENS

A, H

 

4509

SEQUOIADENDRON GIGANTEUM

A, H

 

4510

SERENOA REPENS

A, H

 

4511

SERINE

A, E

 

4512

SERUM ANGUILLAE

H

Only for use as an active homoeopathic ingredient. 

 

4513

SESAME OIL

A, E, H

 

4514

SESAME SEED

E

 

4515

SESAMUM INDICUM

A, E, H

 

4516

SETARIA ITALICA

A, H

 

4517

SHARK CALCIUM CHONDROITIN SULFATE

A

 

4518

SHARK CARTILAGE

A, E

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

- (SHARK) 'Children, pregnant or breastfeeding women, and those who have recently had a heart attack, surgery or a major accident should not consume this product without medical advice' (or words to that effect)

 

4519

SHARK CHONDROITIN SULFATE

A, E

When used as an excipient:

- only for use in topical medicines for dermal application;

- not to be included in medicines intended for use in the eye; and

- the concentration in the medicine must be no more than 0.001%.

 

4520

SHARK POTASSIUM CHONDROITIN SULFATE

A

 

4521

SHARK SODIUM CHONDROITIN SULFATE

A, E

When used as an excipient:

- only for use in topical medicines for dermal application;

- not to be included in medicines intended for use in the eye; and

- the concentration in the medicine must be no more than 0.001%.

 

4522

SHARK-LIVER OIL

A, E

Vitamin A and Colecalciferol are mandatory components of Shark-liver oil.

When for internal use, the maximum recommended daily dose must be no more than 25 micrograms of Vitamin D.

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.’

 

4523

SHEA BUTTER

E

 

4524

SHEA BUTTER UNSAPONIFIABLES

E

Only for use in topical medicines for dermal application.

 

4525

SHELLAC

E

 

4526

SHEPHERD'S PURSE HERB DRY

A, H

 

4527

SHEPHERD'S PURSE HERB POWDER

A, H

 

4528

SHERRY WINE

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%.

 

4529

SIGESBECKIA ORIENTALIS

A, E, H

 

4530

SILICA

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%.

 

4531

SILICA DIMETHYL SILYLATE

E

Only for use in topical medicines for dermal 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%.

 

4532

SILICA SILYLATE

E

Only for use in topical medicines for dermal application.

 

4533

SILICIFIED MICROCRYSTALLINE CELLULOSE

E

Only for use when the route of administration is other than inhalation.

 

4534

SILICON DIOXIDE

A, E, H

Only for use when the route of administration is other than inhalation.

 

4535

SILICONE QUATERNIUM-8

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.

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

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

- (EYE) 'Avoid contact with eyes' (or words to that effect).

 

4536

SILVER

H

Only for use as an active homoeopathic ingredient. 

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

 

4537

SILVER BEET

E, H

 

4538

SILVER BOROSILICATE

E

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

The concentration in the medicine should be no more than 0.6%.  

Silver is a mandatory component of Silver borosilicate when the route of administration is topical.

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

 

4539

SILVER NITRATE

H

Only for use as an active homoeopathic ingredient. 

 

4540

SILYBUM MARIANUM

A, E, H

 

4541

SIMABA CEDRON

A, H

 

4542

SIMETHICONE

E

 

4543

SIMMONDSIA CHINENSIS

A, E, H

 

4544

SINAPIS ALBA

A, H

Allyl isothiocyanate is a mandatory component of Sinapis alba when the plant part is seed.

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

 

4545

SINAPIS ARVENSIS

A, H

 

4546

SINOMENIUM ACUTUM

A, H

 

4547

SIPHONESTEGIA CHINENSIS

A, H

 

4548

SIRAITIA GROSVENORII

A, E, H

 

4549

SISYMBRIUM OFFICINALE

A, H

 

4550

SKATOLE

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%.

 

4551

SKIPJACK-LIVER OIL

A, E

Vitamin A and Colecalciferol are mandatory components of Shark-liver oil.

When for internal use, the maximum recommended daily dose must be no more than 25 micrograms of Vitamin D.

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.’

 

4552

SLIPPERY ELM BARK DRY

A, H

 

4553

SLIPPERY ELM BARK POWDER

A, E, H

 

4554

SMILAX ARISTOLOCHIIFOLIA

A, H

 

4555

SMILAX CHINA

A, H

 

4556

SMILAX GLABRA

A, H

 

4557

SMILAX OFFICINALIS

A, E, H

 

4558

SMILAX ORNATA

A, E, H

 

4559

SMOKE EXTRACT

E

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

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

 

4560

SODIUM ACETATE

E

 

4561

SODIUM ACETYLATED HYALURONATE

E

Only for use in topical medicines for dermal 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%.

 

4562

SODIUM ACID CITRATE

A, E, H

When sodium acid citrate is used as an active ingredient, only for use in oral medicines.

 

4563

SODIUM ACRYLATES 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 0.8%.

 

4564

SODIUM ACRYLATES CROSSPOLYMER-2

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 0.7 % (w/w).

 

4565

SODIUM ACRYLOYDIMETHYLTAURATE/VP 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% (w/w).

 

4566

SODIUM ALGINATE

E

 

4567

SODIUM ASCORBATE

A, E, H

 

4568

SODIUM ASCORBYL PHOSPHATE

E

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

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

 When used in products other than sunscreens, the concentration in the medicine must be no more than 0.5%.

 

4569

SODIUM ASCORBYL/CHOLESTERYL PHOSPHATE

E

Only for use in topical medicines for dermal 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%.

 

4570

SODIUM BENZOATE

E

 

4571

SODIUM BETA-HYDROXY-BETA-METHYLBUTYRATE

A, H

 

4572

SODIUM BETA-HYDROXY-BETA-METHYLBUTYRATE MONOHYDRATE

A, H

 

4573

SODIUM BICARBONATE

A, E

When used as an active ingredient, the medicine may only be for oral rehydration salts in powdered and effervescent tablet dosage forms.

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

c) the following warning statements are required on the medicine label:

- (UOAD) 'Use only as directed.'

- (DIAR) 'If diarrhoea persists for more than 6 hours in infants under 6 months - 12 hours in children under 3 years - 24 hours in children aged 3-6 years or 48 hours in adults and children over 6 year