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Aqueous Cream Bp

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SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Aqueous Cream BP

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Emulsifying Wax BP 9.0% w/w Nipastat (parahydroxybenzoates) 0.15% w/w

Emulsifying wax contains sodium lauryl sulfate 0.9% w/w and cetostearyl alcohol 8.1% w/w, see section 4.4.

For the full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Cream

4.1 Therapeutic indications

For the topical application to the skin:

As an emollient for the symptomatic relief of dry skin conditions. As a soap-substitute for skin washing.

4.2    Posology and method of administration

Adults, children and the elderly To be applied to the skin as required.

4.3    Contraindications

Known hypersensitivity.

4.4    Special warnings and precautions for use

The product should be kept out of the reach and sight of children and is for external use only.

Paediatric _ population

Aqueous Cream contains sodium lauryl sufate which may cause local skin reactions (eg stinging and contact dermatitis), particularly in children with atopic eczema.

An audit of children attending a paediatric dermatology clinic recorded the proportion of immediate cutaneous reactions to emollients (defined as one or more of burning, stinging, itching and redness developing within 20 minutes of application). Aqueous cream was the emollient used by most (71%), which was associated with an immediate cutaneous reaction in 56% of exposures, compared with 18% with other emollients used (detailed of the other emollients were not reported; n = 100).

Cetostearyl alcohol may cause local skin reactions (eg contact dermatitis). Hydroxybenzoates may cause allergic reactions (possibly delayed).

This package label/leaflet should include the following information:

Contains sodium lauryl sulfate which may cause local skin reactions (eg stinging and contact dermatitis).

4.5    Interaction with other medicinal products and other forms of interaction

None known.

4.6 Pregnancy and lactation

No adverse effects when used in pregnancy or lactation.

4.7 Effects on ability to drive and use machines

None known.

4.8


Undesirable effects

Very rarely hypersensitivity.

Aqueous Cream may be associated with immediate cutaneous reactions when used    as a leave-on emollient, such as stinging, burning, itching and redness.

See section 4.4.

4.9 Overdose

May lead to gastric symptoms especially diarrhoea. Treat symptomatically.

5    PHARMACOLOGICAL PROPERTIES

5.1    Pharmacodynamic properties

Emulsifying wax facilitates the preparation of oil in water emulsions which are absorbed, are non-greasy when rubbed into the skin, and protect against dirt and grease.

5.2 Pharmacokinetic properties

Plasma concentration from topical application is extremely low, therefore clinically insignificant.

5.3 Preclinical safety data

Not applicable.

6.1 List of excipients

Aqueous Cream contains emulsifying wax which itself contains cetostearyl alcohol and sodium lauryl sulfate.

White soft paraffin Liquid paraffin Phenoxyethanol

Nipastat [methyl (E218), ethyl (E214), propyl (E216), butyl hydroxybenzoates] Purified water

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

2 years.

6.4 Special precautions for storage

Do not store above 25°C.

6.5    Nature and contents of container

500g Plastic container (securitub)

100g Plastic (PVC) tube 100g Aluminium tube 30g Aluminium tube

6.6    Special precautions for disposal

Not applicable.

7    MARKETING AUTHORISATION HOLDER

Ecolab Ltd,

Lotherton Way,

Garforth, Leeds,

LS25 2JY.

8    MARKETING AUTHORISATION NUMBER(S)

PL 04509/0002

DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

10/10/2003

10


DATE OF REVISION OF THE TEXT

26/04/2013