Aqueous Cream BP (Ecolab)

1. Name Of The Medicinal Product

AQUEOUS CREAM BP

2. Qualitative And Quantitative Composition

Emulsifying Wax BP 9.0%w/w

3. Pharmaceutical Form

Cream

4. Clinical Particulars

4.1 Therapeutic Indications

As an emollient and a base for other creams. Symptomatic relief of dry skin.

4.2 Posology And Method Of Administration

Apply as required to the affected area.

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.

Hydroxybenzoates may cause allergic reactions (possibly delayed).

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.

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. Pharmaceutical Particulars

6.1 List Of Excipients

White Soft Paraffin BP

Liquid Paraffin BP

Phenoxyethanol BP

Nipastat HSE [Methyl (E218), Ethyl (E214), Propyl (E216), Butyl Hydroxybenzoates]

Purified Water BP

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 And Other Handling

Not applicable

7. Marketing Authorisation Holder

Ecolab Ltd, Lotherton Way, Garforth, Leeds, LS25 2JY.

8. Marketing Authorisation Number(S)

PL 04509/0002

9. Date Of First Authorisation/Renewal Of The Authorisation

1 May 2003

10. Date Of Revision Of The Text

November 2004 / August 2006