SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Aqueous Cream B.P.

(Hydrous Emulsifying Ointment)

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

White Soft Paraffin B.P. 15.0% w/w Liquid Paraffin B.P. 6.0% w/w

3    PHARMACEUTICAL FORM

Cream

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

Cream

4.2    Posology and method of administration

For topical use as an emollient.

Adults, Children and the Elderly:

For the relief of minor skin irritation.

Apply sparingly to the affected area as and when required. When used as a vehicle for other active ingredients, dosage to be as indicated by the dispensing pharmacist.

Contraindications

Hypersensitivity to any of the ingredients.

4.4    Special warnings and precautions for use

For external use only.

Store out of reach of children.

4.5    Interaction with other medicinal products and other forms of interaction

None.

4.6    Fertility, pregnancy    and lactation

Can be applied during pregnancy and Lactation. However, pregnant woman are strongly advised to see their pharmacists/physicians before they use any medicinal products.

4.7    Effects on ability to    drive and use machines

None.

4.8    Undesirable effects

Hypersensitivity reactions have been reported

4.9    Overdose

Not applicable into topical usage.

If accidentally ingested in substantial quantities, apply gastric lavage.

5.1    Pharmacodynamic properties

White Soft Paraffin is bland, neutral and non-irritant to the skin, but is poorly absorbed. It is used as an emollient and protective ointment and as a basis for ointments, which are not intended to be absorbed.

Liquid Paraffin is not an irritant when applied to the mucous suifaces and is used as an emollient in irritant skin conditions.

5.2    Pharmacokinetic properties

Not applicable to a product for topical application.

5.3    Preclinical safety data

None stated.

6    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Emulsifying Wax B.P.

2-Phenoxyethanol B .P.

Purified Water B.P.

6.2    Incompatibilities

None.

6.3    Shelf life

36 months.

6.4    Special precautions for storage

Store below 25°C. Keep tightly closed. Store out of reach of children.