This information is intended for use by health professionals

1. Name of the medicinal product

Aqueous Cream BP.

2. Qualitative and quantitative composition

Emulsifying ointment

30% w/w

White soft paraffin

15%w/w

Liquid paraffin

6.0%w/w

This product contains sodium lauryl sulfate 0.9%w/w, cetostearyl alcohol 8.1%w/w and phenoxyethanol 1%w/w, see section 4.4.

For full list of excipients, see section 6.1.

3. Pharmaceutical form

Cream.

4. Clinical particulars
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

Contra-indicated in patients with know hypersensitivity to phenoxyethanol.

4.4 Special warnings and precautions for use

For external use only.

Paediatric population

Aqueous cream contains sodium lauryl sulfate which may cause local skin reactions (e.g. stinging and contact dermatitits), particularly in children with atopic eczema.

An audit of children attending a paediatric dermatology clinic recorded the proportion of immediate cutaneouos 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 (details of the other emollients were not reported; n = 100).

Contains cetostearyl alcohol which may cause local skin rections (eg contact dermatitis)

Do not use this medicine if you have an allergy to phenoxyethanol or any other ingredient

4.5 Interaction with other medicinal products and other forms of interaction

None known.

4.6 Fertility, pregnancy and lactation

The product is unlikely to have any adverse effects when used as indicated.

4.7 Effects on ability to drive and use machines

None known.

4.8 Undesirable effects

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

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

4.9 Overdose

An overdose is not considered likely when used as indicated.

5. Pharmacological properties
5.1 Pharmacodynamic properties

Aqueous cream acts to hydrate the skin, and aids the penetration of active drug in the preparations in which it is used.

It is used to re-hydrate dry or chapped skin.

5.2 Pharmacokinetic properties

No information available.

5.3 Preclinical safety data

None.

6. Pharmaceutical particulars
6.1 List of excipients

Emulsifying ointment (contains emulsifying wax which itself contains cetosteryl alcohol and sodium lauryl sulfate)

Liquid paraffin

White soft paraffin

Phenoxyethanol

Purified water

6.2 Incompatibilities

No major incompatibilities are known.

6.3 Shelf life

36 months unopened

6.4 Special precautions for storage

Store below 25°C. Keep well closed. Do not allow to freeze.

6.5 Nature and contents of container

100g: White polyethylene/Aluminium/co-polymer MDPE laminated plastic tube, with polypropylene cap.

6.6 Special precautions for disposal and other handling

No Data Held

7. Marketing authorisation holder

Thornton & Ross Ltd

Huddersfield

HD7 5QH

England

8. Marketing authorisation number(s)

PL 00240/6274R

9. Date of first authorisation/renewal of the authorisation

25/03/1987 / 04/07/2001

10. Date of revision of the text

28/09/2016