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 BP 30.0 %w/w

This product contains sodium lauryl sulphate 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 (Topical Semisolid)

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

Hypersensitivity to any of the ingredients.

Emulsifying ointment has been found to have major sunscreen activity in clinically normal skin. Preparations containing emulsifying ointment should not be used before phototherapy or in phototesting procedures.

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 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 (details of the other emollients were not reported; n = 100).

Aqueous cream should be applied in the direction of hair growth to reduce the risk of folliculitis.

The risk of fire should be considered when using large quantities of any paraffin-based emollient. Aqueous cream in contact with dressings and clothing is easily ignited by a naked flame. The risk is greater when this preparation is applied to large areas of the body and clothing or dressings become soaked with the emollient. Patients should be told to keep away from fire or flames and not to smoke when using this preparation.

This preparation may make skin and surfaces slippery – particular care is needed when bathing.

Aqueous cream also contains cetostearyl alcohol which may cause local skin reactions (e.g. contact dermatitis).

The package leaflet/label should include the following information:

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

Keep all medicines out of the reach of children.

Store below 25°C.

Do not freeze.

Instruct patients not to smoke or go near naked flames - risk of severe burns. Fabric (clothing, bedding, dressings etc) that has been in contact with this product burns more easily and is a serious fire hazard. Washing clothing and bedding may reduce product build-up but not totally remove it.

4.5 Interaction with other medicinal products and other forms of interaction

None known.

4.6 Pregnancy and lactation

The safety of Aqueous cream during pregnancy and lactation has not been established.

4.7 Effects on ability to drive and use machines

None known.

4.8 Undesirable effects

Immune system disorders: Occasional allergic reactions

Skin and subcutaneous tissue disorders: Emollients may exacerbate acne and/or folliculitis. When used as a leave-on emollient, aqueous cream may be associated with immediate cutaneous reactions such as stinging, burning, itching, redness and contact dermatitis (particularly in patients with eczema). See section 4.4. Rash

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 or search for MHRA Yellow Card in the Google Play or Apple App Store.

4.9 Overdose

Overdose is considered unlikely with this product when used as indicated. Symptoms of accidental oral ingestion may include gastrointestinal symptoms, particularly diarrhoea and should be treated symptomatically.

5. Pharmacological properties
5.1 Pharmacodynamic properties

The emulsifying ointment, in an aqueous mixture, produces a non-greasy cream which is used to protect skin against dirt and grease and has a detergent effect as a skin cleanser.

5.2 Pharmacokinetic properties

Not applicable.

5.3 Preclinical safety data

None stated.

6. Pharmaceutical particulars
6.1 List of excipients

Emulsifying ointment (contains emulsifying wax, liquid paraffin and white soft paraffin. Emulsifying wax itself contains cetostearyl alcohol and sodium lauryl sulfate)

Phenoxyethanol

Purified water

6.2 Incompatibilities

None known.

6.3 Shelf life

Unopened

Opened

36 months

3 months

6.4 Special precautions for storage

Store below 25°C. Do not freeze.

6.5 Nature and contents of container

Plastic jar with tight lid

Plastic jar with tight lid

Plastic jar with tight lid

Plastic jar with tight lid

Plastic jar with tight lid

Plastic tube with cap

Plastic tube with cap

50 g

100 g

250 g

500 g

4000 g

100 g

30 g

6.6 Special precautions for disposal and other handling

As stated on label.

7. Marketing authorisation holder

Pinewood Laboratories Limited

Ballymacarbry

Clonmel

Co. Tipperary

Ireland

8. Marketing authorisation number(s)

PL 04917/0057

9. Date of first authorisation/renewal of the authorisation

19 July 2004

10. Date of revision of the text

08/06/2020