Summary of Product Characteristics (SmPC) - Aqueous cream
1 NAME OF THE MEDICINAL PRODUCT
Aqueous Cream B.P.
(Hydrous Emulsifying Ointment)
Aqueous Cream
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
White Soft Paraffin B.P. 15.0% (w/w)
Liquid Paraffin B.P. 6.0% (w/w)
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cream
Homogenous white cream. Free from foreign particles.
4.1 Therapeutic indications
Aqueous Cream is an emollient, moisturising and protective ointment for the follow-up treatment with topical steroids or in spacing such treatment. It may also be used as diluent for topical steroids. Aqueous Cream is recommended for the symptomatic treatment of red inflamed, damaged, dry or chapped skin, the protection of raw skin areas and as a pre-bathing emollient for dry/eczematous skin to alleviate drying areas.
4.2 Posology and method of administration
Posology
When used as a vehicle for other active ingredients, dosage to be as indicated by the dispensing pharmacist.
Paediatric population
The safety and efficacy of Aqueous Cream BP in children and adolescents have not been established. No data are available.
Method of administration
For cutaneous use as an emollient.
The Aqueous Cream should be thinly applied to cover the affected area completely ,massaging gently and thoroughly into the skin. Frequency of application should be established by the physician. Generally, Aqueous Cream can be used as often as required.
4.3 Contraindications
Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
4.4 Special warnings and precautions for use
Do not 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.
Use this medicine only on your skin.
Emulsifying wax contains sodium lauryl sulfate and cetostearyl alcohol, both of which may cause local skin reactions (e.g. stinging and contact dermatitis)
4.5 Interaction with other medicinal products and other forms of interaction
None stated.
4.6 Fertility, pregnancy and lactation
Aqueous Cream B.P. can be used during pregnancy and breastfeeding.
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
Not relevant.
4.8 Undesirable effects
Skin reactions including pruritus, rash, erythema, skin exfoliation, burning sensation, hypersensitivity, pain, dry skin and bullous dermatitis have been reported with product use. Should this occur the use of the product should be discontinued.
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
Not applicable into cutaneous use.
If accidentally ingested in substantial quantities, apply gastric lavage.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Emollients and Protectives - Soft paraffin and fat products, ATC code: D02AC
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 surfaces 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
Not applicable.
6.3 Shelf life
3 years
6.4 Special precautions for storage
Store below 25ºC.
Keep the container tightly closed.
6.5 Nature and contents of container
Plastic container with lid – 30g or 500g.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal
No special requirements for disposal.
7 MARKETING AUTHORISATION HOLDER
Crescent Pharma Limited
Key House
Sarum Hill, Basingstoke
RG21 8SR
United Kingdom
8 MARKETING AUTHORISATION NUMBER(S)
PL 20416/0585
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
Date of first authorisation: 25 February 1991
Date of latest renewal: 15 June 2007
10 DATE OF REVISION OF THE TEXT
09/04/2026