Aqueous Cream Bp
SUMMARY OF PRODUCT CHARACTERISTICS
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
Contraindicated in patients with known 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 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).
Contains cetostearyl alcohol which may cause local skin reactions (e.g. 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 cetostearyl 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
None.
7 MARKETING AUTHORISATION HOLDER
Thornton & Ross Ltd.
Linthwaite Laboratories
Huddersfield
HD75QH
MARKETING AUTHORISATION NUMBER(S)
PL 00240/6274R
9
10
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
25/03/1987 / 04/07/2001
DATE OF REVISION OF THE TEXT
28/09/2016