Aqueous Cream Bp
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Aqueous Cream B.P.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
% w/w
Active ingredient
15.0
White Soft Paraffin BP 6.0
Liquid Paraffin BP
This product contains sodium lauryl sulphate (0.9% w/w), cetostearyl alcohol and chlorocresol, see section 4.4.
For a full list of excipients, section 6.1. 3. PHARMACEUTICAL FORM Cream.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
For topical application to the skin:
As an emollient for the symptomatic relief of dry skin conditions.
4.2 Posology and method of administration
Adults, children and elderly:
To be applied to the skin as required.
4.3. Contraindications
Hypersensitivity to any of the ingredients.
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).
The package leaflet/label should include the following information:
Contains sodium lauryl sulfate and cetostearyl alcohol which may cause local skin reactions (e.g. stinging and contact dermatitis)
Contains chlorocresol which may cause allergic reactions
Keep all medicines out of the sight and reach of children.
4.5. Interactions with other medicinal products and other forms of interaction
No clinically significant drug interactions known.
4.6.
Pregnancy and lactation
The safety of aqueous cream during pregnancy and lactation has nor been established but is not considered to constitute a hazard during these periods.
4.7. Effects on ability to drive and use machines
No adverse effects known.
4.8 Undesirable effects
Occasional allergic reactions.
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
Symptoms of accidental oral ingestion may include gastrointestinal symptoms, particularly diarrhoea. Treatment need only be symptomatic.
5. PHARMACOLOGICAL PROPERTIES
5.1. Pharmacodynamic properties
White soft paraffin and liquid paraffin have emollient properties.
5.2. Pharmacokinetic properties
None applicable.
5.3. Preclinical safety data
There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Emulsifying wax (contains cetostearyl alcohol and sodium lauryl sulfate)
Chlorocresol
Purified water
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
36 months.
6.4. Special precautions for storage
Tub: Store in a cool place.
Tube: None
6.5 Nature and contents of container
Polypropylene jar with an unlined polypropylene cap.
Pack size: 500g
or Polypropylene securitub with a white pilfer-proof cap.
Pack size: 500g
or Pigmented LDPE/HDPE tube fitted with a polypropylene screw cap Pack sizes: 60g 100g
or Laminate tube fitted with a polypropylene screw cap.
Pack sizes: 60g, 100g
6.6 Special precautions for disposal
Not applicable
7 MARKETING AUTHORISATION HOLDER
The Boots Company PLC
1 Thane Road West Nottingham NG2 3AA
Trading as: BCM
8. MARKETING AUTHORISATION NUMBER
PL: 00014/5202R.
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
First Authorisation: 16th December 1986.
Renewal: 16th December 1991.
10 DATE OF REVISION OF THE TEXT
December 2014