Aqueous Cream Bp
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Aqueous Cream BP
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Emulsifying Ointment BP 30% w/w
White soft paraffin 15% w/w
Liquid paraffin 6.0% w/w
Cetostearyl alcohol 8.1% w/w
This product contains sodium lauryl sulfate 0.9% w/w, see section 4.4. This product contains cetostearyl alcohol, 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 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
None
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).
Cetostearyl alcohol may cause local skin reactions (e.g. contact dermatitis).
4.5 Interaction with other medicinal products and other forms of interaction
None known
4.6 Fertility, pregnancy and lactation
Can be used during pregnancy and lactation
4.7 Effects on ability to drive and use machines
None known
Undesirable effects
4.8
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
4.9 Overdose
If accidentally ingested, treat smptomatically.
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
6.1 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
None known
6.3 Shelf life
Unopened 24 Months
Opened 3 Months
6.4 Special precautions for storage
Store below 25oC.
Do not freeze.
6.5 Nature and contents of container
|
Plastic jar with tight lid |
50g |
|
Plastic jar with tight lid |
100g |
|
Plastic jar with tight lid |
250g |
|
Plastic jar with tight lid |
500g |
|
Plastic jar with tight lid |
4000g |
|
Plastic tube with cap |
100g |
6.6
Special precautions for disposal and other handling
As stated on label.
7 MARKETING AUTHORISATION HOLDER
Ayrton Saunders Ltd North Way
Walworth Industrial Estate
Andover
SP10 5AZ
8 MARKETING AUTHORISATION NUMBER(S)
PL 16431/0177
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
18/02/2009
10 DATE OF REVISION OF THE TEXT
09/07/2013