Aqueous Cream Bp
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Aqueous Cream B.P.
(Hydrous Emulsifying Ointment)
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
White Soft Paraffin B.P. 15.0% w/w Liquid Paraffin B.P. 6.0% w/w
3 PHARMACEUTICAL FORM
Cream
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Cream
4.2 Posology and method of administration
For topical use as an emollient.
Adults, Children and the Elderly:
For the relief of minor skin irritation.
Apply sparingly to the affected area as and when required. When used as a vehicle for other active ingredients, dosage to be as indicated by the dispensing pharmacist.
Contraindications
4.3
Hypersensitivity to any of the ingredients.
4.4 Special warnings and precautions for use
For external use only.
Store out of reach of children.
4.5 Interaction with other medicinal products and other forms of interaction
None.
4.6 Fertility, pregnancy and lactation
Can be applied during pregnancy and Lactation. 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
None.
4.8 Undesirable effects
Hypersensitivity reactions have been reported
4.9 Overdose
Not applicable into topical usage.
If accidentally ingested in substantial quantities, apply gastric lavage.
5.1 Pharmacodynamic properties
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 suifaces 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
None.
6.3 Shelf life
36 months.
6.4 Special precautions for storage
Store below 25°C. Keep tightly closed. Store out of reach of children.
7
8
9
Plastic container with lid - 30g or 500g.
Special precautions for disposal None Stated.
MARKETING AUTHORISATION HOLDER
Activase Pharmaceuticals Limited,
11 Boumpoulinas,
PC. 1060 Nicosia.
Cyprus
MARKETING AUTHORISATION NUMBER(S)
PL 28444/0133
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
25th Feburary.1991 26th April 1991
DATE OF REVISION OF THE TEXT
07/10/2013