BETTAMOUSSE Cutaneous foam Ref.[49930] Active ingredients: Betamethasone

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2020  Publisher: RPH Pharmaceuticals AB, Box 603, 101 32 Stockholm, Sweden

Product name and form

Bettamousse 1mg/g (0.1%) cutaneous foam.

Pharmaceutical Form

Cutaneous foam.

White, foam mousse.

Qualitative and quantitative composition

1 g of foam contains 1 mg betamethasone (0.1%) as valerate.

Excipients with known effect: Cetyl Alcohol 1.10% w/w, Stearyl alcohol 0.50% w/w and Propylene glycol 2.00% w/w.

For a full list of excipients, see 6.1.

Active Ingredient Description
Betamethasone

Betamethasone is a glucocorticoid which is about eight to ten times as active as prednisolone on a weight-for-weight basis. Betamethasone has anti-inflammatory, antipruritic, and vasoconstrictive properties.

List of Excipients

Cetyl alcohol
Stearyl alcohol
Polysorbate 60
Ethanol anhydrous
Purified water
Propylene glycol
Citric acid anhydrous
Potassium citrate
Butane/Propane

Pack sizes and marketing

Pressurised container.

Aluminium EP-lined Cebal can with Precision valve and clear cover cap, with a net weight of 50 or 100g.

Not all pack sizes may be marketed.

Marketing authorization holder

RPH Pharmaceuticals AB, Box 603, 101 32 Stockholm, Sweden

Marketing authorization dates and numbers

PL 36301/0036

19 April 1996 / 19 April 2001

Drugs

Drug Countries
BETTAMOUSSE Ireland, United Kingdom

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