Betnovate Cream Ref.[2554] Active ingredients: Betamethasone

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2012  Publisher: Glaxo Wellcome UK Ltd., T/A GlaxoSmithKline UK, Stockley Park West, Uxbridge, Middlesex UB11 1BT

Product name and form

Betnovate Cream.

Pharmaceutical Form

Aqueous Cream.

Qualitative and quantitative composition

Betamethasone Valerate BP 0.122% W/W.

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

Chlorocresol BP
Cetomacrogol 1000 BP
Cetostearyl Alcohol BP
White Soft Paraffin BP
Liquid Paraffin BP
Sodium Acid Phosphate BP
Phosphoric Acid BP
Sodium Hydroxide BP
Purified Water BP

Pack sizes and marketing

15gm, 30gm and 100gm collapsible aluminium tubes internally coated with an epoxy resin based lacquer and closed with a cap.

500mg opaque high density polythene pots with black urea formaldehyde screw caps having a steran faced wad.

Not all pack sizes may be marketed.

Marketing authorization holder

Glaxo Wellcome UK Ltd., T/A GlaxoSmithKline UK, Stockley Park West, Uxbridge, Middlesex UB11 1BT

Marketing authorization dates and numbers

PL10949/0014

24 October 1997

Drugs

Drug Countries
BETNOVATE Albania, Austria, Australia, Brazil, Cyprus, Germany, Estonia, Spain, Hong Kong, Ireland, Israel, Lithuania, Malta, Mexico, New Zealand, Poland, Singapore, Turkey, United Kingdom, South Africa

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