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BETNOVATE Lotion (2018)

Active ingredients: Betamethasone

Product Name and Form

Betnovate Lotion.

Pharmaceutical form

Lotion.

Qualitative and Quantitative Composition

Betamethasone Valerate 0.122% w/w.

Excipients with known effect: Cetostearyl alcohol.

For the full list of excipients, see section 6.1.

Chemical substance
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

Methyl Hydroxybenzoate BP
Xanthan Gum USP
Cetostearyl Alcohol BP
Liquid Paraffin BP
Isopropyl Alcohol BP
Glycerol BP
Macrogol cetostearyl ether BP
Sodium citrate BP
Citric Acid Monohydrate BP
Purified Water BP

Pack sizes and Marketing

White High Density Polyethylene (HDPE) GF4750 and Remafin white CEG 020 container with a polyethylene nozzle and a polyethylene cap.

Pack size: 20 ml; 100 ml.

Not all pack sizes may be marketed.

Marketing authorization holder
Authorization dates

Glaxo Wellcome UK Limited, T/A Glaxo Laboratories and/or GlaxoSmithKline UK, Stockley Park West, Uxbridge, Middlesex, UB11 1BT

Date of first authorisation: 1 February 1993

Date of latest renewal: 26 September 2007

Marketing authorization number:

PL 10949/0044