DIPROSONE Cream Ref.[27513] Active ingredients: Betamethasone

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2021  Publisher: Organon Pharma (UK) Limited, Hertford Road, Hoddesdon, Hertfordshire, EN11 9BU, UK

Product name and form

Diprosone 0.05% w/w Cream.

Pharmaceutical Form

Cream.

Qualitative and quantitative composition

Betamethasone dipropionate 0.064% w/w*

(* equivalent to 0.05% betamethasone)

Excipients with known effect:

Chlorocresol
Cetostearyl alcohol

For the full list of excipients, see section 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

Chlorocresol
Sodium dihydrogen phosphate dihydrate
Phosphoric acid
White soft paraffin
Liquid paraffin
Cetomacrogol 1000
Cetostearyl alcohol
Sodium hydroxide
Purified water

Pack sizes and marketing

5, 30 or 100 g expoxy-lined aluminium tubes with polypropylene caps.

Not all pack sizes may be marketed.

Marketing authorization holder

Organon Pharma (UK) Limited, Hertford Road, Hoddesdon, Hertfordshire, EN11 9BU, UK

Marketing authorization dates and numbers

PL 00025/0571

10 June 1986 / 20 October 2008

Drugs

Drug Countries
DIPROSONE Australia, Brazil, Canada, Germany, Estonia, France, Malta, Mexico, Netherlands, New Zealand, Singapore, United Kingdom, South Africa

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