MOMETASONE FUROATE Cream Ref.[7528] Active ingredients: Mometasone

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Auden Mckenzie (Pharma Division) Ltd, McKenzie House, Bury Street, Ruislip, Middlesex, HA4 7TL, UK

Product name and form

Mometasone Furoate 1mg/g Cream.

Pharmaceutical Form

Cream.

White or almost white cream with no visible particles or phase separation.

Qualitative and quantitative composition

1 g of cream contains 1 mg of mometasone furoate (0.1% w/w mometasone furoate).

Excipients with known effect:

70 mg propylene glycol monopalmitostearate per gram of cream (7.0% w/w).

41.1 mg–44.7 mg stearyl alcohol per gram of cream (4.11–4.47% w/w).

For the full list of excipients, see section 6.1.

Active Ingredient Description
Mometasone

Mometasone is a topical glucocorticoid with local anti-inflammatory properties. It is likely that much of the mechanism for the effects of mometasone lies in its ability to inhibit the release of mediators of the inflammatory cascade.

List of Excipients

Hexylene glycol
Stearyl alcohol & macrogol cetostearyl ether
White beeswax
Propylene glycol monopalmitostearate
Titanium dioxide (E171)
Aluminium starch octenylsuccinate
Dilute phosphoric acid
White soft paraffin
Purified water

Pack sizes and marketing

Collapsible aluminium tubes internally coated with an epoxy resin based lacquer and closed with a polypropylene cap.

Pack sizes: 30g, 60g or 100g.

Not all pack sizes may be marketed.

Marketing authorization holder

Auden Mckenzie (Pharma Division) Ltd, McKenzie House, Bury Street, Ruislip, Middlesex, HA4 7TL, UK

Marketing authorization dates and numbers

PL 17507/0111

Date of first authorisation: 20th June 2012
Date of latest renewal: 25th May 2017

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