ROZEX Cream Ref.[27696] Active ingredients: Methronidazole

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2021  Publisher: Galderma (UK.) Limited, Meridien House, 69-71 Clarendon Road, Watford, Herts., WD17 1DS, UK

Product name and form

Rozex 0.75% w/w Cream.

Pharmaceutical Form

Cream.

Qualitative and quantitative composition

Metronidazole 0.75% w/w.

Excipients with known effect:

Cetostearyl alcohol (100mg/g).

One gram of cream contains 22 mg of benzyl alcohol (E1519).

For the full list of excipients, see section 6.1.

Active Ingredient Description
Methronidazole

Metronidazole is an anti-infectious drug belonging to the pharmacotherapeutic group of nitroimidazole derivatives, which have effect mainly on strict anaerobes. This effect is probably caused by interaction with DNS and different metabolites.

List of Excipients

Emulsifying wax (cetostearyl alcohol and polysorbate-60)
Benzyl alcohol (E1519)
Isopropyl palmitate
Glycerol
Sorbitol 70% (non-crystallising)
lactic acid and/or sodium hydroxide (for pH adjustment)
Purified water

Pack sizes and marketing

Aluminium tubes with epoxy phenolic lining, fitted with white polypropylene screw caps; pack sizes: 30g, 40g & 50g

Not all pack sizes may be marketed.

Marketing authorization holder

Galderma (UK.) Limited, Meridien House, 69-71 Clarendon Road, Watford, Herts., WD17 1DS, UK

Marketing authorization dates and numbers

PL 10590/0028

18th June 1997

Drugs

Drug Countries
ROZEX Austria, Brazil, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Ireland, Israel, Japan, Lithuania, Malta, Netherlands, New Zealand, Poland, Singapore, United Kingdom, South Africa

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.