FENBID 5% w/w Gel Ref.[27889] Active ingredients: Ibuprofen

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2021  Publisher: Mercury Pharma Group Ltd., Capital House, 85 King William Street, London EC4N 7BL, UK

Product name and form

Ibuprofen 5% gel,

Fenbid gel,

Phorpain Gel,

Flexigel,

Ibuprofen Pain relief gel 5% w/w.

Pharmaceutical Form

Gel for topical application.

Clear or slightly opalescent, colourless or almost colourless gel with Isopropanol odour.

Qualitative and quantitative composition

5% w/w Ibuprofen Ph.Eur.

Excipient(s) with known effect:

Each 100mg of gel contains 1mg of Benzyl alcohol.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Ibuprofen

Ibuprofen is a propionic acid derivative NSAID that has demonstrated its efficacy by inhibition of prostaglandin synthesis. In humans ibuprofen reduces inflammatory pain, swellings and fever. Furthermore, ibuprofen reversibly inhibits platelet aggregation.

List of Excipients

Ethylhydroxycellulose EP
Sodium hydroxide EP
Benzyl alcohol EP
Isopropyl alcohol EP
Purified water EP

Pack sizes and marketing

Aluminium tube with internal epoxy phenolic coating with Polypropylene cap containing 15g (trial size/starter pack) and 30/35/50/100g of Fenbid Gel/Phorpain Gel. The 100g pack size is restricted to “Pharmacy” only. Not all pack sizes may be marketed.

Marketing authorization holder

Mercury Pharma Group Ltd., Capital House, 85 King William Street, London EC4N 7BL, UK

Marketing authorization dates and numbers

PL 10972/0045

26 April 1996

Drugs

Drug Countries
FENBID United Kingdom, South Africa

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