ETOFLAM Gel Ref.[9350] Active ingredients: Etofenamate

Source: Health Products Regulatory Authority (IE)  Revision Year: 2015  Publisher: Phoenix Labs, Suite 12, Bunkilla Plaza, Bracetown Business Park, Clonee, Co. Meath

Product name and form

Etoflam 5% w/w Gel.

Pharmaceutical Form

Gel.

A nearly transparent yellowish gel.

Qualitative and quantitative composition

The gel contains 5% w/w etofenamate.

For a full list of excipients, see section 6.1.

Active Ingredient Description
Etofenamate

Etofenamate is a flufenamic acid derivative, which is readily transported through the skin and concentrated in inflamed tissue, where it exerts anti-inflammatory and analgesic effects by inhibiting the release of histamine, lysosomal enzymes and prostaglandin.

List of Excipients

Fatty alcohol polyglycol ether
Isopropyl alcohol
Macrogol 400
Carbomer
Sodium hydroxide
Purified water

Pack sizes and marketing

Collapsible aluminium tube with an internal coating with polyethylene screw cap. Tubes contain either 20g or 100g of gel product.

Not all pack sizes may be marketed.

Marketing authorization holder

Phoenix Labs, Suite 12, Bunkilla Plaza, Bracetown Business Park, Clonee, Co. Meath

Marketing authorization dates and numbers

PA1113/002/001

Date of first authorisation: 04 April 1990
Date of last renewal: 04 February 2010

Drugs

Drug Countries
ETOFLAM Ireland

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