TROPEX Ear drops, solution Ref.[49822] Active ingredients: Phenazone

Source: Health Products Regulatory Authority (IE)  Revision Year: 2020  Publisher: Rowa Pharmaceuticals Limited, Newtown, Bantry, Co. Cork, Ireland

Product name and form

Tropex 5% w/v Ear Drops Solution.

Pharmaceutical Form

Ear drops, solution.

Clear, colourless solution.

Qualitative and quantitative composition

Each 1 ml of solution contains Phenazone 50mg (5% w/v).

Excipient(s) with known effect: Each ml also contains 1mg methylparahydroxybenzoate.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Phenazone

Phenazone has analgesic and antipyretic properties. Topically, solutions have been used locally as ear drops in disorders such as otitis media because of its local anti-inflammatory and analgesic action.

List of Excipients

Glycerol
Methyl parahydroxybenzoate (E218)

Pack sizes and marketing

Tropex is filled into 10 ml amber glass bottles equipped with a dropper attachment consisting of a black polyethylene screw cap with a hole in the centre inserted with a red rubber teat. The rubber teat is inserted with a clear glass pipette.

Marketing authorization holder

Rowa Pharmaceuticals Limited, Newtown, Bantry, Co. Cork, Ireland

Marketing authorization dates and numbers

PA0074/002/001

Date of first authorisation: 24 March 1976
Date of last renewal: 24 March 2006

Drugs

Drug Countries
TROPEX Hong Kong, Ireland, Lithuania, Malta, Singapore

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