AUDAX Ear drops, solution Ref.[49774] Active ingredients: Choline salicylate

Source: Health Products Regulatory Authority (IE)  Revision Year: 2019  Publisher: LanesHealth (Ireland) Limited, Suite 7, The Courtyard, Carmanhall Road, Sandyford, Dublin 18, Ireland

Product name and form

Audax Ear Drops Solution Choline Salicylate 20%w/v Glycerol 12.6%w/v.

Pharmaceutical Form

Ear drops solution.

Clear, faintly tan solution, with a characteristic odour.

Qualitative and quantitative composition

Choline Salicylate 20.0%w/v.

Glycerol 12.6%w/v.

Excipients: also contains 1.25%w/v ethylene oxide polyoxypropylene glycol and up to 66.6%w/v propylene glycol.

For a full list of excipients, see section 6.1.

Active Ingredient Description
Choline salicylate

Choline salicylate is an anti-inflammatory and antipyretic medication. It is often used in oral gel form for the relief of pain, discomfort, and inflammation caused by common mouth ulcers, cold sores, denture and sore spots, as well as mouth ulcers, and sore spots because of orthodontic devices.

List of Excipients

Ethylene oxide polyoxypropylene glycol
Chlorobutanol hemihydrate
Hydrochloric acid (for pH adjustment)
Propylene glycol

Pack sizes and marketing

Amber glass bottle (Ph.Eur.Type III), with a polypropylene pipette, containing 8 ml or 10 ml of product.

Marketing authorization holder

LanesHealth (Ireland) Limited, Suite 7, The Courtyard, Carmanhall Road, Sandyford, Dublin 18, Ireland

Marketing authorization dates and numbers

PA22702/003/001

Date of first authorisation: 01 April 1983
Date of last renewal: 01 April 2008

Drugs

Drug Countries
AUDAX Cyprus, Ireland, Malta

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