OTRIVIN ADULT Menthol Nasal spray, solution Ref.[50845] Active ingredients: Xylometazoline

Source: Health Products Regulatory Authority (IE)  Revision Year: 2021  Publisher: GlaxoSmithKline Consumer Healthcare (Ireland) Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

Product name and form

Otrivine Adult Menthol 0.1% w/v Nasal Spray, Solution.

Pharmaceutical Form

Nasal spray, solution (nasal spray).

Colourless to whitish, clear to opalescent nasal spray solution with an odour of menthol and eucalyptus.

Qualitative and quantitative composition

Xylometazoline Hydrochloride 0.1% w/v.

Excipients: Benzalkonium chloride 0.01% w/v.

For a full list of excipients, see section 6.1.

Active Ingredient Description
Xylometazoline

Xylometazoline acts directly on α-adrenoreceptors but does not act on β-receptors. When used topically as a nasal decongestant, xylometazoline acts rapidly and provides long-lasting relief. Onset of action is within minutes, the decongestant effect being prolonged and lasting for up to 10 hours.

List of Excipients

Benzalkonium chloride
Disodium phosphate dodecahydrate (sodium phosphate)
Disodium edetate
Sodium dihydrogen phosphate dihydrate (sodium acid phosphate)
Sodium chloride
Levomenthol (Menthol)
Cineole (Eucalyptol)
Sorbitol liquid (non-crystallising), E420
Polyoxyl Hydrogenated Castor Oil (Macrogol glycerol hydroxystearate)
Purified water

Pack sizes and marketing

Squeeze bottle of high density polyethylene and polypropylene, with polyethylene nose piece.

Pack size: 10ml.

Marketing authorization holder

GlaxoSmithKline Consumer Healthcare (Ireland) Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

Marketing authorization dates and numbers

PA0678/120/004

Date of first authorisation: 13 July 1998
Date of last renewal: 24 May 2009

Drugs

Drug Countries
OTRIVIN Austria, Canada, Cyprus, Estonia, Finland, Hong Kong, Israel, Lithuania, Malta, Nigeria, Netherlands, New Zealand, Poland, Singapore, South Africa

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