ORALDENE Mouthwash

Active ingredients: Hexetidine

Product name and form

ORALDENE.

Pharmaceutical Form

Mouthwash.

A clear red solution.

Qualitative and quantitative composition

ORALDENE contains 0.1% w/v hexetidine.

Excipients with known effect:

Ethanol (96%) 4.3 g per 100ml (4.33% w/v)

Azorubine (E122)

For the full list of excipients, see section 6.1.

Active Ingredient
Description

Hexetidine is a broad spectrum antimicrobial. It is active both in vivo and in vitro, against gram positive and negative bacterium, as well as yeasts (Candida albicans) and fungi.

List of Excipients

Polysorbate 80
Citric acid
Saccharin sodium
Levomenthol
Eucalyptus oil
Ethanol 96%
Azorubin (85%) (E122)
Sodium calcium edetate
Sodium hydroxide (E524)
Purified water

Pack sizes and marketing

ORALDENE is presented in a clear 100 ml, 200 ml and 30 ml glass bottles, with white aluminium ROPP cap or an HDPE plastic cap fitted with a polyterephthalate ethylene faced aluminium/expanded polyethylene laminated wad.

Not all pack sizes may be marketed.

Marketing authorization holder

McNeil Products Limited, 50–100 Holmers Farm Way, High Wycombe, Buckinghamshire, HP12 4EG, UK

Marketing authorization dates and numbers

PL 15513/0067

29th April 1998

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