BONJELA Gel Ref.[49644] Active ingredients: Alkyldimethylbenzylammonium chloride Choline salicylate

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2020  Publisher: Reckitt Benckiser Healthcare (UK) Limited, Dansom Lane, Hull, HU8 7DS, United Kingdom

Product name and form

Bonjela.

Pharmaceutical Form

Gel.

Qualitative and quantitative composition

Active ingredient % w/w
Choline salicylate* 8.714
Cetalkonium chloride0.010

*Added as choline salicylate solution prepared from: Choline bicarbonate solution, Salicylic acid

Excipients with known effect: Ethanol 46.83 mg/dose, Fragrances containing allergens (in star anise flavour)

For the full list of excipients, see section 6.1.

Active Ingredient Description
Alkyldimethylbenzylammonium chloride
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

Alcohol (96% v/v)
Glycerol
Levomenthol
Hypromellose 4500
Star anise oil EP
Sodium saccharin
Purified water

Pack sizes and marketing

Gel is contained in an extruded aluminium membrane tube with an internal lacquer, plastic neck insert and plastic tamper-evident closure

Or

In a multi-layered plastic and aluminium tube with silver plastic tamper evident seal and plastic cap.

The 10g and 15g tubes are packed in a cardboard outer carton. The 3g tube is presented on a supporting card.

Marketing authorization holder

Reckitt Benckiser Healthcare (UK) Limited, Dansom Lane, Hull, HU8 7DS, United Kingdom

Marketing authorization dates and numbers

PL 00063/0121

21/05/2008

Drugs

Drug Countries
BONJELA Hong Kong, Ireland, Malta, Singapore, United Kingdom, South Africa
 
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