ORAJEL Dental gel Ref.[8440] Active ingredients: Benzocaine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2015  Publisher: Church & Dwight UK Limited, Premier House, Shearway Business Park, Pent Road, Folkestone, Kent, CT19 4RJ, United Kingdom

Product name and form

Orajel Mouth Gel.

Pharmaceutical Form

Dental gel.

Qualitative and quantitative composition

Benzocaine 10% w/w.

For full list of excipients, see Section 6.1.

Active Ingredient Description
Benzocaine

Benzocaine is a local anaesthetic of the ester type, acting to produce reversible loss of sensation by preventing or diminishing the generation and transmission of sensory nerve impulses near the site of application. Depolarisation of the neuronal membrane and ion exchange are reversibly inhibited.

List of Excipients

Chlorothymol
Eugenol
FD&C Red No. 40 (Allura Red AC): E129
Passion fruit flavour
Macrogol 400
Polyethylene glycol 3350
Propylene glycol: E1520
Purified water
Sodium saccharin: E954
Sorbic acid: E200

Pack sizes and marketing

Low density polyethylene tube with external acrylate coating, medium density polypropylene cap. Tubes contain 5.3 g.

Marketing authorization holder

Church & Dwight UK Limited, Premier House, Shearway Business Park, Pent Road, Folkestone, Kent, CT19 4RJ, United Kingdom

Marketing authorization dates and numbers

PL 00203/0229

21 September 2000

Drugs

Drug Countries
ORAJEL United Kingdom, South Africa

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