Excessive absorption of benzocaine may produce methaemoglobinaemia in infants, children, and adults. The first clinical signs are cyanotic (greyish) skin discolouration (most notably on mucous membranes) and signs of unusual breathing or breathlessness.
Methaemoglobinaemia may be treated by the intravenous administration of 1% methylene blue. Treatment of overdose should be symptomatic and supportive.
3 years
Not for use in children below the age of 12 years.
Not applicable.
Macrogol 400
Polyethylene Glycol 3350S
Sodium Saccharin
Sorbic Acid
Natural Spearmint Flavour
Clove Oil
Citric acid
Dental gel
Application of benzocaine on skin and mucous membranes has resulted in hypersensitivity reactions (burning, stinging, pruritis, erythema, rash and oedema), contact dermatitis and methaemoglobinaemia in a few cases in infants, children and adults.
If symptoms persist, or are severe, or are accompanied by fever, headache, breathlessness, nausea and vomiting, consult a doctor.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
There are no additional pre-clinical data of relevance to the prescriber.
For temporary rapid relief of toothache pain associated with presence of open carious lesions and direct exposure of a vital dental pulp.
Pharmacotherapeutic group: Local anaesthetics, ATC code: N01BA05
Benzocaine is a local anaesthetic of the ester type with rapid onset, 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.
Benzocaine is absorbed through mucous membranes and damaged skin.
Anaesthetics of the ester type are hydrolysed by esterases in the plasma and, to a lesser extent, in the liver.
08 April 2015
Church & Dwight UK Limited
Premier House, Shearway Business Park
Pent Road,
Folkestone, Kent,
CT19 4RJ
United Kingdom
No special precautions for storage.
Low density polyethylene tube with external acrylate coating, medium density polypropylene cap. Tubes contain 5.3 g gel.
PL 00203/0227
Orajel® is intended for short-term use until a dentist can be consulted. Do not use continuously. Do not exceed recommended dose.
The product contains sorbic acid which may cause local skin reactions, e.g. contact dermatitis.
Avoid drinking hot liquids whilst using Orajel®.
Do not use if there is a family history of methaemoglobinaemia.
No effect on subjects' ability to drive or operate machines.
Adults and children aged 12 years and over.
Directions:
- Remove cap
- Cut off tip of tube on score mark.
- With a clean finger or swab apply an amount of gel the size of a green pea into the tooth cavity.
- Use up to 4 times daily.
- Do not use continuously. If toothache persists, consult your dentist.
Not for use in children below the age of 12 years.
21 September 2000
