4.1. Therapeutic indications

For temporary rapid relief of toothache pain associated with presence of open carious lesions and direct exposure of a vital dental pulp.

4.2. Posology and method of administration

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.

4.3. Contraindications

Known sensitivity to benzocaine or any of the other ingredients. Not to be used in those individuals suspected of lacking the normal ability to convert methaemoglobin to haemoglobin, see section 4.4 Special warnings and precautions for use and section 4.8 Undesirable effects. Not for use in children below the age of 12 years.

4.4. Special warnings and precautions for use

Orajel® Extra Strength 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® Extra Strength. Do not use if there is a family history of methaemoglobinaemia.

4.5. Interaction with other medicinal products and other forms of interaction

Benzocaine, like other derivatives of para-aminobenzoic acid, inhibits the actions of sulphonamides and therefore should not be used concomitantly with any sulphonamide.

4.6. Pregnancy and lactation

There is inadequate evidence of safety of benzocaine in human pregnancy, but it has been in wide use for many years without apparent ill consequences. No clinical data are available on the use of this product during pregnancy and lactation.

4.7. Effects on ability to drive and use machines

No effect on subjects' ability to drive or operate machines.

4.8. Undesirable effects

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.

4.9. Overdose

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.