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

Orajel Mouth Gel is intended for short-term use until a dentist or doctor can be consulted. Treatment with benzocaine products such as Orajel Mouth Gel may mask symptoms associated with more serious conditions and may therefore delay appropriate treatment. Do not use continuously.

Do not exceed recommended dose.

This product contains sorbic acid and propylene glycol, which may cause local skin reactions, e.g. contact dermatitis.

Avoid drinking hot liquids whilst using Orajel Mouth Gel.

Do not use if there is a family history of methaemoglobinaemia.

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

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 or lactation.

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

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.

Not applicable.