ORAJEL MOUTH is a brand name for Benzocaine. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: For temporary relief from the pain and tenderness associated with mouth ulcers and from wearing dentures.
Verbatim from this product's MHRA label. Tap a section to expand.
Adults and children over 12 years. Directions: • Clean and dry the affected area. • Cut off tip of tube on score mark. • Apply a thin layer of Orajel Mouth Gel to the areas inside the mouth which are tender or painful. • Use up to 4 times daily, for no longer than 4 days.
• If tenderness or pain persists, consult your dentist or doctor. Not for use in children below the age of 12 years.
Not for use in children below the age of 12 years. 4 Special warnings and precautions for use 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. g. contact dermatitis. Avoid drinking hot liquids whilst using Orajel Mouth Gel. Do not use if there is a family history of methaemoglobinaemia. 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.
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 or lactation.
7 Effects on ability to drive and use machines No effect on subjects' ability to drive or operate machines. 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. uk/yellowcard.
8 Undesirable effects. Not for use in children below the age of 12 years. 4 Special warnings and precautions for use 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. g. contact dermatitis. Avoid drinking hot liquids whilst using Orajel Mouth Gel. Do not use if there is a family history of methaemoglobinaemia.
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
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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