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

Therapeutic indications

For temporary relief from the pain and tenderness associated with mouth ulcers and from wearing dentures.

Posology and method of administration

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.

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.

Shelf life

3 years.

Special precautions for storage

No special precautions for storage.

Nature and contents of container

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

Special precautions for disposal and other handling

Not applicable.

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