Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Orajel Mouth Gel
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Benzocaine may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
How to take it
ORAJEL MOUTH GEL If you are unsure, you should check with your doctor, pharmacist or dentist. Avoid taking hot drinks whilst using Orajel Mouth Gel. For adults and children 12 years and over, remove cap, cut open tip of tube and with a clean finger apply an amount of gel the size of a green pea to the affected area. Do not use in children below the age of 12 years. You can use Orajel Mouth Gel up to a maximum of 4 times a day. Remember: Orajel Mouth Gel is intended for short-term use until you can get to a dentist. It should not be used continuously. Do not use for more than 4 days at a time. If the pain persists, consult your dentist. If you use more Orajel Mouth Gel than you should Contact your nearest hospital casualty department, doctor or dentist immediately.
Take this leaflet and any remaining gel with you to show the doctor or dentist.
Possible side effects
Like all medicines, Orajel Mouth Gel can cause side effects, although not everybody gets them. Stop using the gel and contact your doctor or dentist immediately if any of the following occur:
- an allergic reaction (burning, stinging, itching, redness, rash and/or swelling)
- skin irritation
- a condition called methaemoglobinaemia (difficulty converting a component of your blood called methaemoglobin to haemoglobin). If symptoms persist, or are severe, or are accompanied by fever, headache, breathlessness, nausea and vomiting, consult a doctor. Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard. By reporting side effects, you can help provide more information on the safety of this medicine.
How to store it
ORAJEL MOUTH GEL Keep this medicine out of the reach and sight of children. Do not use Orajel Mouth Gel if the tube or pack is damaged. Do not use Orajel Mouth Gel after the expiry date which is stated on the pack. 6. Further information What Orajel Mouth Gel contains Orajel Mouth Gel contains 10% w/w of benzocaine as the active ingredient. Orajel Mouth Gel also contains macrogol 400, polyethylene glycol 3350, propylene glycol, sodium saccharin (E954), chlorothymol, eugenol, passion fruit flavour, sorbic acid (E200), and FD&C Red No 40. What Orajel Mouth Gel looks like and contents of the pack Orajel Mouth Gel is a pink gel. It smells fruity. Each tube contains 5.3g of Orajel Mouth Gel. Marketing Authorisation Holder and Manufacturer The Marketing Authorisation Holder for Orajel Mouth Gel is Church & Dwight UK Ltd., Premier House, Shearway Business Park, Pent Road, Folkestone, Kent CT19 4RJ Orajel is a trademark of Church & Dwight Co., Inc. The manufacturer for Orajel Mouth Gel is Laleham Health and Beauty Limited, Mill Lane, Alton, GU34 2PR
Is this leaflet hard to see or read? Phone 0800 028 1454 for help.
The leaflet was last updated in May 2019 MA Number: 00203/0229
Frequently asked questions about Orajel Mouth Gel
How do I take Orajel Mouth Gel?
Orajel Mouth Gel comes as gel. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Orajel Mouth Gel?
The active substance in Orajel Mouth Gel is benzocaine.
Are there equivalent medicines to Orajel Mouth Gel?
Medicines with the same active substance, strength and form include: Orajel Dental Gel. They are interchangeable only if your prescriber or pharmacist says so.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Orajel Mouth Gel, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Orajel Mouth Gel without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: benzocaine
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
For temporary relief from the pain and tenderness associated with mouth ulcers and from wearing dentures.
4.2. 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.
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 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.
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 or 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.
💬 Ask about this leaflet
Ask anything about Orajel Mouth Gel. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.