Skip to content
ClinCalc Pro
Menu
Calculators Drugs Pathways AI Dx Donate Get the App
Topical analgesic (oral mucosa) Pregnancy: Contraindicated in the third trimester at salicylate/acetylsalicylic acid doses greater than 100 mg/day (section 4.3). Section 4.4 advises consulting a doctor or dentist before use in the first or second trimester. Section 4.6 verbatim: 'Salicylates and Acetylsalicylic acid: low doses (up to 100 mg/day): Clinical studies indicate that doses up to 100 mg/day for restricted obstetrical use, which require specialised monitoring, appear safe. Breast feeding: Low quantities of salicylates and of their metabolites are excreted into the breast milk. Since adverse effects for the infant have not been reported up to now, short-term use of the recommended dose does not require suspending breastfeeding. Fertility: There is no information on the effects of topical oral choline salicylate and fertility.'

Choline salicylate

Brand names: Bonjela

Choline salicylate is a salicylate used topically as an oral gel for the symptomatic relief of pain from minor mouth lesions such as mouth ulcers.

Adult dose

Dose: Topical application to the oral mucosa: using a clean finger, massage approximately half an inch of the gel onto the sore area. Adults and children over the age of 16 only.
Route: Topical application to the oral mucosa (oral gel). Not for systemic/oral ingestion dosing.
Frequency: Not more than once every 3 hours
Max: Approximately half an inch of gel per application, not more than once every 3 hours - do not exceed the stated dose
UK SPC (Bonjela) section 4.2, verbatim in full: 'By topical application to the oral mucosa. Adults and children over the age of 16 : Using a clean finger massage approximately half an inch of the gel onto the sore area, not more than once every 3hours. There is no indication that dosage need be modified in the elderly. Denture irritation: Apply and leave at least 30 minutes before reinsertion of the dentures. Do not apply this product directly to the dentures.' ELDERLY: no dose modification indicated. DENTURE IRRITATION: apply and leave at least 30 minutes before reinserting dentures; do not apply the product directly to the dentures. DURATION: section 4.4 label warnings - 'Do not exceed the stated dose. Consult your doctor or dentist before use if you are in the first or second trimester of pregnancy or when symptoms persist for more than seven days.' SALICYLATE INTERACTION: 'This product contains salicylate and should not be used with acetylsalicylic acid (aspirin) or other salicylates except under the direction of a doctor.' Section 4.5: salicylates may enhance the effect of anticoagulants and inhibit the action of uricosurics. EXCIPIENTS: contains 46.83 mg of alcohol (ethanol) in each dose (equivalent to less than 2 ml beer or 1 ml of wine; may cause a burning sensation on damaged skin); less than 1 mmol sodium (23 mg) per dose, essentially sodium-free; contains fragrance with d-limonene, anisyl alcohol and linalool, which may cause allergic reactions.

Paediatric dose

NO PAEDIATRIC DOSE EXISTS - THE PRODUCT IS CONTRAINDICATED UNDER 16 YEARS, so dosePerKg is null and the weight calculator is deliberately unset. Section 4.3 verbatim: 'Not to be used in children and adolescents under the age of 16. This is because there is a possible association between salicylates and Reye's syndrome when given to children. Reye's syndrome is a very rare disease which affects the brain and liver and can be fatal.' Section 4.2 restricts the adult dose above to 'Adults and children over the age of 16'. Children over 16 therefore take the adult dose. Do not scale or extrapolate the adult dose downwards for younger children. Verify against a children's formulary.

Dose independently re-sourced from UK Summary of Product Characteristics (SPC) via the eMC; US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — clinician-reviewed. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

  • Children and adolescents under the age of 16 - possible association between salicylates and Reye's syndrome, a very rare disease affecting the brain and liver which can be fatal
  • Active peptic ulceration
  • Hypersensitivity to salicylates, acetylsalicylic acid (aspirin) or other NSAIDs, or to any of the excipients
  • Salicylates and acetylsalicylic acid at doses greater than 100 mg/day during the third trimester of pregnancy

Side effects

  • Hypersensitivity - frequency not known (section 4.8)
  • Bronchospasm and asthma - frequency not known; salicylates may precipitate bronchospasm and induce asthma attacks in susceptible patients
  • Allergic reactions to the fragrance excipients d-limonene, anisyl alcohol and linalool (section 4.4)
  • Burning sensation on damaged skin from the ethanol content (section 4.4)
  • Section 4.8 caveat: the listed effects relate to topical oral salicylates at OTC doses in short-term use; under long-term treatment of chronic conditions additional adverse effects may occur

Monitoring

  • Review if symptoms persist for more than seven days - consult a doctor or dentist
  • Do not use concurrently with aspirin or other salicylates except under the direction of a doctor
  • Caution with anticoagulants (salicylates may enhance their effect) and uricosurics (salicylates may inhibit their action)
  • Consult a doctor or dentist before use in the first or second trimester of pregnancy

Clinical monograph

How it works

Applied topically to the oral mucosa it provides local analgesic and anti-inflammatory effects through its salicylate action.

Prescribing in practice

  • Because it is a salicylate, it should not be used in children and adolescents owing to the theoretical risk of Reye's syndrome, and frequency of application should not be exceeded to avoid local irritation or salicylate effects.
  • It is intended for short-term symptomatic relief of mouth ulcers and minor oral lesions, not for prolonged use.
  • Use with caution in patients with salicylate hypersensitivity.

Monitoring

No laboratory monitoring is required; review if oral lesions persist or fail to heal so that other causes can be excluded.

Counselling the patient

  • Apply a small amount to the sore area and avoid using it more often than directed.
  • It is not suitable for children or teenagers.
  • See your dentist or doctor if a mouth ulcer lasts longer than expected.

Evidence & guidelines

Topical salicylate oral gels are an established option for symptomatic relief of minor oral lesions described in current prescribing references.

Reference: Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Related

Curated clinical cross-links plus same-class fallbacks.

Calculators
Pathways