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Topical antiseptic mouthwash Pregnancy: Section 4.6: no formal studies in man; on the basis of animal studies and, in theory, the negligible systemic absorption, it is considered highly unlikely that use during pregnancy will present a risk to the foetus. It is not known whether hexetidine is excreted in human breast milk; in view of the negligible amount that could be systemically absorbed, it is unlikely that milk concentrations will present any risk to the neonate/infant.

Hexetidine

Brand names: Oraldene

Hexetidine is a topical antiseptic used as an oromucosal rinse or spray for minor mouth and throat infections and for oral hygiene.

Adult dose

Dose: Minor mouth infections including thrush; aid in the prevention and treatment of gingivitis; management of sore throat and recurrent aphthous ulcers; alleviation of halitosis; pre- and post-dental surgery: rinse the mouth or gargle with at least 15 ml of undiluted 0.1% w/v solution.
Route: Oromucosal use - rinse the mouth or gargle; do not swallow, spit out after use
Frequency: Two to three times a day
Strength: ORALDENE contains hexetidine 0.1% w/v (SPC section 2). Shake well before use. Applies to adults and children 12 years and over (section 4.2). The mouthwash is for external use only and must not be swallowed (section 4.4). Not suitable for persistent symptoms (section 4.4). Alcohol content: 607.8 mg ethanol in each 15 ml dose (section 4.4). The SPC gives no maximum dose or duration limit.

Paediatric dose

Dose: Children 12 years and over: same as adults - rinse the mouth or gargle with at least 15 ml of undiluted 0.1% w/v solution.
Route: Oromucosal use - rinse or gargle; do not swallow, spit out after use
Frequency: Two to three times a day
SPC section 4.2: 'Children under 12 years - Not recommended.'

Dose adjustments

Renal

The SPC (section 4.2) states no renal dose adjustment.

Hepatic

The SPC (section 4.2) states no hepatic dose adjustment.

Dose independently re-sourced from UK Summary of Product Characteristics (SPC) via MHRA Products — clinician-reviewed. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

  • Hypersensitivity to the active substance or to any of the excipients (section 4.3)

Side effects

  • Generally very well tolerated with a low potential for causing irritation or sensitisation reactions (section 4.8)
  • Post-marketing adverse reactions listed in the section 4.8 table (frequency categories are in that table): hypersensitivity reactions including urticaria, angioedema, cough, dyspnoea (observed in the context of hypersensitivity), dry mouth, dysphagia, nausea, vomiting, salivary gland enlargement, dysgeusia and ageusia
  • Transient anaesthesia and application site reactions including mouth and throat mucosa irritation, oral paraesthesia, tongue or tooth discolouration, inflammation, blistering and ulceration (section 4.8)
  • Azorubine (E122) may cause allergic reactions (section 4.4)

Interactions

  • Section 4.5: 'No interactions are known.'

Monitoring

  • Not suitable for persistent symptoms - review if symptoms persist (section 4.4)

Clinical monograph

How it works

It has antibacterial and antifungal activity against organisms found in the mouth, acting on the microbial cell membrane to reduce the oral microbial load.

Prescribing in practice

  • It is for topical oromucosal use only and should not be swallowed.
  • Local irritation, altered taste, or numbness of the tongue may occur with use.
  • It provides symptomatic relief and is not a substitute for definitive treatment of significant oral or dental infection.

Monitoring

No routine laboratory monitoring is required; review if oral symptoms persist or worsen despite treatment.

Counselling the patient

  • Use as a rinse or gargle and spit it out rather than swallowing.
  • Seek dental or medical advice if mouth or throat symptoms do not improve.
  • Stop using it if you develop irritation or an unusual reaction in the mouth.

Evidence & guidelines

Use is supported by its established role as an oral antiseptic; refer to current prescribing references for indications and cautions.

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.

Pathways