Hexetidine

Pronunciation: hex-ET-ih-deen.

Generic name
hexetidine
Drug class
Topical oral antiseptic (pyrimidine derivative)
Form
Mouthwash/gargle solution, 0.1% w/v
Route
Oral rinse/gargle (topical, mouth and throat)
Legal status
Over-the-counter, where currently authorised (UK, EU); discontinued in the US, Canada, and Australia

Availability and supply rules vary by country

Trade names by country: United States · United Kingdom · Canada · Australia

Australia: Sterisol (6) · Full directory

What hexetidine is and how it works

Hexetidine is a broad-spectrum topical antiseptic used as a 0.1% mouthwash or gargle to help treat minor mouth and throat infections, gingivitis, mouth ulcers, and to support oral hygiene, including after dental surgery. (3) (4)

It has no boxed warning and is used topically (rinsed or gargled and then spat out, never swallowed). Its availability varies considerably by country: it remains an authorised product in the UK and in France/other EU markets, but has been discontinued in the United States, Canada, and Australia.

Mechanism of action: how hexetidine works

Hexetidine is a pyrimidine-derivative antiseptic with broad-spectrum activity against Gram-positive and Gram-negative bacteria, yeasts (including Candida albicans), and some fungi, through binding to proteins with electronegative sites on microbial cell surfaces; it also has mild local-anaesthetic, astringent, and deodorant properties. Antibacterial activity has been reported to persist for 10-14 hours after a single application. (3) (4)

What hexetidine is used for

Minor mouth and throat infections, including oral thrush

Used as a mouthwash/gargle to help treat minor infections of the mouth and throat, including oral thrush (candidiasis) and sore throat. (3)

Gingivitis and mouth ulcers

Used as an aid in the prevention and treatment of gingivitis (gum inflammation) and for recurrent mouth ulcers (aphthous ulcers). (3)

Oral hygiene, halitosis, and post-dental-surgery care

Used to help with general oral hygiene and to reduce bad breath (halitosis), and as an adjunctive local treatment before and after dental surgery or oral procedures. (3) (4)

Before taking hexetidine

Do not take / not appropriate for

  • Do not use if you have a known hypersensitivity (allergy) to hexetidine or to any excipient in the specific product, including azorubine (E122) colouring in some formulations. (all countries) (3)
  • Not recommended for children under 12 years, and contraindicated in children under 6 years, per the sourced product labels. (United Kingdom, European Union) (3) (4)
  • This product is for rinsing/gargling only and must not be swallowed. (all countries) (3) (4)

Tell your clinician about

  • Any past allergic reaction to hexetidine or to mouthwash/oral-rinse products.
  • Whether you are pregnant, planning pregnancy, or breastfeeding -- guidance differs between sourced labels because of the product's alcohol content (see special populations).
  • Any history of alcohol use disorder, liver disease, or epilepsy, since these products typically contain a notable amount of ethanol.
  • Whether your symptoms (mouth/throat infection, ulcers) persist beyond a few days, since persistent symptoms need clinical assessment rather than continued self-treatment.
(3) (4)

How to take hexetidine

  • Rinse the mouth or gargle with the undiluted solution, then spit it out -- do not swallow.
  • Used for a short course to manage minor symptoms; see a clinician or dentist if symptoms do not improve or if they worsen.
  • Not recommended for children under 12 years in the sourced UK and French product labels.
(3) (4)

Procedures and treatment changes

Tell the treating team before surgery, procedures, or any medicine change. Do not alter treatment without the responsible clinician. (1) (2) (3) (4) (5) (6) (7)

Missed dose

This is a topical rinse used a few times a day as needed for symptom relief, not a scheduled medicine with a strict dosing timeline -- if you miss a rinse, simply use it at the next opportunity. If you are unsure, check the specific product's patient leaflet or ask a pharmacist.

Overdose

This product is not meant to be swallowed. If a significant amount is swallowed accidentally (particularly in a child), or if you experience symptoms after use, contact a pharmacist, doctor, or poison control service for advice, partly because of the alcohol content of these formulations. (3) (4)

Side effects

Side effects and their urgency vary; report severe, persistent, or concerning symptoms.

Altered taste (dysgeusia) and dry mouth.

What to notice: Altered taste (dysgeusia) and dry mouth.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (3)

Local application-site reactions in the mouth.

What to notice: Local application-site reactions in the mouth.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (3)

Rarely, hypersensitivity reactions, including angioedema.

What to notice: Rarely, hypersensitivity reactions, including angioedema.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (3)

Serious warnings

Signs of a serious allergic reaction — emergency

Symptoms: Swelling of the face, lips, tongue, or throat (angioedema); difficulty breathing; widespread rash or hives.

Action: Get emergency medical help immediately and tell the treating team you have been using $1. (3)

Symptoms that do not improve or worsen — high caution

Symptoms: Persistent mouth or throat infection, worsening pain, spreading redness/swelling, or fever.

Action: Stop relying on self-treatment and see a doctor, dentist, or pharmacist -- persistent symptoms need clinical assessment, not continued mouthwash use alone. (3)

Interactions

  • No specific drug-drug interactions were identified in the sourced UK and French product labels for this topical antiseptic mouthwash, beyond the general caution around its alcohol content in people with alcohol use disorder, liver disease, or epilepsy. (4)

Pregnancy, breastfeeding, kidney/liver function, age

Pregnancy

Sourced labels genuinely differ: the UK Oraldene SmPC states use during pregnancy is considered highly unlikely to pose a risk to the foetus, given the product's limited systemic absorption when used as directed. The French ANSM entry for Hextril instead advises against use during pregnancy specifically because of the product's alcohol content. Discuss with a pharmacist or clinician before use in pregnancy. (1) (2) (3) (4) (5) (6) (7)

Breastfeeding

Similarly mixed: the UK label considers the risk low given limited absorption, while the French label states the product must not be used during breastfeeding because of alcohol excretion into breast milk. Discuss with a pharmacist or clinician before use while breastfeeding. (1) (2) (3) (4) (5) (6) (7)

Children

Not recommended for children under 12 years, and contraindicated under 6 years, per the sourced UK and French labels. (1) (2) (3) (4) (5) (6) (7)

Elderly

No specific dose adjustment or restriction identified in the sources reviewed. (1) (2) (3) (4) (5) (6) (7)

Hepatic_impairment

Caution advised in people with liver disease because of the product's alcohol (ethanol) content, per the French ANSM entry. (1) (2) (3) (4) (5) (6) (7)

Renal_impairment

No specific guidance identified in the sources reviewed for this topical product. (1) (2) (3) (4) (5) (6) (7)

Monitoring

Before starting

  • Check for known allergy to hexetidine or product excipients
  • Confirm age is appropriate for the product (12 years and older for standard use)

During treatment

  • Watch for any signs of allergic reaction after first use.
  • Reassess if mouth/throat symptoms have not improved within a few days of regular use.
(3)

Storage

Store at room temperature, out of reach of children, in the original container, and away from light and heat, as with most oral rinse products.

Professional information

Clinician-facing context only, sourced from the current UK SmPC and French ANSM national authorisation entry; verify against the current full label before recommending.

United Kingdom / European Union (France)

Indication: Minor oral/throat infection, gingivitis, oral hygiene, post-dental-surgery care

Dose summary: 0.1% solution, 15 mL undiluted rinse/gargle, 2-3 times daily, spit out after use; not recommended under 12 years.

Renal context: Not applicable -- topical/local use with minimal systemic absorption. (3) (4)

Mechanism of action

Hepatic guidance

Caution in significant liver disease because of the ethanol content of standard formulations.

Overdose note

Not intended for ingestion; accidental swallowing (especially in children) should be assessed with reference to the product's alcohol content, and poison control/medical advice sought if a significant amount is swallowed. (3) (4)

Frequently asked questions

Is hexetidine mouthwash available in the US, UK, Europe, Canada, Australia, and New Zealand?

It is currently authorised in the United Kingdom (as Oraldene) and in France and other EU member states (as Hextril and equivalent brands). It is no longer marketed in the United States (FDA-approved in 1956 as Sterisil, since discontinued), Canada (Steri/Sol, cancelled 2013), or Australia (Sterisol, cancelled 2015). Its status in New Zealand could not be confirmed after a direct search of Medsafe's records. (1) (2) (3) (4) (5) (6) (7)

Why was hexetidine mouthwash discontinued in some countries?

The sourced regulator records (Health Canada, Australia's TGA) show these specific products were cancelled at the sponsor's own request, not because of a safety recall or a formal ban. The exact commercial reasons for discontinuation are not detailed in the regulator records themselves. (5) (6)

Can hexetidine mouthwash be used during pregnancy?

Sourced product labels genuinely differ on this. The UK label considers the risk unlikely given how little of the product is absorbed into the body when used as directed, while the French label advises against use in pregnancy specifically because of the product's alcohol content. Ask a pharmacist or your clinician before using it if you are pregnant. (3) (4)

What is the mechanism of action of hexetidine?

Hexetidine is a pyrimidine-derivative antiseptic with broad-spectrum activity against Gram-positive and Gram-negative bacteria, yeasts (including Candida albicans), and some fungi, through binding to proteins with electronegative sites on microbial cell surfaces; it also has mild local-anaesthetic, astringent, and deodorant properties. Antibacterial activity has been reported to persist for 10-14 hours after a single application. (3) (4)

What is the generic name of Hexetidine?

The generic name is hexetidine. (3) (4)

What class of drug is hexetidine?

Hexetidine is classed as: Topical oral antiseptic (pyrimidine derivative). (3) (4)

References

  1. DailyMed search for 'hexetidine' -- 0 resultsU.S. National Library of Medicine, DailyMed (direct site search) · United States · accessed 2026-07-30 · source 1
  2. HEXETIDINE -- Inxight Drugs substance recordNCATS Inxight Drugs (part of NIH, U.S. National Institutes of Health) -- substance regulatory-status record · United States · accessed 2026-07-30 · source 2
  3. Oraldene 0.1% w/v mouthwash -- Summary of Product Characteristicselectronic medicines compendium (emc), United Kingdom -- product license holder · United Kingdom · accessed 2026-07-30 · source 3
  4. HEXTRIL 0,1 POUR CENT, bain de bouche (hexetidine 0.1%) -- official French medicines database entryAgence nationale de securite du medicament et des produits de sante (ANSM), France -- national marketing authorisation database · European Union (France, national authorisation) · accessed 2026-07-30 · source 4
  5. STERI/SOL LIQUID (hexetidine 0.1%) -- Drug Product Database entry, DIN 01946900Health Canada, Drug Product Database (DPD) · Canada · accessed 2026-07-30 · source 5
  6. STERISOL (Hexetidine 1mg/mL) Mouthwash -- ARTG 33546, cancelled under section 30(1)(c) of the Therapeutic Goods ActTherapeutic Goods Administration (TGA), Australia -- sponsor cancellation notice · Australia · accessed 2026-07-30 · source 6
  7. Medsafe site search for 'hexetidine' -- no data sheet or registration record foundMedsafe (New Zealand regulator) -- direct site search · New Zealand · accessed 2026-07-30 · source 7

Brand names by country

Single-ingredient hexetidine names are shown separately by country. Product availability, strengths, and supply rules can change; combination products are not included here.

Priority countries

United States

  • Sterisil (historical) (2) (1)FDA approved 1956 no longer marketed · 0.1% mouthwash (historical) · Warner/Chilcott (historical)

United Kingdom

  • Oraldene (3)MHRA licensed emc smpc confirmed · 0.1% w/v · Johnson & Johnson / Kenvue (UK licence holder)

Canada

  • Steri/Sol (5)Health Canada DIN cancelled post market 2013 · 0.1% · Johnson & Johnson Inc (Canada)

Australia

  • Sterisol (6)TGA ARTG cancelled 2015-06-29 sponsor request · 1 mg/mL · Johnson & Johnson Pacific Pty Ltd
View brands in additional countries.

European Union

Hextril (France, national authorisation; equivalent brands in other EU member states) (4)