0.1% Hexetidine Solution | For Oral Hygiene Support | Mint Flavor | Ages 6+

Product Description
Hextril Menthe Mouthwash is an antiseptic oral rinse containing hexetidine (0.1%), designed for local oral hygiene support. It is commonly used in France as an adjunct for maintaining cleanliness in the mouth. Suitable for adults and adolescents, and for children ages 6–12 only on medical advice.

Active Ingredient
• Hexetidine 0.1% (0.100 g per 100 ml)

Other Ingredients
Purified water, polysorbate sodium, ethanol 96%, citric acid monohydrate, quinoline yellow, patent blue V, mint flavor.

Suggested Use
Adults & children 12+:
• Use 15 ml of solution, 2–3 times daily.
• May be used undiluted, or half-diluted with water if sensitivity occurs.

Children 6–12:
• Use only after medical advice.

To dilute: fill measuring cup to the 15 ml notch with Hextril, then top to the rim with water.

Do not continue use beyond 5 days unless directed.
Do not swallow.

Warnings
• Not for children under 6 years.
• Use in children ages 6–12 only with healthcare professional approval.
• Do not use if you have known hypersensitivity to hexetidine or any listed ingredients.
• Contains a small amount of alcohol (<100 mg per dose).
• Discontinue use and consult a healthcare professional if symptoms persist beyond 5 days.
• Do not use during pregnancy or breastfeeding unless advised by your doctor.
• Excessive use may cause neurological effects in children due to certain components.
• Avoid ingestion.
• Keep out of reach of children.

Storage
Store at room temperature.
See packaging for expiration date and lot number.

Packaging
200 ml bottle with measuring cup.

Please read the following full disclosure before purchasing our using this product.

SUMMARY OF PRODUCT CHARACTERISTICS (SPC / RCP)

ANSM – Updated: 20/05/2025

1. NAME OF THE MEDICINAL PRODUCT

HEXTRIL MENTHE 0.1%, mouthwash solution

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Hexetidine ...................................................................................... 0.1000 g
Per 100 ml of mouthwash solution.

Excipients with known effect: ethanol, sodium.

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Mouthwash solution.

4. CLINICAL DATA

4.1 Therapeutic indications

Local adjunct treatment of oral cavity conditions and post-operative care in stomatology.

4.2 Posology and method of administration

Posology

Adults and children 12 years and older:

HEXTRIL MENTHE 0.1%, mouthwash solution, is used pure or diluted, as a mouthwash: 1 dose 2 to 3 times per day.

Method of administration

Use the supplied measuring cup to measure the dose.

Pure: pour the solution into the measuring cup up to the 15 ml marking.

Diluted: if painful symptoms appear, use the solution diluted 1:1. Pour the solution up to the 15 ml marking and top up with water to fill the cup.

Rinse the mouth or gargle for 30 seconds. Do not swallow, spit out after use.

Paediatric population

HEXTRIL MENTHE 0.1% is not recommended for children under 12 years and is contraindicated in children under 6 years (see section 4.3).

4.3 Contraindications

• Hypersensitivity to the active substance or to one of the excipients listed in section 6.1.
• Children under 6 years.

4.4 Special warnings and precautions for use

This medicinal product is for local use only; the solution must not be swallowed.

The indication does not justify prolonged treatment, which could lead to imbalance of the normal microbial flora of the oral cavity.

This medicinal product contains terpenic derivatives, as excipients, which may lower the epileptogenic threshold. At excessive doses, risk of neurological events such as convulsions in infants and children. Comply with recommended doses and duration of treatment.

If symptoms persist or worsen beyond 5 days and/or if fever is present, or if new symptoms appear, stop treatment and consult a doctor.
Avoid prolonged use: do not exceed 5 days of treatment.

In patients with a history of epilepsy, take into account the presence of terpenic derivatives.

This medicinal product contains 0.650 g of ethanol per dose (15 ml). It is harmful for patients with alcoholism. It is not recommended for pregnant or breastfeeding women, children, and high-risk patients such as those with liver disease or epilepsy.

This medicinal product contains less than 1 mmol (23 mg) of sodium per dose, i.e., it is essentially “sodium-free.”

4.5 Interaction with other medicinal products and other forms of interaction

No known interactions with hexetidine.

4.6 Fertility, pregnancy and lactation

Pregnancy

Animal studies with hexetidine have shown no reproductive toxicity (see 5.3).
There are limited or no data on use during pregnancy.
Thus, HEXTRIL MENTHE 0.1% is unlikely to have an effect on the fetus when used during pregnancy.

Due to the presence of alcohol (see 4.4), use during pregnancy and in women of childbearing potential not using contraception is not recommended.

Breastfeeding

It is not known whether hexetidine or its metabolites are excreted in human milk. Alcohol is excreted in breast milk. A risk to breastfed newborns/infants cannot be excluded.
Therefore, due to the presence of alcohol, HEXTRIL MENTHE 0.1% must not be used during breastfeeding.

Fertility

No human data available on fertility.

4.7 Effects on ability to drive and use machines

Hexetidine has no or negligible influence on the ability to drive or use machines.

4.8 Undesirable effects

The following adverse effects have been reported during clinical trials and post-marketing surveillance. Frequencies are classified as follows:

Very common (≥1/10)
Common (≥1/100, <1/10)
Uncommon (≥1/1,000, <1/100)
Rare (≥1/10,000, <1/1,000)
Very rare (<1/10,000)
Frequency not known (cannot be estimated from available data)

Adverse effects by system organ class:

Immune system disorders

Frequency not known: Hypersensitivity*

Nervous system disorders

Frequency not known: Ageusia, dysgeusia

Respiratory, thoracic and mediastinal disorders

Frequency not known: Cough, dyspnea
*Observed in a context of hypersensitivity

Gastrointestinal disorders

Frequency not known: Dry mouth, dysphagia, nausea, vomiting, increased salivary gland secretion

Skin and subcutaneous tissue disorders

Frequency not known: Angioedema

General disorders and administration site conditions

Frequency not known: Local reactions at the administration site*
*Local reactions include cases reporting multiple MedDRA-preferred terms such as oral mucosal irritation, oral paresthesia, abnormal discoloration of the tongue or teeth, inflammation, ulceration, aphthae.

Due to the presence of terpenic derivatives and failure to observe recommended doses:

• risk of convulsions in infants and children
• possible agitation and confusion in the elderly

Reporting of suspected adverse reactions

Healthcare professionals should report suspected adverse reactions via the national reporting system:
ANSM & Regional Pharmacovigilance Centers – website: www.signalement-sante.gouv.fr

4.9 Overdose

In case of overdose, consult a doctor immediately.

Ingestion of large quantities of hexetidine in alcoholic solution may lead to symptoms of alcohol intoxication.

This medicinal product contains terpenic derivatives, which may lower the epileptogenic threshold and cause neurological effects (convulsions in children, agitation/confusion in the elderly) at excessive doses. Respect the recommended posology and treatment duration (see 4.2).

Hexetidine is not toxic at recommended doses. No data suggest that repeated excessive use could cause hypersensitivity reactions.

5. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic class: Local anti-infectives and antiseptics for oral treatment, ATC code: A01AB12.

Hexetidine is a fast-acting and long-acting antiseptic used for gingival-dental and oropharyngeal local treatment.

It has broad-spectrum antibacterial and antifungal activity against pathogens responsible for oropharyngeal infections.

Hexetidine also has healing, hemostatic, and local anesthetic properties in the mouth and pharynx.

5.2 Pharmacokinetic properties

No pharmacokinetic data in humans are available.
The product acts locally on the oral mucosa; only small amounts may be absorbed.

Hexetidine’s strong affinity for proteins with electronegative sites explains its binding to bacteria and its anti-plaque effect.
Its antibacterial effect can still be detected 10 to 14 hours after administration.

5.3 Preclinical safety data

Non-clinical data do not add any relevant additional information beyond what is already stated in other sections.

Animal data are insufficient to assess relevance; available data do not allow conclusions regarding effects on fertility, genotoxicity, or carcinogenicity.

Oral studies in rats and rabbits showed no teratogenic effects at maximum doses of 50 mg/kg/day and 20 mg/kg/day respectively.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Quinoline yellow, patent blue V, purified water, polysorbate 60, sodium saccharin, ethanol 96%, citric acid monohydrate, mint flavor 12202–34 (geranyl acetate, phenethyl alcohol, anethole, eucalyptol, eugenol, geraniol, essential oils of mint, spearmint, peppermint, white thyme, menthol, DL-menthol, nerol).

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

2 years.

6.4 Storage precautions

Store at temperature not exceeding 25°C.
Store the bottle in the outer packaging, protected from light.

6.5 Nature and contents of container

• 30 or 200 ml mouthwash solution in clear type III glass bottle with an aluminum cap and a 15 ml polypropylene measuring cup.
• 400 ml solution in PETP bottle with aluminum cap and 15 ml polypropylene measuring cup.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal

Any unused product or waste should be disposed of according to local regulations.

7. MARKETING AUTHORIZATION HOLDER

KENVUE FRANCE
43 Rue Camille Desmoulins
92130 Issy-les-Moulineaux
France

8. MARKETING AUTHORIZATION NUMBERS

• 34009 359 796 1 2: 30 ml glass bottle with measuring cup
• 34009 359 705 6 5: 200 ml glass bottle with measuring cup
• 34009 359 706 2 6: 400 ml PETP bottle with measuring cup

9. DATE OF FIRST AUTHORIZATION / RENEWAL

[To be completed later by the holder]

10. DATE OF REVISION OF THE TEXT

[To be completed later by the holder]

11. DOSIMETRY

Not applicable.

12. INSTRUCTIONS FOR RADIOPHARMACEUTICAL PREPARATION

Not applicable.

PRESCRIPTION / DISPENSING CONDITIONS

Medicinal product not subject to medical prescription.