DENTEX S bain bouche Fl/300ml

Hydrogen peroxide..................................................................................................................................1,50 g

For 100 mL

as a hydrogen peroxide solution at 30 %.

Excipients with known effect :

1 mL of solution contains 73,64 mg of propylene glycol.

1 mL of solution contains 2.24 mg of flavouring with allergens.

For oral hygiene in cases of minor irritations of the mucosa and gums.

Do not use in children under 6 years.

DENTEX solution is ready to use.

Dosage

Rinse the mouth with 10 mL of solution (i.e. the contents of the dosing cap filled up to the line corresponding to 10 mL) for about one minute, then spit out.

Use 3 times a day (after meals and at bedtime) or as advised by the dentist.

Adults and children over 12 years : to be used as described above.

For children aged 6 to 12 years : to be used under the supervision of an adult.

The duration of use must not exceed 7 days.

Method of administration

For oral use.

Hypersensitivity to the active substance or to any of the excipients listed in section Composition.

DO NOT SWALLOW.

Consulting a dentist becomes essential:

• if the irritation persists beyond 7 days,

• in case of severe irritation,

• if the irritation is due to wearing dentures or orthodontic appliances,

• if there is inflammation of the mucous membranes,

• if there is fever,

Excessively high doses of hydrogen peroxide may damage the mucous membranes, and prolonged use of hydrogen peroxide may cause reversible hypertrophy of the lingual papillae, also called "hairy black tongue". Therefore, it is not recommended to use DENTEX for too long and at excessively high doses.

Avoid any contact with the eyes.

This medicine contains propylene glycol, which may cause skin irritation.

This medicine also contains allergenic flavourings (linalool and d-limonene). These allergens may cause allergic reactions.

Not known.

In pregnant women, there are currently no sufficiently relevant clinical data to evaluate the use of hydrogen peroxide used as a mouthwash.

It is therefore not advised to use DENTEX without medical advice during pregnancy.

Cases of irritation and inflammation of the oral mucosa have been reported, especially at high doses or with prolonged use (see section Warnings and precautions). These reactions disappear when use of DENTEX, mouthwash solution, is stopped.

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 reaction via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Centres of Pharmacovigilance - Website: https://signalement.social-sante.gouv.fr.

An overdose is not expected with DENTEX, which is a diluted solution of hydrogen peroxide. The symptoms of an overdose would rather be associated with more concentrated solutions (30-40 %) of hydrogen peroxide.

In case of accidental ingestion of an excessive quantity of DENTEX, the levomenthol it contains may cause convulsions, particularly in infants and children.

Pharmacotherapeutic class: Stomatological preparations - Anti-infectives and antiseptics for local oral treatment – Hydrogen peroxide, ATC code: A01AB02.

Hydrogen peroxide is a local antiseptic used in the mouth.

The main action results from the contact of hydrogen peroxide with the peroxidases and catalases present in tissues and saliva, which allows rapid release of oxygen. It is a mechanical cleansing action which, by removing food debris, helps relieve certain minor irritations of the oral cavity.

In the mouth, hydrogen peroxide releases water and oxygen under the action of salivary peroxidase.

Low doses of hydrogen peroxide do not produce tissue alteration or carcinogenic effects. Application of DENTEX for 21 days on the abraded cheek mucosa of hamsters showed no undesirable effect.

Hydrogen peroxide was not shown to be teratogenic in animals. Reproductive toxicology data, although incomplete, did not indicate any toxic effect at low concentrations.

2 years

Store at a temperature not exceeding 25 °C

No special requirements.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.