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Sodium Fluoride Dental Gel
  • Professionals
  • FDA PI

Sodium Fluoride Dental Gel

Dosage form: gel
Drug class:Mouth and throat products

Medically reviewed by Drugs.com. Last updated on May 1, 2022.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. Read further information about unapproved drugs.

Sodium Fluoride 1.1% Gel
1.1% Sodium Fluoride Prescription Dental Gel

Rx ONLY

Sodium Fluoride Dental Gel Description

Self-topical neutral fluoride gel containing 1.1% (w/v) sodium fluoride for use as a dental caries preventive in pediatric patients and adults. This prescription product is not a dentifrice.

Active Ingredient

Sodium Fluoride 1.1% (w/v).

Inactive Ingredients

FD&C Blue No. 1, glycerin, hydroxyethylcellulose, mint flavor, purified water, sodium benzoate, sodium saccharin, Sorbitol, xylitol.

Sodium Fluoride Dental Gel - Clinical Pharmacology

Frequent topical applications to the teeth with preparations having a relatively high fluoride content increase tooth resistance to acid dissolution and enhance penetration of the fluoride ion into tooth enamel.

Indications and Usage for Sodium Fluoride Dental Gel

A dental caries preventive, for once daily self-applied topical use. It is well established that 1.1% sodium fluoride is safe and extraordinarily effective as a caries preventive when applied frequently with mouthpiece applicators. Sodium Fluoride 1.1% Gel in a squeeze-tube is easily applied onto a toothbrush as well as a mouthpiece tray. This prescription dental gel should be used once daily following use of a regular toothpaste unless otherwise instructed by your dental professional. May be used whether or not drinking water is fluoridated since topical fluoride cannot produce fluorosis. (See WARNINGS for exception.)

Contraindications

Do not use in pediatric patients under age 6 years unless recommended by a dentist or physician.

Warnings

Prolonged d..