Sodium Fluoride Paste

Dosage form: dental paste
Drug class:Mouth and throat products

Medically reviewed by Drugs.com. Last updated on Jun 1, 2021.

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.

Rx Only

1.1% Sodium fluoride
Prescription Strength Toothpaste

Sodium Fluoride Paste Description

Self-topical neutral fluoride dentifrice containing 1.1% (w/w) sodium fluoride for use as a dental caries preventive in adults and pediatric patients.

Active Ingredient

Sodium Fluoride 1.1% (w/w)

Inactive Ingredients

Flavor, glycerin, hydrated silica, purified water, sodium benzoate, sodium lauryl sulfate, sodium saccharin, sorbitol, tetrasodium pyrophosphate, titanium dioxide, xanthan gum. This product also contains flavor, FD&C Blue #1 (Spearmint only), FD&C Red #40 (Fruity only)

Sodium Fluoride Paste - 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 Paste

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.1-4 Sodium Fluoride 5000 ppm 1.1% sodium fluoride in a squeeze-tube is easily applied onto a toothbrush. This prescription should be used once daily in place of your regular toothpaste, unless otherwise instructed by your dental professional. May be used in areas where 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 daily ingestion may result in various degrees of dental fluorosis in pediatric patients under age 6 years, especially if the water fluoridation e...