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SF Gel
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  • FDA PI

SF Gel

Generic name:sodium fluoride
Dosage form: gel
Drug class:Mouth and throat products

Medically reviewed by Drugs.com. Last updated on Jun 21, 2021.

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

SF 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, USP 1.1% (w/v).

Inactive Ingredients

Purified Water, Sorbitol, Hydroxyethylcellulose, Flavor, Poloxamer 407, Sodium Saccharin, Methylparaben, Propylparaben, FD&C Blue No. 1.

SF 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 SF 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.1-4 SF 1.1% Brush-On 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 daily ingestion may result in various degrees of dental fluorosis in pediatric patients under 6 years, especially if the water fluoridation exceeds 0.6 ppm, since younger pediatric patients frequently cannot perform the brushing process without significant swallowing. Use in pediatric patients un..