Stannous Fluoride Oral Rinse

Generic name: stannous fluoride
Dosage form: oral rinse
Drug class:Mouth and throat products

Medically reviewed by Drugs.com. Last updated on Nov 22, 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.

Stannous Fluoride Oral Rinse Description

Stannous Fluoride 0.63% Concentrate Oral Rinse is a stable, water-free concentrate containing 0.63% stannous fluoride for dilution to 0.1% stannous fluoride. This is a treatment rinse, not a mouthwash.

Active Ingredients: Stannous Fluoride 0.63% (w/w) (provides 0.1% (w/v) stannous fluoride when mixed).

Stannous Fluoride Oral Rinse - Clinical Pharmacology

Topical application of fluoride to the teeth increases tooth resistance to acid dissolution, promotes remineralization, and inhibits the cariogenic microbial process.

Indications and Usage for Stannous Fluoride Oral Rinse

For daily self-applied topical use as a dental caries preventive. It is well established that a 0.1% stannous fluoride rinse is a convenient way to apply fluoride to the surfaces of teeth to aid in the prevention of decalcification and dental caries. This is accomplished by increasing the resistance of tooth surfaces to acid dissolution.

Contraindications

Do not use in pediatric patients under age 12 years unless recommended by a dentist or physician. Not for systemic treatment.

Warnings

Pediatric patients under 12 years of age should be supervised in the use of this product. Prolonged daily ingestion may result in various degrees of dental fluorosis in pediatric patients under age 6 years, especially in areas with high fluoride concentration in drinking water. Use in pediatric patients under age 6 requires special supervision to prevent repeated swallowing of rinse. Do not use before mixing with water. This product may produce temporary surface staining of teeth. Adequate brushing may prevent these stains which are not harmful or permanent and may be removed by your dentist. Read directions carefully before using. Keep out of reach of infants and children.