RX ITEM-Stannous Flouride 0.63% Solution 10 Oz By Cypress Pharma

STANNOUS FLUORIDE - stannous fluoride rinse
Cypress Pharmaceutical, Inc.

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.
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).
CLINICAL PHARMACOLOGY

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

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.
General

Not for systemic treatment. DO NOT SWALLOW
DOSAGE AND ADMINISTRATION

Adults and pediatric patients 12 years and older: use at least daily, or more often as directed, following regular brushing and flossing. Pour the concentrated rinse to the 1/8 fluid ounce mark in the mixing vial. Add water to the 1 fl. oz. mark and mix. This prepares a 0.1% (w/v) stannous fluoride rinse. Place one half of the solution into the mouth and vigorously swish for 1 minute, then expectorate. Repeat the one-minute treatment with the remaining solution and expectorate. Pediatric patients under 12 years of age: consult a dentist or physician. Pediatric patients under 12 years of age should be supervised in the use of this product. For Home Irrigators: Prepare 1 fl. oz. of rinse as described above. Pour into irrigator reservoir and add 4 more fluid ounces of water. Mix thoroughly. This prepares a 0.02% (w/v) stannous fluoride rinse. Use irrigator as directed. Rinse the irrigator with water after use.
HOW SUPPLIED

Mint flavor in 10 oz. (283 g) net wt. plastic bottles with dispenser caps and mixing vial.

NDC 60258-159-10

RX ITEM-Stannous Flouride 0.63% Solution
NDC 60258-0159-10 UPC/GTIN No.3-60258-15910-4 Mfg.Part No.15910

Stannous Flouride 0.63% Solution 10 Oz B
BRAND: STANNOUS FLORIDE NDC: 60258-0159-10,60258015910 UPC: 3-60258-15910-4,360258159104 Cypress Pharm Inc.

STANNOUS FLUORIDE DENTAL
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