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.

Precautions

Not for systemic treatment. DO NOT SWALLOW.

Carcinogenesis, Mutagenesis, Impairment of Fertility

In a study conducted in rodents, no carcinogenesis was found in male and female mice and female rats treated with fluoride at dose levels ranging from 4.1 to 9.1 mg/kg of body weight. Equivocal evidence of carcinogenesis was reported in male rats treated with 2.5 and 4.1 mg/kg of body weight. In a second study, no carcinogenesis was observed in rats, males or females, treated with fluoride up to 11.2 mg/kg of body weight. Epidemiological data provide no credible evidence for an association between fluoride, either naturally occurring or added to drinking water, and risk of human cancer.

Fluoride ion is not mutagenic in standard bacterial systems. It has been shown that fluoride ion has the potential to induce chromosome aberrations in cultured human and rodent cells at doses much higher than those to which humans are exposed. In vivo data are conflicting. Some studies report chromosome damage in rodents while other studies using similar protocols report negative results.

Potential adverse reproductive effects of fluoride exposure in humans has not been adequately evaluated. Adverse effects on reproduction were reported for rats, mice, fox, and cattle exposed to 100 ppm or greater concentrations of fluoride in their diet or drinking water. Other studies conducted in rats demonstrated that lower concentrations of fluoride (5 mg/kg of body weight) did not result in impaired fertility and reproductive capabilities.

Pregnancy

Pregnancy Category B. It has been shown that fluoride crosses the placenta of rats, but only 0.01% of the amount administered is incorporated in fetal tissue.

Animal studies (rats, mice, rabbits) have shown that fluoride is not a teratogen. Maternal exposure to 12.2 mg fluoride/kg of body weight (rats) or 13.1 mg/kg of body weight (rabbits) did not affect the litter size or fetal weight and did not increase the frequency of skeletal or visceral malformations. There are no adequate and well controlled studies in pregnant women. However, epidemiological studies conducted in areas with high levels of naturally fluoridated water showed no increase in birth defects. Heavy exposure to fluoride during in utero development may result in skeletal fluorosis which becomes evident in childhood.

Nursing Mothers

It is not known if fluoride is excreted in human milk. However, many drugs are excreted in milk and caution should be exercised when products containing fluoride are administered to a nursing woman. Reduced milk production was reported in farm-raised fox when the animals were fed a diet containing a high concentration of fluoride (98-137 mg/kg of body weight). No adverse effects on parturition, lactation, or offspring were seen in rats administered fluoride up to 5 mg/kg of body weight.

Pediatric Use

The use of Stannous Fluoride 0.63% Concentrate Oral Rinse in pediatric patients 12 to 16 years of age is supported by an adequate and well-controlled study in school children.1 Safety and effectiveness in pediatric patients under the age of 12 have not been established. Please refer to the WARNINGS and CONTRAINDICATIONS sections.

Adverse Reactions/Side Effects

Allergic reactions and other idiosyncrasies are rarely reported.

Overdosage

Accidental ingestion of large amounts of fluoride may result in acute burning in the mouth and sore tongue. Nausea, vomiting, and diarrhea may occur soon after ingestion (within 30 minutes) and are accompanied by salivation, hematemesis, and epigastric cramping abdominal pain. These symptoms may persist for 24 hours. If less than 5 mg fluoride/kg body weight (i.e., less than 2.3 mg fluoride/lb body weight) have been ingested, give calcium (e.g., milk) orally to relieve gastrointestinal symptoms and observe for a few hours. If more than 5 mg fluoride/kg body weight (i.e., more than 2.3 mg fluoride/lb body weight) have been ingested, induce vomiting, give orally soluble calcium (e.g., milk, 5% calcium gluconate or calcium lactate solution) and immediately seek medical assistance. For accidental ingestion of more than 15 mg fluoride/kg of body weight (i.e., more than 6.9 mg fluoride/lb body weight), induce vomiting and admit immediately to a hospital facility.

A treatment dose (two one-minute applications) of Stannous Fluoride 0.63% Concentrate Oral Rinse contains 7.1 mg fluoride. One 10 oz. bottle contains 436 mg fluoride.

Stannous Fluoride Oral Rinse 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 is Stannous Fluoride Oral Rinse supplied

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

NDC 60258-159-10

Storage and Handling

Store at Controlled Room Temperature, 20°-25°C (68°-77°F). Keep tightly closed when not in use.

References

1AW Radike, CW Gish, JK Peterson, JD King and VA Segreto, "Clinical Evaluation of Stannous Fluoride as an Anticaries Mouthrinse." JADA (1973) 86, 404-408.

Manufactured By:

Emerald 3 Enterprises

Camdenton, MO 65020

Manufactured For:

Cypress Pharmaceuticals, Inc.

Madison, MS 39110

I169

04/06

Principal Display Panel

NDC 60258-159-10

Stannous Fluoride

0.63% Concentrate

Oral Rinse

Mint Flavor

Rx Only

Cypress Pharmaceutical, Inc.

Net Wt. 10 oz (283 g)

Additional product information is included on the enclosed package insert.

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

Directions for Use: Dilute as directed before using. 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 measuring cup. Add water to the 1 fl. oz. mark and mix. This prepares a 0.1% (w/v) stannous fluoride rinse. Use immediately after preparing the rinse. Place one half of the solution into the mouth and vigorously swish for 1 minute, then expectorate. Repeat the one-minute treatment with 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.

Storage: Store at Controlled Room Temperature. 20-20°C (68-77°F).

Keep tightly closed when not in use.

To report a serious adverse event or obtain product information, call 1-800-856-4393.

KEEP OUT OF REACH OF INFANTS AND CHILDREN.

Manufactured for: Cypress Pharmaceutical, Inc., Madison, MS 39110

Rev 11/10

L-357