No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. JADA. A dental caries preventative for weekly self-applied topical use. Patients under age 6 require special supervision to prevent repeated swallowing of rinse since they frequently swallow significant amounts while rinsing. Rx Only Available for Android and iOS devices. In 2015 the U.S. Public Health Service [PHS] lowered its recommended maximum sodium fluoride concentration in drinking water from 1.2 to 0.7 mg/L. Some in vivo studies report chromosome damage in rodents while other studies using similar protocols report negative results. Keep out of reach of infants and children. 1982;105(6):1010-1013. For maximum benefit, do not eat, drink, or rinse mouth for at least 30 minutes after treatment. Neutral Sodium Fluoride 0.2% Dental Rinse is a grape flavored, neutral, aqueous solution containing no alcohol. No carcinogenesis was found in mice or female rats treated with fluoride at doses ranging from 4.1 to 9.1 mg/kg of body weight. Driscoll WS, Swango PA, Horowitz AM, et al. Nursing Mothers: It is not known if fluoride is excreted in human milk. WARNINGS: DO NOT SWALLOW. Description: Neutral Sodium Fluoride 0.2% Dental Rinse is a mint-flavored, neutral, aqueous solution containing 6% alcohol. Neutral Sodium Fluoride 0.2% Dental Rinse is a mint-flavored, neutral, aqueous solution containing 6% alcohol. Animal studies (rats, mice, rabbits) have shown that fluoride is not a teratogen. Pediatric Use. Maternal exposure to 12.2 mg fluoride/kg of body weight (rats) or 13.1 mg/kg of body weight (rabbits) did not affect litter size or fetal weight and did not increase frequency of skeletal or visceral malformations. (a) Sodium fluoride - (1) Dentifrices containing 850 to 1,150 ppm theoretical total fluorine in a gel or paste dosage form. Active ingredient: Sodium Fluoride 0.2% (w/v). ACTIVE INGREDIENT: Sodium Fluoride 0.2% (w/v). The use of Neutral Sodium Fluoride 0.2% Dental Rinse as a weekly caries preventative in pediatric patients aged 6 to 16 years is supported by adequate and well-controlled clinical studies in students aged 6 to 12 years.1-3 Safety and effectiveness in pediatric patients below the ages of 6 years have not been established. Pediatric patients under age 12 should be supervised in the use of this product. Cypress Pharmaceutical, Inc., © YYYY Colgate-Palmolive Company. Prolonged daily ingestion may result in dental fluorosis in patients under age 6, especially if water fluoridation exceeds 0.6 ppm. Patients under age 6 require special supervision to prevent repeated swallowing of rinse since they frequently swallow significant amounts while rinsing. Potential adverse reproductive effects of fluoride exposure in humans has not been adequately evaluated. The FDA has standards regarding about how much fluoride can be available in mouthwash that is sold over the counter, so pretty much everything out there won't be higher than .05% Sodium Fluoride. Prevent tooth decay with this weekly rinse. Equivocal evidence of carcinogenesis was reported in male rats treated with 2.5 and 4.1 mg/kg of body weight. Store at Controlled Room Temperature, 20-25oC (68-77oF). See package insert for additional information. It has been shown that fluoride crosses the placenta of rats, but only 0.01% of the amount administered is incorporated in fetal tissue.