Carcinogenesis, Mutagenesis, Impairment of Fertility: 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. CNRG06 Teratogenic Effects: Pregnancy Category B. 3 313029 sodium fluoride 0.02 % (fluoride ion 0.009 % ) Oral Rinse SY 4 313029 sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral Rinse SY DailyMed will deliver notification of updates and … For further information about unapproved drugs, click here. In another study, no carcinogenesis was observed in rats treated with fluoride up to 11.3 mg/kg of body weight. A treatment dose (10 mL or two teaspoonfuls) of PreviDent® Rinse contains approximately 9 mg fluoride. Available for Android and iOS devices. Neutral Sodium Fluoride 0.2% Dental Rinse provides a ready- to-use preparation for convenient administration and favorable compliance. 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. 3. We comply with the HONcode standard for trustworthy health information -. 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. Rev 6/06 1982;105(6):1010-1013. Keep out of reach of infants and children. Last updated on Oct 22, 2020. Keep out of the reach of infants and children. Please refer to the CONTRAINDICATIONS and WARNINGS sections. Patients under age 6 require special supervision to prevent repeated swallowing of rinse since they frequently swallow significant amounts while rinsing. 40, Chicago (1984):403 2. Pregnancy: Teratogenic Effects: Pregnancy Category B. Nursing Mothers: It is not known if fluoride is excreted in human milk. Denti-Care Denti-Foam Topical Sodium Fluoride Foam. 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. 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. Allergic reactions and other idiosyncrasies are rarely reported. Heavy exposure to fluoride during in utero development may result in skeletal fluorosis which becomes evident in childhood. PreviDent® Rinse brand of 0.2% neutral sodium fluoride is a mint-flavored, neutral, aqueous solution For maximum benefit, do not eat, drink, or rinse mouth for at least 30 minutes after treatment. Allergic reactions and other idiosyncrasies are rarely reported. DO NOT SWALLOW. Patients under age 6 require special supervision to prevent repeated swallowing of rinse since they frequently swallow significant amounts while rinsing. Read directions carefully before using. The PreviDent dental rinse with extra fluoride can help to decrease cavities in people that have trouble brushing. Description: Neutral Sodium Fluoride 0.2% Dental Rinse is a mint-flavored, neutral, aqueous solution containing 6% alcohol. p. 405-407. Store at Controlled Room Temperature, 20-25oC (68-77oF). Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. We are happy to present you a new, enhanced version of the #1 high strength sodium fluoride home-care rinse recommended by Canadian dental professionals: X-PUR Opti-Rinse Plus. Heavy exposure to fluoride during in utero development may result in skeletal fluorosis which becomes evident in childhood. May be used in areas where drinking water is fluoridated since topical fluoride cannot produce fluorosis. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Prolonged daily ingestion may result in dental fluorosis in patients under age 6, especially if water fluoridation exceeds 0.6 ppm. However, epidemiological studies conducted in areas with high levels of naturally fluoridated water showed no increase in birth defects. In another study, no carcinogenesis was observed in rats treated with fluoride up to 11.3 mg/kg of body weight. Fluoride ion is not mutagenic in standard bacterial systems but has been associated with chromosome aberrations in cultured human and rodent cells at doses much higher than expected human exposures. Caries-preventive effects on school children daily and weekly fluoride mouthrinsing in a fluoridated community: final results after 30 months. Equivocal evidence of carcinogenesis was reported in male rats treated with 2.5 and 4.1 mg/kg of body weight. A dental caries preventative for weekly self-applied topical use. Manufactured for: ACTIVE INGREDIENT: Sodium Fluoride 0.2% (w/v). 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). 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. Of the total number of subjects in clinical studies of 1.1% (w/v) sodium fluoride, 15 percent were 65 and over, while 1 percent were 75 and over. No adverse effects on parturition, lactation, or offspring were seen in rats administered fluoride up to 5 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. Keep out of reach of infants and children. DOSAGE AND ADMINISTRATION: For caries- Adults and pediatric patients over 6 years, 2 teaspoonfuls (10mL) once a week, preferably at bedtime after thoroughly brushing teeth, rinse vigorously around and between teeth for one minute, then expectorate. Leske, and A. Sposato, ”Supervised Weekly Rinsing with a 0.2% Neutral NaF Solution: Final Results of a Demonstration Program After Six School Years”. Neutral Sodium Fluoride 0.2% Ripa, G.S. Potential adverse reproductive effects of fluoride exposure in humans has not been adequately evaluated. NDC 60258-158-16 JADA. 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. Learn more about our commitment to oral health education. (See WARNINGS for exception.). Have questions about your smile? All rights reserved. Weekly rinsing with a neutral 0.2% sodium fluoride solution protects against dental caries in pediatric patients. Here is a specific and purposely … Accidental ingestion of large amounts of fluoride may result in acute burning in the mouth and sore tongue. (half-gallon office size) bottle contains approximately 1,717 mg fluoride. Geriatric Use: Of the total number of subjects in clinical studies of 1.1% (w/v) sodium fluoride, 15 percent were 65 and over, while 1 percent were 75 and over. Do not use in patients with dysphagia. 7/2008 Driscoll WS, Swango PA, Horowitz AM, et al. oz. Colgate Reaches Children in Need Across the Globe With the Power of a Bright Smile. (See WARNINGS for exception.). Epidemiological data provide no credible evidence for an association between fluoride, either naturally occurring or added to drinking water, and risk of human cancer. May be used in areas where drinking water is fluoridated since topical fluoride cannot produce fluorosis.
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