ORAL-B NEUTRACARE MINT — sodium fluoride gel
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.NeutraCare
Home Topical Treatment (1.1% w/w Neutral Sodium Fluoride)
Active Ingredient: Sodium Fluoride 1.1% w/w (0.5% fluoride ion)
DESCRIPTION: Oral-B NeutraCare Home Topical Treatment is a mint flavored 1.1% w/w neutral sodium fluoride aqueous solution.Inactive Ingredients:Purified water, Sorbitol, Carbopol, Sodium hydroxide, Mint flavor, Methylparaben, Sodium saccharin, Propylparaben. CLINICAL PHARMACOLOGY: Topical sodium fluoride preparations alter the composition and crystalline structure of tooth enamel promoting remineralization, increasing the resistance of tooth enamel to acid dissolution. INDICATION AND USE: A once daily topical neutral aqueous solution for the prevention of dental caries. CONTRAINDICATIONS: • Do not use in patients with hypersensitivity to fluoride.
• Do not use in patients with dysphagia.
• Keep out of the reach of infants and children under 12 years.
• Children under 12 years should use this product only under adult supervision to prevent swallowing. Safety and effectiveness below age 6 have not been established.
PRECAUTIONS : Carcinogenesis, Mutagenesis, Impairment of Fertility: No evidence of carcinogenicity was observed in female and male mice at doses ranging from 2.4 to 18.8 mg/kg sodium fluoride of body weight (3,4). Equivocal evidence of carcinogenicity was reported in male rats at doses ranging from 2.5 to 4.1 mg/kg fluoride, but no evidence of carcinogenicity was observed in female rats (3,4). In another study, no carcinogenicity was observed in rats treated with fluoride up to 25 mg/kg of body weight (5). Overall, epidemiological studies do not show an association between fluoridated drinking water and increased cancer risk in humans (7).
Fluoride ion is not mutagenic in standard bacterial systems but has been associated with genetic aberrations in cultured human cells at doses much higher than expected for human exposure (6,8). Some in vivo studies report chromosomal aberrations in rodents while other studies using similar protocols report negative results (7).
Potential adverse reproductive effects of fluoride exposure in humans have not been adequately evaluated. Adverse reproductive effects of fluoride have been reported in animal studies, but at high concentrations sufficient to produce other manifestations of toxicity (9).
Pregnancy:Teratogenic Effects: Pregnancy Category B. Fluoride readily crosses the placenta (7,9). Animal studies (rats and rabbits) have shown that fluoride
is not a teratogen (10,12,13). Maternal exposure to 18 mg Fluoride/kg of body weight did not affect maternal body weight, litter size or fetal weight and did not increase frequency of skeletal or visceral malformations (10). There are no adequate and well-controlled studies in pregnant women. Several epidemiological studies show no increase in birth defects in areas with fluoridated water compared to areas with low fluoridated water (7). However, caution should be exercised when fluoride is administered to pregnant women.
Nursing mothers: Due to the relative insensitivity of human milk fluoride levels to changes in maternal fluoride intake, and due to the very low concentrations of fluoride in human milk, fluoride supplementation during lactation would not be expected to significantly affect fluoride intake by the nursing infant (11). However, caution should be exercised when fluoride is administered to nursing women.
use: The use of fluoride solutions, gels, and foams
containing up to 1.23 % fluoride ion as caries preventives in pediatric
patients aged 6 to 16 years is supported by clinical studies in students aged 6
to 12 years (1,2). Safety and effectiveness in pediatric patients below the age
of 6 years has not been established. Please refer to CONTRAINDICATIONS and
DOSAGE AND ADMINISTRATION: Adults and Children 6 years and over:• Use daily after normal brushing and flossing, preferably at bedtime .
• Apply a thin ribbon of treatment to teeth with a toothbrush and leave in place for one minute.
• Expectorate. DO NOT SWALLOW.
• Do not eat or drink for at least 30 minutes afterwards except children 6 to 18 years who should rinse mouth thoroughly after use.
Children under 12 years:
• Should use this product only under adult supervision to prevent swallowing.
HOW SUPPLIED: NeutraCare is available in a plastic tube containing 2 FL OZ (60ml) in mint flavor, NDC 0041-241-22.
(1.) Wellock, W.D. and Brudevold, F.: Arch. Oral Biol., 10, 453-460 (1965) (2.) Jiang, H et al.: J. Dent, 33, 469-473 (2005) (3.) National Toxicology Program: NTP TR 393, NIH Publication 91-2842, (1990) (4.) Bucker, J.R. et al.: Int. J. Cancer 48, 733-737 (1991) (5.) Maurer, J.K. et al.: J. Natl. Cancer Inst. 82, 1118-1126 (1990) (6) Martin, G.R. et al.: Mutat. Res. 66, 159-167 (1979) (7.) Agency for Toxic Substances and Disease Registry: Toxicological Profile for Fluoride (2003)
(8.) Aardema, M.J. et al.: Mutat. Res. 331 (1), 171-172 (9.) National Research Council: Fluoride in Drinking Water (2006) (10.) Heindel, J.J. et al.: Fundam Appl Toxicol, 30, 162-177 (1996) (11.) Institute of Medicine, Food and Nutrition Board: Dietary Reference Intakes (1997) (12.) Collins, T.F. et al.: Food Chem. Toxicol. 33 (11), 951-960 (13.) Collins, T.F. et al.: Food Chem Toxicol. 39 (8), 867-876
|ORAL-B NEUTRACARE MINT neutral sodium fluoride gel|
|Labeler — Oral-B Laboratories (183102243)|
Revised: 03/2011 Oral-B Laboratories
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