ORAL-B NEUTRACARE MINT
(neutral sodium fluoride)
|Category||DEA Schedule||Marketing Status|
|HUMAN PRESCRIPTION DRUG LABEL||unapproved drug other|
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.
• 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.
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).
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.
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)|