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Package. Label Principal Display Panel | Oral-B Neutra-Foam Mint

04:52 EDT 27th August 2014 | BioPortfolio

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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).

Geriatric use: No overall differences in safety or effectiveness have been observed between geriatric and younger patients. This drug is known to be substantially excreted by the kidney, therefore the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

ADVERSE REACTIONS: Developing teeth of children under age 6 may become permanently discolored if excessive amounts are repeatedly swallowed. The following adverse reactions are possible in individuals hypersensitive to fluoride: eczema, atopic dermatitis, urticaria, gastric distress, headache and weakness. In patients with mucositis, gingival tissues may be hypersensitive to the flavor.

REFERENCES: (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

Minute Foam Label 

Manufacturer

Oral-B Laboratories

Active Ingredients

Source

Drugs and Medications [496 Associated Drugs and Medications listed on BioPortfolio]

Denti-care denti-foam [AR Medicom Inc]

Denti-Care Denti-Foam 2.72 % Topical Sodium Fluoride Foam Mint

Darby [Darby Dental Supply Co]

DARBY Topical Fluoride Foam 2.72% NaF Mint

Kolorz [Medical Products Laboratories, Inc.]

kolorz Sixty Second Fluoride Foam Triple Mint

Oral-b minute-foam bubble gum [Oral-B Laboratories]

Package.Label Principal Display Panel

Oral-b minute-foam grape punch [Oral-B Laboratories]

Package.Label Principal Display Panel

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