Package.Label Principal Display Panel
SPL PATIENT PACKAGE INSERT SECTION
DESCRIPTION SECTION
INACTIVE INGREDIENT SECTION
CLINICAL PHARMACOLOGY SECTION
INDICATIONS & USAGE SECTION
CONTRAINDICATIONS SECTION
WARNINGS AND PRECAUTIONS SECTION
CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY SECTION
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 rates (3,4). In another study, no carcinogenicity was observed in rats treated with fluoride up to25 mg/kg of body weight (5). Overall, epidemiological studies do not show an association between fluoridated drinking water and increased cancer risks 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).