WARNINGS SECTION.

WARNINGS: DO NOTSWALLOW. An occasional accidental ingestion of usual treatment dose (athin ribbon) is harmless. If more than used for treatment is swallowed, administer calcium (e.g. milk) and get medical help or contact Poison Control Center right away. Keepout of the reach of infants and children under 12 years. Children under 12 years should use thisproduct only under adult supervision to prevent swallowing. Safety and effectiveness below age have not been established.

PREGNANCY SECTION.

Pregnancy:TeratogenicEffects: Pregnancy Category B. Fluoride readily crosses the placenta (7,9). Animal studies (rats and rabbits) have shown that fluorideis not teratogen (10,12,13). Maternal exposure to 18 mgFluoride/kg of body weight did not affect maternal body weight, litter size orfetal 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 withfluoridated water compared to areas with low fluoridated water (7). However,caution should be exercised when fluoride is administered to pregnant women.

GERIATRIC USE SECTION.

Geriatricuse: No overall differences in safety or effectivenesshave been observed between geriatric and younger patients. This drug is knownto be substantially excreted by the kidney, therefore the risk of toxicreactions to this drug may be greater in patients with impaired renal function.Because elderly patients are more likely to have decreased renal function, careshould be taken in dose selection, and it may be useful to monitor renalfunction.

NURSING MOTHERS SECTION.

Nursingmothers: Due to the relative insensitivity of human milkfluoride levels to changes in maternal fluoride intake, and due to the very lowconcentrations of fluoride in human milk, fluoride supplementation duringlactation would not be expected to significantly affect fluoride intake by thenursing infant (11). However, caution should be exercised when fluoride isadministered to nursing women.

OVERDOSAGE SECTION.

OVERDOSAGE:Accidental ingestion of large amounts of fluoride can result in acute irritationof the mouth and gastrointestinal tract as well as the development ofgastrointestinal symptoms such as nausea, vomiting, diarrhea, hematemesisepigastric cramping and abdominal pain. If large amounts of fluoride equal to or greaterthan mg fluoride/kg body weight (2.3 mg fluoride/lb body weight) areingested, give calcium (e.g. milk, 5% calcium gluconate or calcium lactate solution)orally to relieve gastrointestinal symptoms and admit immediately to hospitalfacility. treatment dose (approximately gram) of NeutraCare containsapproximately 5.1mg fluoride. One FL OZ (60ml) tube contains approximately336 mg fluoride.

PEDIATRIC USE SECTION.

Pediatricuse: The use of fluoride solutions, gels, and foamscontaining up to 1.23 fluoride ion as caries preventives in pediatricpatients aged to 16 years is supported by clinical studies in students aged 6to 12 years (1,2). Safety and effectiveness in pediatric patients below the ageof years has not been established. Please refer to CONTRAINDICATIONS andWARNINGS sections.

REFERENCES SECTION.

REFERENCES:(1.) Wellock, W.D. and Brudevold, F.: Arch. Oral Biol., 10, 453-460 (1965) (2.) Jiang, 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.

PRECAUTIONS SECTION.

PRECAUTIONS: Carcinogenesis, Mutagenesis, Impairment ofFertility: No evidence of carcinogenicity was observed infemale and male mice at doses ranging from 2.4 to 18.8 mg/kg sodium fluoride ofbody weight (3,4). Equivocal evidence of carcinogenicity was reported in malerats at doses ranging from 2.5 to 4.1 mg/kg fluoride, but no evidence ofcarcinogenicity was observed in female rats (3,4). In another study, nocarcinogenicity was observed in rats treated with fluoride up to 25 mg/kg ofbody weight (5). Overall, epidemiological studies do not show an associationbetween fluoridated drinking water and increased cancer risk in humans (7).Fluoride ion is not mutagenic in standard bacterial systems but has beenassociated with genetic aberrations in cultured human cells at doses muchhigher than expected for human exposure (6,8). Some in vivo studies reportchromosomal aberrations in rodents while other studies using similar protocolsreport negative results (7). Potential adverse reproductive effects offluoride exposure in humans have not been adequately evaluated. Adversereproductive effects of fluoride have been reported in animal studies, but athigh concentrations sufficient to produce other manifestations of toxicity (9).

ADVERSE REACTIONS SECTION.

ADVERSEREACTIONS: Developing teeth of children under age maybecome permanently discolored if excessive amounts are repeatedly swallowed.The following adverse reactions are possible in individuals hypersensitive tofluoride: eczema, atopic dermatitis, urticaria, gastric distress, headache andweakness. In patients with mucositis, gingival tissues may be hypersensitive tothe flavor.

CLINICAL PHARMACOLOGY SECTION.

CLINICALPHARMACOLOGY: Topical sodium fluoride preparations alter thecomposition and crystalline structure of tooth enamel promotingremineralization, increasing the resistance of tooth enamel to aciddissolution.

DOSAGE & ADMINISTRATION SECTION.

DOSAGE AND ADMINISTRATION: Adults and Children years and over:o Use daily after normal brushing and flossing,preferably at bedtime.o Apply thin ribbon of treatment to teeth with toothbrush and leave in place for one minute.o Expectorate. DO NOT SWALLOW.o Do not eat or drink for at least 30 minutes afterwards except children to 18 years who should rinse mouth thoroughly after use.Children under 12 years:o Should use this product only under adult supervision to prevent swallowing.

SPL PATIENT PACKAGE INSERT SECTION.

NeutraCareHome Topical Treatment (1.1% w/w Neutral Sodium Fluoride) Active Ingredient: Sodium Fluoride 1.1% w/w (0.5% fluoride ion).