Oral-B NeutraCare Mint: Package Insert and Label Information

ORAL-B NEUTRACARE MINT — sodium fluoride gel
Oral-B Laboratories

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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.

WARNINGS:

• DO NOT SWALLOW. An occasional accidental ingestion of a usual treatment dose (a thin ribbon) is harmless. If more than used for treatment is swallowed, administer calcium (e.g. milk) and get medical help or contact a Poison Control Center right away.
• 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.

Pediatric 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 WARNINGS sections.

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. OVERDOSAGE: Accidental ingestion of large amounts of fluoride can result in acute irritation of the mouth and gastrointestinal tract as well as the development of gastrointestinal symptoms such as nausea, vomiting, diarrhea, hematemesis epigastric cramping and abdominal pain. If large amounts of fluoride equal to or greater than 5 mg fluoride/kg body weight (2.3 mg fluoride/lb body weight) are ingested, give calcium (e.g. milk, 5% calcium gluconate or calcium lactate solution) orally to relieve gastrointestinal symptoms and admit immediately to a hospital facility. A treatment dose (approximately a gram) of NeutraCare contains approximately 5.1mg fluoride. One 2 FL OZ (60ml) tube contains approximately 336 mg fluoride.

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.

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

NeutraCare

ORAL-B NEUTRACARE MINT neutral sodium fluoride gel

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0041-0241 Route of Administration DENTAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Sodium Fluoride (Fluoride ion) Fluoride ion 11 mg in 1 g

Product Characteristics Color Score Shape Size Flavor SPEARMINT (Mint Flavor) Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0041-0241-22 60 g in 1 CARTON None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 05/04/2000

Labeler — Oral-B Laboratories (183102243)

Revised: 03/2011 Oral-B Laboratories