NDC 0041-0241 Oral-b Neutracare Mint

Spl Patient Package Insert

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

Description

DESCRIPTION:Oral-B
NeutraCare Home Topical Treatment is a mint flavored 1.1% w/w neutral sodium
fluoride aqueous solution.

Inactive Ingredient

Inactive
Ingredients:Purified
water, Sorbitol, Carbopol, Sodium hydroxide, Mint flavor, Methylparaben, Sodium
saccharin, Propylparaben.

Clinical Pharmacology

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.

Indications & Usage

INDICATION
AND USE:A once daily topical
neutral aqueous solution for the prevention of dental caries.

Contraindications

CONTRAINDICATIONS:        • Do not use in patients with hypersensitivity
to fluoride.                                            • Do not use in patients with dysphagia.

Warnings

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

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

Pregnancy:Teratogenic
Effects:   Pregnancy Category B. Fluoride readily crosses the placenta (7,9). Animal studies (rats and rabbits) have shown that fluorideis 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

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

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

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

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

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 & Administration

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

HOW SUPPLIED: NeutraCare is available in a plastic tube containing 2 FL OZ (60ml) in mint flavor, NDC 0041-241-22.

References

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