Label: PREVIDENT- sodium fluoride mouthwash

  • NDC Code(s): 0126-0179-16
  • Packager: Colgate Oral Pharmaceuticals, Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

Drug Label Information

Updated 08/12

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  • SPL UNCLASSIFIED SECTION

    Rx Only

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  • DESCRIPTION

    PreviDent® Rinse brand of 0.2% neutral sodium fluoride is a mint-flavored, neutral, aqueous solution containing 6% alcohol.

    Active Ingredient

    Sodium fluoride 0.2% (w/v).

    Inactive Ingredients

    benzoic acid, ethyl alcohol 6% (v/v), flavor, glycerin, poloxamer 338, sodium benzoate, water, FD&C blue no.1.

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  • CLINICAL PHARMACOLOGY

    Topical application of sodium fluoride increases tooth resistance to acid dissolution, promotes remineralization, and inhibits the cariogenic microbial process.

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  • INDICATIONS AND USAGE

    A dental caries preventive, for weekly self-applied topical use. Weekly rinsing with a neutral 0.2% sodium fluoride solution protects against dental caries in adults and pediatric patients. PreviDent® Rinse provides a ready-to-use preparation for convenient administration and favorable compliance. May be used in areas where drinking water is fluoridated since topical fluoride cannot produce fluorosis. (See WARNINGS for exception.)

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  • CONTRAINDICATIONS

    Do not use in patients with dysphagia. Do not use in pediatric patients under age 6 years unless recommended by a dentist or physician.

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  • WARNINGS

    Keep out of reach of infants and children. Pediatric patients under age 12 should be supervised in the use of this product. Patients under age 6 require special supervision to prevent repeated swallowing of rinse since they frequently swallow significant amounts while rinsing. Prolonged daily ingestion may result in dental fluorosis in patients under age 6, especially if the water fluoridation exceeds 0.6 ppm. Read directions carefully before using.

    DO NOT USE IF PRINTED NECK BAND IS BROKEN OR MISSING

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  • PRECAUTIONS

    General

    Not for systemic treatment. DO NOT SWALLOW.

    Carcinogenesis, Mutagenesis, Impairment of Fertility

    No carcinogenesis was found in mice or female rats treated with fluoride at doses ranging from 4.1 to 9.1 mg/kg of body weight. Equivocal evidence of carcinogenesis was reported in male rats treated with 2.5 and 4.1 mg/kg of body weight. In another study, no carcinogenesis was observed in rats treated with fluoride up to 11.3 mg/kg of body weight. Epidemiological data provide no credible evidence for an association between fluoride, either naturally occurring or added to drinking water, and risk of human cancer.

    Fluoride ion is not mutagenic in standard bacterial systems but has been associated with chromosome aberrations in cultured human and rodent cells at doses much higher than expected human exposures. Some in vivo report chromosome damage in rodents while other studies using similar protocols report negative results.

    Potential adverse reproductive effects of fluoride exposure in humans has not been adequately evaluated. Adverse effects on reproduction were reported for rats, mice, fox, and cattle exposed to 100 ppm or greater concentrations of fluoride in their diet or drinking water. Other studies conducted in rats demonstrated that lower concentrations of fluoride (5 mg/kg of body weight) did not result in impaired fertility and reproductive capabilities.

    Pregnancy

    Teratogenic Effects

    Pregnancy Category B

    It has been shown that fluoride crosses the placenta of rats, but only 0.01% of the amount administered is incorporated in fetal tissue. Animal studies (rats, mice, rabbits) have shown that fluoride is not a teratogen. Maternal exposure to 12.2 mg fluoride/kg of body weight (rats) of 13.1 mg/kg of body weight (rabbits) did not affect litter size or fetal weight and did not increase frequency of skeletal or visceral malformations. There are no adequate and well-controlled studies in pregnant women. However, epidemiological studies conducted in areas with high levels of naturally fluoridated water showed no increase in birth defects. Heavy exposure to fluoride during in utero development may result in skeletal fluorosis which becomes evident in childhood.

    Nursing Mothers

    It is not known if fluoride is excreted in human milk. However, many drugs are excreted in milk, and caution should be exercised when products containing fluoride are administered to a nursing woman. Reduced milk production was reported in farm-raised fox when the animals were fed a diet containing a high concentration of fluoride (98-137 mg/kg of body weight). No adverse effects on parturition, lactation, or offspring were seen in rats administered fluoride up to 5 mg/kg of body weight.

    Pediatric Use

    The use of PreviDent® Rinse as a weekly caries preventive in pediatric patients aged 6 to 16 years is supported by adequate and well-controlled clinical studies in students aged 6 to 12 years.1-4 Safety and effectiveness in pediatric patients below the age of 6 years have not been established. Please refer to the CONTRAINDICATIONS and WARNINGS sections.

    Geriatric Use

    Of the total number of subjects in clinical studies of 1.1% (w/v) sodium fluoride, 15 percent were 65 and over, while 1 percent were 75 and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. This drug is known to be substantially excreted by the kidney, and 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.

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  • ADVERSE REACTIONS

    In patients with mucositis, gingival tissues may be hypersensitive to flavor or alcohol present in formulation. Allergic reactions and other idiosyncrasies are rarely reported.

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  • OVERDOSAGE

    Accidental ingestion of large amounts of fluoride may result in acute burning in the mouth and sore tongue. Nausea, vomiting, and diarrhea may occur soon after ingestion (within 30 minutes) and are accompanied by salivation, hematemesis, and epigastric cramping abdominal pain. These symptoms may persist for 24 hours. If less than 5 mg fluoride/kg body weight (i.e. less than 2.3 mg fluoride/lb body weight) has been ingested, give calcium (e.g., milk) orally to relieve gastrointestinal symptoms and observe for a few hours. If more than 5 mg fluoride/kg body weight (i.e., more than 2.3 mg fluoride/lb body weight) has been ingested, induce vomiting, give orally soluble calcium (e.g., milk, 5% calcium gluconate or calcium lactate solution) and immediately seek medical assistance. For accidental ingestion of more than 15 mg fluoride/kg of body weight (i.e., more than 6.9 mg fluoride/lb body weight), induce vomiting and admit immediately to a hospital facility.

    A treatment dose (10 mL or two teaspoonfuls) of PreviDent® Rinse contains approximately 9 mg fluoride. One 16 fl. oz. bottle contains approximately 429 mg fluoride.

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  • DOSAGE AND ADMINISTRATION

    For caries — Adults and pediatric patients over age 6 years, 2 teaspoonfuls (10 mL). Once a week, preferably at bedtime after thoroughly brushing the teeth, rinse vigorously around and between the teeth for one minute, then expectorate. DO NOT SWALLOW. For maximum benefit, do not eat, drink, or rinse mouth for at least 30 minutes afterwards.

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  • HOW SUPPLIED

    Plastic bottle with child-resistant closure containing 16 fl. oz. (473 mL) (NDC 0126-0179-16).

    STORAGE

    Store at Controlled Room Temperature, 68-77°F (20-25°C).

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  • REFERENCES

    1. Driscoll WS, et al. Caries-preventive effects on school children daily and weekly fluoride mouthrinsing in a fluoridated community: final results after 30 months. JADA. 1982; 105: 1010-1013. 2. American Dental Association, Accepted Dental Therapeutics, Ed, 40, Chicago (1984): 403. 3. Ibid., p 405-407. 4. L.W. Ripa, G.S. Leske, and A. Sposato, Supervised Weekly Rinsing with a 0.2% Neutral NaF solution: Final Results of a Demonstration Program After Six School Years J. Pub. Health Dent., 43 (1983): 53-62.

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  • SPL UNCLASSIFIED SECTION

    Colgate Oral Pharmaceuticals, Inc., a subsidiary of Colgate-Palmolive Company
    New York, NY 10022 U.S.A.
    Questions/Comments: 1-800-962-2345
    www.colgateprofessional.com

    P10001292

    Rev. May 2009

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  • PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

    NDC 0126-0179-16

    Colgate®

    PreviDent®
    Rinse

    0.2% Neutral Sodium Fluoride

    Reduces caries up to 55%1

    COOL MINT

    KEEP OUT OF REACH OF
    INFANTS AND CHILDREN

    16 FL OZ (1 PT) 473 mL

    Rx Only

    Lot #

    Exp. Date

    PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label
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  • INGREDIENTS AND APPEARANCE
    PREVIDENT 
    sodium fluoride mouthwash
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0126-0179
    Route of Administration DENTAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Sodium Fluoride (Fluoride Ion) Sodium Fluoride 2 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    Water  
    Sodium Benzoate  
    Glycerin  
    Alcohol  
    Poloxamer 338  
    FD&C Blue No. 1  
    Benzoic Acid  
    Product Characteristics
    Color BLUE (clear blue) Score     
    Shape Size
    Flavor MINT Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0126-0179-16 473 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    UNAPPROVED DRUG OTHER 08/29/2012
    Labeler - Colgate Oral Pharmaceuticals, Inc. (055002195)
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