Label: PREVIDENT ALCOHOL FREE- sodium fluoride mouthwash
- NDC Code(s): 0126-0033-16
- Packager: Colgate Oral Pharmaceuticals, Inc.
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Updated July 11, 2022
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- SPL UNCLASSIFIED SECTION
- CLINICAL PHARMACOLOGY
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.)
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
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 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) or 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.
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.
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.
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.
- ADVERSE REACTIONS
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.
DOSAGE AND ADMINISTRATION
For caries — Adults and pediatric patients over age 6 years, 2 teaspoons (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.
- HOW SUPPLIED
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.
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label
INGREDIENTS AND APPEARANCE
PREVIDENT ALCOHOL FREE
sodium fluoride mouthwash
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0126-0033 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.9 mg in 1 mL Inactive Ingredients Ingredient Name Strength BENZOIC ACID (UNII: 8SKN0B0MIM) GLYCERIN (UNII: PDC6A3C0OX) POLOXAMER 338 (UNII: F75JV2T505) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SODIUM BENZOATE (UNII: OJ245FE5EU) WATER (UNII: 059QF0KO0R) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Product Characteristics Color BLUE (A clear blue solution) Score Shape Size Flavor MINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0126-0033-16 473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/13/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 06/13/2016 Labeler - Colgate Oral Pharmaceuticals, Inc. (968801118)