Complete SPL Sections#
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
0.2% Neutral Sodium Fluoride Rx ONLY
DESCRIPTION
DESCRIPTION SECTION
PreviDent ® Rinse brand of 0.2% neutral sodium fluoride is a mint-flavored, neutral, aqueous solution.
CLINICAL PHARMACOLOGY
CLINICAL PHARMACOLOGY SECTION
Topical application of sodium fluoride increases tooth resistance to acid dissolution, promotes remineralization, and inhibits the cariogenic microbial process.
INDICATIONS AND USAGE
INDICATIONS & USAGE SECTION
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.)
CONTRAINDIACTIONS
CONTRAINDICATIONS SECTION
Do not use in patients with dysphagia. Do not use in pediatric patients under age 6 years unless recommended by a dentist or physician.
WARNINGS
WARNINGS SECTION
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
PRECAUTIONS
PRECAUTIONS SECTION
ADVERSE REACTIONS
ADVERSE REACTIONS SECTION
In patients with mucositis, gingival tissues may be hypersensitive to flavor present in formulation. Allergic reactions and other idiosyncrasies are rarely reported.
OVERDOSAGE
OVERDOSAGE SECTION
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
DOSAGE & ADMINISTRATION SECTION
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
HOW SUPPLIED SECTION
Plastic bottle with child-resistant closure containing 16 fl. oz. (473 mL) (NDC 0126-0033-16).
REFERENCES
REFERENCES SECTION
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
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 P9913793 Rev. Jan 2016
PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 0126-0033-16 ALCOHOL FREE 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 P9923798
