Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Plastic bottle with child-resistant closure containing 16 fl. oz. (473 mL) (NDC 0126-0033-16). STORAGE Store at Controlled Room Temperature, 68-77°F (20-25°C).; PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label 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 PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label
- HOW SUPPLIED Plastic bottle with child-resistant closure containing 16 fl. oz. (473 mL) (NDC 0126-0033-16). STORAGE Store at Controlled Room Temperature, 68-77°F (20-25°C).
- PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label 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 PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label
Overview
PreviDent ® Rinse brand of 0.2% neutral sodium fluoride is a mint-flavored, neutral, aqueous solution. Active Ingredient Sodium Fluoride 0.2% (w/v) Inactive Ingredients Benzoic Acid, Flavor, Glycerin, Poloxamer 338, Propylene Glycol, Sodium Benzoate, Water, FD&C Blue No. 1
Indications & 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.)
Dosage & 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.
Warnings & Precautions
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
Contraindications
CONTRAINDIACTIONS Do not use in patients with dysphagia. Do not use in pediatric patients under age 6 years unless recommended by a dentist or physician.
Adverse Reactions
In patients with mucositis, gingival tissues may be hypersensitive to flavor present in formulation. Allergic reactions and other idiosyncrasies are rarely reported.
Storage & Handling
STORAGE Store at Controlled Room Temperature, 68-77°F (20-25°C).
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