Self-topical neutral fluoride gel containing 1.1% sodium fluoride for use as a dental caries preventive in pediatric patients and adults. This prescription product is not a dentifrice.
INGREDIENTS
Active Ingredient: Sodium fluoride 1.1% (w/v)
Inactive Ingredient: Purified water, sorbitol solution 70%, hydroxyethylcellulose, pluronic F-127, flavor, sodium saccharin, methyl paraben, titanium dioxide, propylparaben, certified dyes (FD&C Red #40 In Bing Cherry and Very Berry flavors, FD&C Blue #1 in Fresh Mint flavor)
CLINICAL PHARMACOLOGY
Frequent topical applications to the teeth with preparations having a relatively high fluoride content increase tooth resistance to acid dissolution and enhance penetration of the fluoride ion into tooth enamel.
INDICATIONS AND USAGE
A dental caries preventive, for once daily self-applied topical use. PreviDent® Brush-On Gel in a squeeze-tube is easily applied onto a toothbrush as well as a mouthpiece tray. This prescription dental gel should be used once daily following use of a regular toothpaste unless otherwise instructed by your dental professional. May be used in areas where drinking water is fluoridated since topical fluoride cannot produce fluorosis. (See WARNINGS for exception.)
PRECAUTIONS
General: Not for systemic treatment. DO NOT SWALLOW.
ADVERSE REACTIONS
Allergic reactions and other idiosyncrasies have been rarely reported.
DOSAGE AND ADMINISTRATION:
Follow these instructions unless otherwise instructed by your dental professional:
- After brushing thoroughly with toothpaste, rinse as usual. Adults and pediatric patients 6 years of age or older, apply a thin ribbon of gel to the teeth with a toothbrush or mouth trays once daily for at least one minute, preferably at bedtime.
- After use, adults expectorate gel. For best results, do not eat, drink or rinse for 30 minutes. Pediatric patients, age 6-16, expectorate gel after use and rinse mouth thoroughly.