Drug Catalog - Product Detail
SODIUM FLUORIDE GEL (SF 1.1% GEL) GEL 0.011 2OZ
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 60258-0151-01 | CYPRESS PHARMACEUTICAL | 56 | 1.1% | GEL |
PACKAGE FILES
Generic Name
1.1% SODIUM FLUORIDE
Substance Name
SODIUM FLUORIDE
Product Type
HUMAN PRESCRIPTION DRUG
Route
DENTAL
Application Number
Description
DESCRIPTION Self-topical neutral fluoride gel containing 1.1% (w/v) sodium fluoride for use as a dental caries preventive in pediatric patients and adults. This prescription product is not a dentifrice. Active Ingredient: Sodium Fluoride, USP 1.1% (w/v).
How Supplied
HOW SUPPLIED 2 oz. (56g) net wt. plastic tube. Flavor: Fresh Mint NDC 60258-151-01
Indications & Usage
INDICATIONS AND USAGE A dental caries preventive, for once daily self-applied topical use. It is well established that 1.1% sodium fluoride is safe and extraordinarily effective as a caries preventive when applied frequently with mouthpiece applicators. 1-4 SF 1.1% 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 whether or not drinking water is fluoridated since topical fluoride cannot produce fluorosis. (See WARNINGS for exception.)
Dosage and Administration
DOSAGE AND ADMINISTRATION Follow these instructions unless otherwise instructed by your dental professional: 1. 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. 2. After use, adults expectorate gel. For the best results, do not eat, drink, or rinse for 30 minutes. Pediatric patients, age 6-16, expectorate gel after use and rinse mouth thoroughly.