Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED 2 oz. (56g) net wt. plastic tube. Flavor: Fresh Mint NDC 69367-310-56 STORAGE Store at Controlled Room Temperature, 20° - 25° C (68° - 77° F). Rx only; PRINCIPAL DISPLAY PANEL - 56 g Tube Carton FRESH MINT NDC 69367-310-56 Rx Only Sodium Fluoride 1.1% GEL 1.1% SODIUM FLUORIDE Prescription Gel Brush-on Gel (non-abrasive formula) NET WT. 2 OZ. (56 g) Westminster Pharmaceuticals PRINCIPAL DISPLAY PANEL - 56 g Tube Carton
- HOW SUPPLIED 2 oz. (56g) net wt. plastic tube. Flavor: Fresh Mint NDC 69367-310-56 STORAGE Store at Controlled Room Temperature, 20° - 25° C (68° - 77° F). Rx only
- PRINCIPAL DISPLAY PANEL - 56 g Tube Carton FRESH MINT NDC 69367-310-56 Rx Only Sodium Fluoride 1.1% GEL 1.1% SODIUM FLUORIDE Prescription Gel Brush-on Gel (non-abrasive formula) NET WT. 2 OZ. (56 g) Westminster Pharmaceuticals PRINCIPAL DISPLAY PANEL - 56 g Tube Carton
Overview
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). Inactive Ingredients FD&C Blue No. 1, glycerin, hydroxyethylcellulose, mint flavor, purified water, sodium benzoate, sodium saccharin, sorbitol, xylitol
Indications & 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 & Administration
Follow these instructions unless otherwise instructed by your dental professional: 1. After brushing thoroughly with toothpaste, rinse as usual. Adults and pedatric 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.
Warnings & Precautions
WARNINGS Prolonged daily ingestion may result in various degrees of dental fluorosis in pediatric patients under 6 years, especially if the water fluoridation exceeds 0.6 ppm, since younger pediatric patients frequently cannot perform the brushing process without significant swallowing. Use in pediatric patients under age 6 years requires special supervision to prevent repeated swallowing of gel which could cause dental fluorosis. Read directions carefully before using. If using a mouthpiece application, prolonged exposure (longer than 1 minute) may result in oral irritation, such as burning. KEEP THIS PRODUCT OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSAGE, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.
Contraindications
Do not use in pediatric patients under age 6 years unless recommended by a dentist or physician.
Adverse Reactions
Allergic reactions and other idiosyncrasies have been rarely reported.
Storage & Handling
STORAGE Store at Controlled Room Temperature, 20° - 25° C (68° - 77° F). Rx only
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