Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED: Fresh Mint 2 oz. (56g) net wt. tube NDC# 35573-435-56 STORAGE: Store at Controlled Room Temperature, 20-25°C (68-77°F).; PRINCIPAL DISPLAY PANEL - 56 g Tube burelpharma NDC 35573-435-56 Rx only Sodium Fluoride 1.1% Dental Gel Prescription Brush-on Gel (non-abrasive formula) FRESH MINT NET WT. 2.0 OZ. (56 g) BurelPharma Fresh Mint 2 oz Tube; PRINCIPAL DISPLAY PANEL - 56 g Carton burelpharma NDC 35573-435-56 � Rx only Sodium Fluoride 1.1% Dental Gel Prescription Brush-on Gel (non-abrasive formula) FRESH MINT NET WT 2.0 oz (56g) BurelPharma Fresh Mint 2 oz Carton
- HOW SUPPLIED: Fresh Mint 2 oz. (56g) net wt. tube NDC# 35573-435-56 STORAGE: Store at Controlled Room Temperature, 20-25°C (68-77°F).
- PRINCIPAL DISPLAY PANEL - 56 g Tube burelpharma NDC 35573-435-56 Rx only Sodium Fluoride 1.1% Dental Gel Prescription Brush-on Gel (non-abrasive formula) FRESH MINT NET WT. 2.0 OZ. (56 g) BurelPharma Fresh Mint 2 oz Tube
- PRINCIPAL DISPLAY PANEL - 56 g Carton burelpharma NDC 35573-435-56 � Rx only Sodium Fluoride 1.1% Dental Gel Prescription Brush-on Gel (non-abrasive formula) FRESH MINT NET WT 2.0 oz (56g) BurelPharma Fresh Mint 2 oz Carton
Overview
Self-topical neutral fluoride gel containing 1.1% (w/v) sodium fluoride for use as a dental caries preventative in pediatric patients and adults. This prescription is not a dentifrice.
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 Sodium Fluoride 1.1% Dental Gel in a squeeze-tube is easily applied onto a toothbrush. This prescription dental gel should be used once daily following use of your 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: 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 after use and rinse mouth thoroughly.
Warnings & Precautions
WARNINGS: Prolonged daily ingestion may result in various degrees of dental fluorosis in pediatric patients under age 6 years, especially if the water fluoridation exceeds 0.6 ppm, since younger pediatric patients frequently can not perform the brushing process without significant swallowing. Use in pediatric patients under age 6 years requires special supervision to prevent repeated swallowing of dental gel, which could cause dental fluorosis. Read directions carefully before using. Keep out of reach of infants and children.
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. To report SUSPECTED ADVERSE REACTIONS, contact Sheffield Pharmaceuticals, LLC. at 1-800-222-1087 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Storage & Handling
STORAGE: Store at Controlled Room Temperature, 20-25°C (68-77°F).
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