Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPLLIED 3.4 FL OZ (100 mL) tube NDC 11527-755-34 STORAGE: Store at Controlled Room Temperature, 68-77°F (20-25°C); PRINCIPAL DISPLAY PANEL - 100 mL Tube Wentworth NDC 11527-755-34 Sodium Fluoride 5000 ppm SOOTHING MINT DRY MOUTH* 1.1% Sodium Fluoride, sls free formula Prescription Strength Toothpaste for Dry Mouth 3.4 FL OZ (100 mL) RX ONLY Wentworth Dry Mouth Tube.jpg; PRINCIPAL DISPLAY PANEL - 100 mL Carton Wentworth NDC 11527-755-34 Sodium Fluoride 5000 ppm SOOTHING MINT DRY MOUTH* 1.1% Sodium Fluoride, sls free formula Prescription Strength Toothpaste for Dry Mouth 3.4 FL OZ (100 mL) RX ONLY Wentworth Dry Mouth Carton.jpg
- HOW SUPLLIED 3.4 FL OZ (100 mL) tube NDC 11527-755-34 STORAGE: Store at Controlled Room Temperature, 68-77°F (20-25°C)
- PRINCIPAL DISPLAY PANEL - 100 mL Tube Wentworth NDC 11527-755-34 Sodium Fluoride 5000 ppm SOOTHING MINT DRY MOUTH* 1.1% Sodium Fluoride, sls free formula Prescription Strength Toothpaste for Dry Mouth 3.4 FL OZ (100 mL) RX ONLY Wentworth Dry Mouth Tube.jpg
- PRINCIPAL DISPLAY PANEL - 100 mL Carton Wentworth NDC 11527-755-34 Sodium Fluoride 5000 ppm SOOTHING MINT DRY MOUTH* 1.1% Sodium Fluoride, sls free formula Prescription Strength Toothpaste for Dry Mouth 3.4 FL OZ (100 mL) RX ONLY Wentworth Dry Mouth Carton.jpg
Overview
Self-topical neutral fluoride toothpaste containing 1.1% (w/w) sodium fluoride for use as a dental caries preventive in adults and pediatric patients.
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 5000 ppm Dry Mouth brand of 1.1% sodium fluoride toothpaste in a squeeze tube is easily applied onto a toothbrush. This prescription toothpaste should be used once daily in place of your 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.)
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 Sodium Fluoride 5000 ppm Dry Mouth to a toothbrush. Brush thoroughly once daily for two minutes, preferably at bedtime, in place of your regular toothpaste. After use, adults expectorate. For best results, do not eat, drink, or rinse for 30 minutes. Pediatric patients, ages 6-16 years, 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 cannot perform the brushing process without significant swallowing. Use in pediatric patients under age 6 years requires special supervision to prevent repeated swallowing of toothpaste which could cause dental fluorosis. Pediatric patients under age 12 should be supervised in the use of this product. 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, 68-77°F (20-25°C)
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