Drug Facts
Composition & Profile
Identifiers & Packaging
How Supplied 3.4 FL OZ (100mL) NET WT. Tube NDC 69367-311-01 Spearmint 3.4 FL OZ (100mL) NET WT. Tube NDC 69367-312-01 Fruity STORAGE Store at Controlled Room Temperature, 20°-25°C (68°-77°F).; PRINCIPAL DISPLAY PANEL - 100 mL Tube Carton - SPEARMINT SPEARMINT NDC 69367-311-01 Rx Only Sodium Fluoride 5000 ppm 1.1% Sodium Fluoride Prescription Strength Toothpaste 3.4 FL OZ (100 mL) Westminster Pharmaceuticals PRINCIPAL DISPLAY PANEL - 100 mL Tube Carton - SPEARMINT; PRINCIPAL DISPLAY PANEL - 100 mL Tube Carton - FRUITY FRUITY NDC 69367-312-01 Rx Only Sodium Fluoride 5000 ppm 1.1% Sodium Fluoride Prescription Strength Toothpaste 3.4 FL OZ (100 mL) Westminster Pharmaceuticals PRINCIPAL DISPLAY PANEL - 100 mL Tube Carton - FRUITY
- How Supplied 3.4 FL OZ (100mL) NET WT. Tube NDC 69367-311-01 Spearmint 3.4 FL OZ (100mL) NET WT. Tube NDC 69367-312-01 Fruity STORAGE Store at Controlled Room Temperature, 20°-25°C (68°-77°F).
- PRINCIPAL DISPLAY PANEL - 100 mL Tube Carton - SPEARMINT SPEARMINT NDC 69367-311-01 Rx Only Sodium Fluoride 5000 ppm 1.1% Sodium Fluoride Prescription Strength Toothpaste 3.4 FL OZ (100 mL) Westminster Pharmaceuticals PRINCIPAL DISPLAY PANEL - 100 mL Tube Carton - SPEARMINT
- PRINCIPAL DISPLAY PANEL - 100 mL Tube Carton - FRUITY FRUITY NDC 69367-312-01 Rx Only Sodium Fluoride 5000 ppm 1.1% Sodium Fluoride Prescription Strength Toothpaste 3.4 FL OZ (100 mL) Westminster Pharmaceuticals PRINCIPAL DISPLAY PANEL - 100 mL Tube Carton - FRUITY
Overview
Self-topical neutral fluoride dentifrice containing 1.1% (w/w) sodium fluoride for use as a dental caries preventive in adults and pediatric patients. Active Ingredient Sodium Fluoride 1.1% (w/w) Inactive Ingredients Dicalcium phosphate, flavor, glycerin, hydrated silica, purified water, sodium benzoate, sodium lauryl sulfate, sorbitol, titanium dioxide, xanthan gum, xylitol. This product also contains flavor, FD&C blue No. 1 (Spearmint only), FD&C red No. 40 (Fruity only).
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 1.1% sodium fluoride in a squeeze-tube is easily applied onto a toothbrush. This prescription 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 to a toothbrush. Brush teeth thoroughly once daily for at least 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, 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 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 Westminster Pharmaceuticals, LLC at 1-844-221-7294 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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