Drug Facts
Composition & Profile
Identifiers & Packaging
How Supplied 3.4 FL OZ (100mL) net wt. tube NDC 69367-318-01 Mild Mint STORAGE Store at Controlled Room Temperature, 20°-25°C (68°-77°F); PRINCIPAL DISPLAY PANEL - 100 mL Tube Carton MILD MINT NDC 69367-318-01 Rx Only Sodium Fluoride 1.1% and Potassium Nitrate 5% Prescription Strength Toothpaste for Sensitive Teeth Sensitive 3.4 FL OZ (100 mL) Westminster Pharmaceuticals PRINCIPAL DISPLAY PANEL - 100 mL Tube Carton
- How Supplied 3.4 FL OZ (100mL) net wt. tube NDC 69367-318-01 Mild Mint STORAGE Store at Controlled Room Temperature, 20°-25°C (68°-77°F)
- PRINCIPAL DISPLAY PANEL - 100 mL Tube Carton MILD MINT NDC 69367-318-01 Rx Only Sodium Fluoride 1.1% and Potassium Nitrate 5% Prescription Strength Toothpaste for Sensitive Teeth Sensitive 3.4 FL OZ (100 mL) Westminster Pharmaceuticals PRINCIPAL DISPLAY PANEL - 100 mL Tube Carton
Overview
Self-topical neutral fluoride toothpaste containing 1.1% (w/w) sodium fluoride and 5% potassium nitrate. Active Ingredients Sodium Fluoride 1.1% (w/w) Potassium Nitrate 5% Inactive Ingredients D&C Yellow No.10, Dicalcium Phosphate, FD&C Blue No.1, Glycerin, Hydrated Silica, Mint Flavor, Purified Water, Sodium Benzoate, Sodium Luaryl Sulfate, Sodium Saccharin, Sorbitol, Titanium Dioxide, Xanthum Gum.
Indications & Usage
A dental caries preventive and sensitive teeth toothpaste; for twice daily self-applied topical use, followed by rinsing. Helps reduce the painful sensitivity of the teeth to cold, heat, acid, sweets or contact in adult patients and children 12 years of age and older. 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% and Potassium Nitrate 5% Sensitive in a squeeze-tube is easily applied onto a toothbrush. This prescription toothpaste should be used twice daily in place 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 children 12 years of age or older, apply at least a 1 inch strip of Sodium Fluoride 1.1% and Potassium Nitrate 5% Sensitive onto a soft bristle toothbrush. Brush teeth thoroughly for at least 1 minute, expectorate, and rinse mouth thoroughly. Use twice daily, (morning and evening) or as recommended by a dentist or physician. Make sure to brush all sensitive areas of the teeth. Children under 12 years of age: consult a dentist or physician.
Warnings & Precautions
WARNINGS Not for systemic treatment - DO NOT SWALLOW. Keep out of the reach of children. Children under 12 years of age, consult a dentist or physician. Note: Sensitive teeth may indicate a serious problem that may need prompt care by a dentist. See your dentist if the problem persists or worsens. Do not use this product longer than 4 weeks unless recommended by a dentist or physician.
Contraindications
Do not use in pediatric patients under age 12 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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