Label: SMARTMOUTH ADVANCE CLINICAL FORMULA- sodium monofluorophosphate paste, dentifrice
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Contains inactivated NDC Code(s)
NDC Code(s): 76357-106-04 - Packager: Triumph Pharmaceuticals Inc.
- Category: HUMAN OTC DRUG LABEL
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Drug Label Information
Updated January 12, 2021
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredient
- Purpose
- Use
- Warnings
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Directions
- Adults and children 2 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor.
- Children 2 to 6 years of age: Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision.
- Children under 2 years of age: Consult a dentist or doctor.
- Inactive Ingredients
- Questions or comments
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 170 g Tube Label
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INGREDIENTS AND APPEARANCE
SMARTMOUTH ADVANCE CLINICAL FORMULA
sodium monofluorophosphate paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76357-106 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Sodium Monofluorophosphate (UNII: C810JCZ56Q) (Fluoride Ion - UNII:Q80VPU408O) Fluoride Ion 1 mg in 1 g Inactive Ingredients Ingredient Name Strength Sorbitol (UNII: 506T60A25R) Hydrated Silica (UNII: Y6O7T4G8P9) Glycerin (UNII: PDC6A3C0OX) Water (UNII: 059QF0KO0R) Sodium Lauryl Sulfate (UNII: 368GB5141J) Titanium Dioxide (UNII: 15FIX9V2JP) Xanthan Gum (UNII: TTV12P4NEE) Sodium Benzoate (UNII: OJ245FE5EU) Benzoic Acid (UNII: 8SKN0B0MIM) Saccharin Sodium (UNII: SB8ZUX40TY) Zinc Chloride (UNII: 86Q357L16B) D&C Yellow No. 10 (UNII: 35SW5USQ3G) FD&C Blue No. 1 (UNII: H3R47K3TBD) Product Characteristics Color GREEN Score Shape Size Flavor MINT (mint vanilla) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76357-106-04 170 g in 1 TUBE; Type 0: Not a Combination Product 06/17/2011 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part355 06/17/2011 Labeler - Triumph Pharmaceuticals Inc. (017853461)