Label: SMARTMOUTH PREMIUM ACTION SMARTMOUTH ADVANCED CLINICAL FORMULA (ACF)- sodium monofluorophosphate paste, dentifrice
- NDC Code(s): 76357-175-00
- Packager: Triumph Pharmaceuticals Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated February 7, 2023
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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 - 96.4 g Tube Label
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INGREDIENTS AND APPEARANCE
SMARTMOUTH PREMIUM ACTION SMARTMOUTH ADVANCED CLINICAL FORMULA (ACF)
sodium monofluorophosphate paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76357-175 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Sodium Monofluorophosphate (UNII: C810JCZ56Q) (Fluoride Ion - UNII:Q80VPU408O) Fluoride Ion 10.21 g in 96.4 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) Product Characteristics Color GREEN Score Shape Size Flavor MINT, VANILLA Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76357-175-00 96.4 g in 1 TUBE; Type 0: Not a Combination Product 02/01/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 02/01/2018 Labeler - Triumph Pharmaceuticals Inc. (017853461)