Label: SMILE ACTIVE PRO TARTAR CONTROL FLUORIDE- sodium fluoride paste
- NDC Code(s): 70605-039-22, 70605-039-96
- Packager: Guthy-Renker LLC
- 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 November 23, 2022
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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 or older, brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician.
- To minimize swallowing, use a pea-sized amount for children under 6.
- Supervise children's brushing until good habits are established.
- Children under 2 years of age, ask a dentist or physician.
- Other information
- Inactive ingredients
- Questions or comments?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 170 g Tube Label
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INGREDIENTS AND APPEARANCE
SMILE ACTIVE PRO TARTAR CONTROL FLUORIDE
sodium fluoride pasteProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70605-039 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O) Sodium Fluoride 1.5 mg in 1 g Inactive Ingredients Ingredient Name Strength Sorbitol (UNII: 506T60A25R) Hydrated Silica (UNII: Y6O7T4G8P9) Water (UNII: 059QF0KO0R) Glycerin (UNII: PDC6A3C0OX) Xylitol (UNII: VCQ006KQ1E) Sodium Tripolyphosphate Anhydrous (UNII: 9SW4PFD2FZ) Cocamidopropyl Betaine (UNII: 5OCF3O11KX) Titanium Dioxide (UNII: 15FIX9V2JP) Sucralose (UNII: 96K6UQ3ZD4) Sodium Methyl Cocoyl Taurate (UNII: JVL98CG53G) Xanthan Gum (UNII: TTV12P4NEE) Sodium Ascorbyl Phosphate (UNII: 836SJG51DR) Glycine (UNII: TE7660XO1C) Hyaluronate Sodium (UNII: YSE9PPT4TH) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70605-039-22 57 g in 1 TUBE; Type 0: Not a Combination Product 04/01/2023 2 NDC:70605-039-96 170 g in 1 TUBE; Type 0: Not a Combination Product 04/01/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part355 04/01/2023 Labeler - Guthy-Renker LLC (948861877)