Label: SMILEBAR WHITENING- sodium fluoride paste, dentifrice

  • Category: HUMAN OTC DRUG LABEL

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 December 8, 2020

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  • SPL UNCLASSIFIED SECTION

    Drug facts

  • ACTIVE INGREDIENT

    Active ingredient

    Sodium Fluoride 0.243%

  • PURPOSE

    Purpose

    Anticavity

  • INDICATIONS & USAGE

    Uses

    Helps protect against cavities

  • WARNINGS

    Warnings: Keep out of reach of children under 6 yrs. of age.

    If large amount (more than would be used for brushing) is swallowed, get medical help, or contact a Poison Control Center right away.

  • KEEP OUT OF REACH OF CHILDREN

  • DOSAGE & ADMINISTRATION

    Directions

    • Brush teeth thoroughly after

        meals or at least two times a day

       (or use as directed by a dentist)

    • Do not swallow
    • Not for children undre 6

  • INACTIVE INGREDIENT

    Inactive ingredients:  Glycerin, Water,

    Hydrated Silica, Sodium Lauryl Sulfate,

    Sodium Bicarbonate, PEG, CMC, Sodium

    Saccharin, Zinc Citrate, Flavor, Sucralose,

    Titanium Dioxide, Tri-calcium Phosphate

  • Package Labeling

          WHITENING TOOTHPASTE

    WITH FLUORIDE + BAKING SODA

    DESIGNED FOR CLEAR ALIGNER TREATMENT

          WHITENS                 PROTECTS GUMS

    FIGHTS CAVITIES      RESTORES ENAMEL

    NET WT 3.4 OZ  e96 G

          WHITENS TEETH BY REMOVING

    SURFACE STAINS, TARTER, AND PLAQUE               SMILEBAR.COM

    Distributed by SMILEBAR

    303 Columbus Ave

    Boston, MA 02116

    Smilebar 0.243

    res

  • INGREDIENTS AND APPEARANCE
    SMILEBAR WHITENING 
    sodium fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73449-001
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE2.43 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B)  
    CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    ZINC CITRATE (UNII: K72I3DEX9B)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRICALCIUM PHOSPHATE (UNII: K4C08XP666)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73449-001-0196 g in 1 TUBE; Type 0: Not a Combination Product11/15/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35511/15/2019
    Labeler - Smilebar (065798164)
    Registrant - Smilebar (065798164)
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