Label: SMILE DIRECT CLUB- sodium fluoride toothpaste paste, dentifrice

  • 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 January 16, 2020

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  • Active Ingredient

    Sodium Fluoride 0.24%

  • Purpose

    Anticavity.

  • Indications and Usage Section

    Aids in the prevention of dental cavities.

  • Warnings

    If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center immedieately.

  • Keep out of Reach of Children

    Keep out of reach of children under 6 year of age.

  • 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.

    - 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

    Sorbitol, Hydrated Silica, Water (Agua), Glycerin, Xylitol, Sodium Lauryl Sulfate, Flavor, Xanthan Gum,Titanium Dioxide, Menthol, Stevia Rebaudiana Extract, Carrageenan.

  • Questions?

    800-957-3409

  • Principle package label

    Primary Packaging Label

  • Primary Packaging - Carton

    Primary Packaging - Carton

  • INGREDIENTS AND APPEARANCE
    SMILE DIRECT CLUB 
    sodium fluoride toothpaste paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73333-125
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION2.4 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    WATER (UNII: 059QF0KO0R)  
    XYLITOL (UNII: VCQ006KQ1E)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    MINT (UNII: FV98Z8GITP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)  
    CARRAGEENAN (UNII: 5C69YCD2YJ)  
    SORBITOL (UNII: 506T60A25R)  
    MENTHOL (UNII: L7T10EIP3A)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorMINT (Cool Mint) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73333-125-031 in 1 CARTON09/25/2019
    1125 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35509/25/2019
    Labeler - Nutrix International, LLC (117341868)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nutrix International,LLC117341868manufacture(73333-125)
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