Label: SMILE DIRECT CLUB- sensitivity 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

If you are a consumer or patient please visit this version.

View All Sections
  • Active Ingredient

    Sodium Fluoride 0.24%

  • Purpose

    Anticavity

  • Indications

    Aids in the prevention of dental decay.

  • Warnings

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

  • Keep out of reach

    Keep out of reach of children under 6 years 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, Stevia Rebaudiana Extract, Aloe Barbadensis Leaf Extract, Cocamidopropyl Betaine, Menthol.

  • Questions

    800-957-3409

  • Primary Packaging Label

    Primary Packaging Tube

  • Packaging Label - Carton

    Packaging Carton

  • INGREDIENTS AND APPEARANCE
    SMILE DIRECT CLUB 
    sensitivity toothpaste paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73333-126
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE2.4 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    POTASSIUM NITRATE (UNII: RU45X2JN0Z)  
    XYLITOL (UNII: VCQ006KQ1E)  
    STEVIA REBAUDIANA WHOLE (UNII: 6U422Y08O2)  
    MENTHOL (UNII: L7T10EIP3A)  
    MINT (UNII: FV98Z8GITP)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SORBITOL (UNII: 506T60A25R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73333-126-021 in 1 CARTON11/22/2019
    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 finalpart35511/22/2019
    Labeler - Nutrix International, LLC (117341868)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nutrix, LLC079833114manufacture(73333-126)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!