Label: SUPERBA- sodium fluoride paste

  • 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 November 2, 2021

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  • Drug Facts

  • ACTIVE INGREDIENT

    Active Ingredient Sodium fluoride 0.234%

  • PURPOSE

    Purpose Anticavity

  • INDICATIONS & USAGE

    Use Aids in the prevention of dental cavities

  • WARNINGS

    Warnings

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away. Twist off cap to remove foil seal. Do not use if safety seal is missing or boken.

  • DOSAGE & ADMINISTRATION

    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. Do not swallow.
    • Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing). Supervise chldren as necessary until capable of using without supervision.
    • Children under 2 years of age: Consult a dentist or a doctor.
  • INACTIVE INGREDIENT

    Inactive Ingredients Sorbitol, Water/Aqua/Eau, Hydrated Silica, Glycerin, Xylitol, Cocamidopropyl Betain, Flavor (Aroma), Xanthan Gum, Titanium Dioxide (CI 77891), Stevia Rebaudiana Extract, Limonene, Linalool.

  • PRINCIPAL DISPLAY PANEL

    SUPERBA

    PEPPERMINT KICK

    FLUORIDE TOOTHPASTE

    SULFATE-FREE

    NET WT 5.0 OZ (142g)

    MANUFACTURED FOR

    DOLLAR SHAVE CLUB, INC.

    LOS ANGELES, CA 90292

    MADE IN SPAIN

    LABEL

  • INGREDIENTS AND APPEARANCE
    SUPERBA 
    sodium fluoride paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69522-1113
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    SORBITOL (UNII: 506T60A25R)  
    STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)  
    XYLITOL (UNII: VCQ006KQ1E)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    LINALOOL, (+)- (UNII: F4VNO44C09)  
    WATER (UNII: 059QF0KO0R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorPEPPERMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69522-1113-1142 g in 1 TUBE; Type 0: Not a Combination Product10/11/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35510/11/2021
    Labeler - Dollar Shave Club, Inc. (004164494)
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