Label: DOLLAR SHAVE CLUB- sodium fluoride gel, 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 June 7, 2018

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Sodium fluoride 0.24%
    (0.15% w/v fluoride ion)

  • Purpose

    Anticavity

  • Use

    Aids in the prevention of dental cavities.

  • Warnings

    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 broken.

  • Directions

    • Adults and children 2 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice per day, or as directed by a dentist or physician.
    • Do not swallow.
    • Children under 6 years of age: Use a pea-sized amount and supervise until good brushing and rinsing habits are established (to minimize swallowing).
    • Children under 2 years of age: Consult a dentist or a physician.
  • Inactive Ingredients

    Sorbitol, Hydrated Silica, Glycerin, Xylitol, Purified Water, Sodium Lauryl Sulfate, Flavor, Xanthan Gum, Stevia Rebaudiana Leaf Extract, Blue 1 and Yellow 10.

  • PRINCIPAL DISPLAY PANEL - 142 g Tube Label

    SUPERBA

    PEPPERMINT KICK

    FLUORIDE GEL TOOTHPASTE

    NET WT 5.0 OZ (142g)

    PRINCIPAL DISPLAY PANEL - 142 g Tube Label
  • INGREDIENTS AND APPEARANCE
    DOLLAR SHAVE CLUB 
    sodium fluoride gel, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69522-1112
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Sodium fluoride (UNII: 8ZYQ1474W7) (fluoride ion - UNII:Q80VPU408O) fluoride ion1.5 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Sorbitol (UNII: 506T60A25R)  
    Hydrated silica (UNII: Y6O7T4G8P9)  
    WATER (UNII: 059QF0KO0R)  
    Xylitol (UNII: VCQ006KQ1E)  
    Glycerin (UNII: PDC6A3C0OX)  
    Xanthan Gum (UNII: TTV12P4NEE)  
    Sodium lauryl sulfate (UNII: 368GB5141J)  
    STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    Product Characteristics
    ColorGREENScore    
    ShapeSize
    FlavorMINT (Peppermint) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69522-1112-290 g in 1 TUBE; Type 0: Not a Combination Product06/28/2018
    2NDC:69522-1112-128 g in 1 TUBE; Type 0: Not a Combination Product06/28/2018
    3NDC:69522-1112-3142 g in 1 TUBE; Type 0: Not a Combination Product06/28/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35506/28/2018
    Labeler - Dollar Shave Club (004164494)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lornamead126440440MANUFACTURE(69522-1112)
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