Label: BARBIE BUBBLE GUM ANTICAVITY FLUORIDE- sodium fluoride paste, dentifrice

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated May 10, 2024

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  • Drug Facts

  • Active ingredient

    Sodium Fluoride 0.243%
    (Fluoride ion content 1100 ppm)

  • Purpose

    Anticavity

  • Uses

    helps protect teeth and roots against cavities.

  • Warnings

    Keep out of reach of children under 6 years of age. If you accidentally swallow more than used for brushing, seek professional help or contact a Poison Control Center immediately.

  • Directions

    • Adults and children 2 years and older: brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist.
    • Do not swallow.
    • Children 2 to 6 years: to minimize swallowing use a pea-sized amount and supervise children's brushing and rinsing until good habits are established.
    • Children under 2 years of age: Consult a dentist or doctor.

  • Inactive ingredients

    Sorbitol, Silica, Aqua, PEG-32, Xylitol, Sodium Lauryl Sulfate, Flavor, Cellulose Gum, Benzyl Alcohol, Sodium Benzoate, Sodium Saccharin, Trisodium Phosphate, FD & C Red # 40

  • Questions or comments?

    Call toll free 1-877-274-8358

  • SPL UNCLASSIFIED SECTION

    BrushBuddies®
    ANTICAVITY FLUORIDE TOOTHPASTE
    Bubble Gum Flavor
    Helps Prevent Cavities
    make brushing fun!®


    CAUTION:
    AVOID EXCESSIVE INGESTION.
    NOT FOR PETS.
    NOT TESTED ON ANIMALS.

    BARBIE™ and associated trademarks and trade dress are owned by, and used under license from, Mattel.
    ©2024 Mattel.

    DESIGNED IN U.S.A. • MADE IN INDIA

    Brush Buddies®
    WWW.BRUSHBUDDIES.COM

    1-909-434-0911 INTERNATIONAL
    PATENTS, COPYRIGHTS & TRADEMARKS GRANTED OR PENDING WORLDWIDE

    DISTRIBUTED BY ASHTEL STUDIOS INC.
    ONTARIO, CALIFORNIA 91761

  • Packaging

    Barbie Anticavity Fluoride toothpaste

  • INGREDIENTS AND APPEARANCE
    BARBIE BUBBLE GUM ANTICAVITY FLUORIDE 
    sodium fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70108-082
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE0.243 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    SORBITOL (UNII: 506T60A25R)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    WATER (UNII: 059QF0KO0R)  
    POLYETHYLENE GLYCOL 1600 (UNII: 1212Z7S33A)  
    XYLITOL (UNII: VCQ006KQ1E)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM PHOSPHATE, TRIBASIC, ANHYDROUS (UNII: SX01TZO3QZ)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    Product Characteristics
    ColorpinkScore    
    ShapeSize
    FlavorBUBBLE GUMImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70108-082-011 in 1 BOX05/21/2024
    1113 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02105/21/2024
    Labeler - Ashtel Studios Inc. (148689180)
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