Label: BARBIE- sodium monofluorophosphate 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 July 27, 2018

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  • Drug Facts

  • Active Ingredients

    Sodium Monofluorophosphate 0.76%

  • Purpose

    Anticavity Toothpaste

  • Uses

    Helps protect teeth and roots against cavities.

  • Warning

    If more than used for brushing is accidently swallowed, seek professional assistance or contact a Poison Control Center immediately.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN.

  • Directions

    Adults and children 2 years of age and older:

    • Brush teeth thoroughly after meals or at least twice a day. Use as directed by a dentist.
    • Do not swallow.
    • To minimize swallowing, use a pea-sized amount in children under 6 years of age.
    • Supervise children's brushing until good brushing habit are established.
    • Children under 2 years of age: Ask a dentist.
  • Inactive Ingredients

    Sorbitol, Water, Silica, Sodium Lauryl Sulfate, Xylitol, Flavor, CMC Sodium Carboxymethyl Cellulose, Sodium Benzoate, Xanthan Gum, Saccharin Sodium, Rose Red

  • Other Information

    Store at room temperature.

  • SPL UNCLASSIFIED SECTION

    BUBBLE GUM FLAVOR

    HELPS PREVENT CAVITIES!

    ANTICAVITY FLUORIDE TOOTHPASTE

    Alcohol & Sugar Free

    QUESTIONS OR COMMENTS?

    1-877-274-8358 (U.S.A.)

    1-909-434-0911 (INTERNATIONAL)

    ONTARIO, CA 91761

    DESIGNED IN U.S.A.

    MADE IN CHINA

    DISTRIBUTED BY ASHTEL STUDIOS INC.

  • Packaging

    Barbienw

  • INGREDIENTS AND APPEARANCE
    BARBIE 
    sodium monofluorophosphate paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70108-016
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.76 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    XYLITOL (UNII: VCQ006KQ1E)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    ROSE BENGAL SODIUM (UNII: 956575SN5L)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorBUBBLE GUMImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70108-016-01119 g in 1 TUBE; Type 0: Not a Combination Product07/25/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35507/25/2018
    Labeler - Ashtel Studios, Inc. (148689180)
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