Label: BRUSHBUDDIES BARBIE ANTICAVITY FLUORIDETOOTH- 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 August 2, 2018

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  • ACTIVE INGREDIENT

    Active Ingredient

    Sodium Monofluorophosphate 0.76%

  • PURPOSE

    Purpose:

    Anticavity Toothpaste

  • INDICATIONS & USAGE

    Uses:

    Help protect teeth and roots against cavities

  • WARNINGS

    Warnings:

    If morethan used for brushing is accidentally swallow more than used for brushing, seek professional help or contact a Poison Control Center immediately

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

  • DOSAGE & ADMINISTRATION

    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
    • To minimize swallowing use a pea-sized amount in children under 6 years of age,
    • Supervise children's brushing untill good habits are established.

    Children under 2 years of age:

    • Ask a dentist
  • INACTIVE INGREDIENT

    Inactive Ingredients:

    Sorbitor, Water, Silica, Sodium Lauryl Sulfate,  Xylitol, Flavor, Sodium Carboxymethylcellulose, Sodium Benzoate, Xanthan Gum, Saccharin Sodium, Rose Red 1

  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    BRUSHBUDDIES BARBIE ANTICAVITY FLUORIDETOOTH 
    sodium monofluorophosphate paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71106-003
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    XYLITOL (UNII: VCQ006KQ1E)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71106-003-01119 g in 1 TUBE; Type 0: Not a Combination Product08/02/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35508/02/2018
    Labeler - Foshan Nanhai Jiachun Biology Engineering Co., Ltd. (527935253)
    Establishment
    NameAddressID/FEIBusiness Operations
    Foshan Nanhai JiaChun Biology Engineering Co., Ltd527935253manufacture(71106-003)
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