Label: WALGREENS SCOOBY DOO FLUORIDE GEL TOOTHPASTE- sodium fluoride paste

  • 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 26, 2010

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  • Active Ingredients

    Sodium Fluoride 0.24%  Anticavity

  • PURPOSE

    Anticavity

  • 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 immediately.

  • Directions

    • do not swallow
    • instruct children under 6 years in good rinsing habits (to reduce swallowing)
    • supervise children as necessary until capable of using with our supervision
    • adults and children 2 years and over: brush teeth thoroughly after meals or at least twice a day, or as directed by a dentist or doctor
    • children under 2 years: consult a dentist or doctor
  • Inactive ingredients

    Sorbitol, Water, Hydrated Silica, Polyethylene Glycol 1450, Sodium Carboxymethylcellulose, Flavor, Sodium Lauryl Sulfate, Sodium Saccharin, Sodium Methylparaben, Mica, Propyparaben, Titanium Dioxide, D C Red 33, FD C Blue 1.
  • USE

    Aids in the prevention of dental decay.

  • Principal Display Panel

    image of container

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

  • INGREDIENTS AND APPEARANCE
    WALGREENS SCOOBY DOO FLUORIDE GEL TOOTHPASTE 
    sodium fluoride paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67659-085
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE2.4 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    POLYETHYLENE GLYCOL 1450 (UNII: OJ4Z5Z32L4)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    METHYLPARABEN SODIUM (UNII: CR6K9C2NHK)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Product Characteristics
    ColorpinkScore    
    ShapeSize
    FlavorBUBBLE GUMImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67659-085-01119 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35508/02/2010
    Labeler - Team Technologies, Inc (192339703)
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