Label: WALGREENS ANTICAVITY AND ANTIGINGIVITIS WHITENING- sodium fluoride 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 April 15, 2011

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  • Active Ingredient

    Sodium Fluoride 0.234% (0.15% w/v fluoride ion..........................Anticavity toothpaste

  • PURPOSE


  • WARNINGS

    As with all fluoride toothpastes, 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 the Poison Control Center immediately.


  • Directions

    Adults and children 6 years or older
    		Brush Teeth throughly, preferably after each meal, or at least twice a day, or as directed by your dentist.  Do not swallow.

    Children between 6 years and 12 yearsTo minimize swallowing, use a pea sized amount and supervise brushing until good habits are established.
    Children under 6 yearsAsk a dentist or physician,

  • Inactive Ingredients

    Sorbitol, Silica, Water, Glycerin, Sodium Laurel Sulphate, Zinc Citrate, Titanium Dioxide, Cellulose Gum, Flavor, PVP, Sodium Benzoate, Tetrasodium Pyrophosphate, Sodium Saccharine, Sodium Hydroxide, Carrageenan, Mica, FDC Blue No. 1.

  • Principal Display Panel

    image of container


  • KEEP OUT OF REACH OF CHILDREN


  • USE

    Helps protect against cavities.

  • INGREDIENTS AND APPEARANCE
    WALGREENS ANTICAVITY AND ANTIGINGIVITIS WHITENING  
    sodium fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0630
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Sodium Fluoride (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) Sodium Fluoride2.43 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Sorbitol (UNII: 506T60A25R)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Water (UNII: 059QF0KO0R)  
    Glycerin (UNII: PDC6A3C0OX)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    Zinc Citrate (UNII: K72I3DEX9B)  
    Titanium Dioxide (UNII: 15FIX9V2JP)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Carrageenan (UNII: 5C69YCD2YJ)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-0630-1024 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35511/24/2008
    Labeler - Walgreen (008965063)
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