Label: WALGREENS MAXIMUM STRENGTH SENSITIVE FLUORIDE- potassium nitrate and sodium fluoride paste

  • Category: HUMAN OTC DRUG LABEL

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

    Potassium nitrate 5%........................................... Antihypersensitivity

    Sodium Fluoride 0.243% (0.15% w/v fluoride ion).... Anticavity toothpaste
  • WARNINGS

    When using this product do not use longer than 4 weeks unless recommended by a dentist or doctor. Stop and ask a dentist if problems persists or worsens. Sensitive teeth may indicate a serious problem that may require prompt care by a dentist. Keep out of reach of children. If you accidentally swallow more that used for brushing seek professional help or contact a Poison Control Center immediately.
  • Directions

    Adults and children     Brush teeth for at least one minute, preferably after
    12 years and older      each meal, or at least twice a day or as directed by     
                                      your dentist. Be sure to brush sensitive areas.

    Children under               Consult a dentist or doctor
    12 years of age            

    Other information                Store in a cool, dry place.
  • USE

    • Builds increasing protection against painful sensitivity of teeth due to cold, heat, acids, sweets or contact
    • Aids in the prevention of dental cavities
  • Inactive Ingredients

    Sorbitol,Water, Silica, Sodium Lauryl Sulphate, Flavor, Cellulose Gum,Titanium Dioxide, Sodium Benzoate, Sodium Phosphate, Tetrasodium Pyrophosphate, Sodium Saccharin, FDC Blue No. 1, DC Yellow No.10
  • PURPOSE


  • KEEP OUT OF REACH OF CHILDREN


  • Principal Display Panel

    image of container

  • INGREDIENTS AND APPEARANCE
    WALGREENS MAXIMUM STRENGTH SENSITIVE FLUORIDE 
    potassium nitrate and sodium fluoride paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0631
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POTASSIUM NITRATE (UNII: RU45X2JN0Z) (POTASSIUM CATION - UNII:295O53K152) POTASSIUM NITRATE5 mg  in 1 g
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE2.43 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM PHOSPHATE (UNII: SE337SVY37)  
    SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorMINT (FRESH MINT) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-0631-09113 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35606/06/2006
    Labeler - Walgreens (008965063)
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