Label: WESTERN FAMILY SENSITIVE WHITENING FLUORIDE- potassium nitrate and sodium fluoride paste, dentifrice

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 February 18, 2011

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  • Active Ingredient

    Potassium Nitrate 5%..................Antihypersensitivity

    Sodium Fluoride 0.243% (0.15% w/v fluoride ion).......Anticavity Toothpaste

  • PURPOSE


  • KEEP OUT OF REACH OF CHILDREN


  • USE

    • builds increasing protection against painful sensitivity of teeth due to cold, heat, acids, sweets or contact
    • aids in the prevention of dental cavities
  • 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 problem persists or worsens.  Sensitive teeth may indicate a serious problem that may require prompt care by a dentist.  Keep out of reach of children.

  • 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.


  • Inactive Ingredients

    Sorbitol, Silica, Water, Sodium Lauryl Sulphate, Flavor, Cellulose gum, Titanium Dioxide, Sodium Benzoate, Sodium Phosphate, Tetrasodium Pyrophosphate, Sodium Saccharin

  • Principal Display Panel

    image of container

  • INGREDIENTS AND APPEARANCE
    WESTERN FAMILY SENSITIVE WHITENING FLUORIDE 
    potassium nitrate and sodium fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55312-158
    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)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    WATER (UNII: 059QF0KO0R)  
    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)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55312-158-09113 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35605/02/2007
    Labeler - Western Family Food, Inc. (192166072)
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