WESTERN FAMILY SENSITIVE WHITENING FLUORIDE (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE, DENTIFRICE [WESTERN FAMILY FOOD, INC.]

WESTERN FAMILY SENSITIVE WHITENING FLUORIDE (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE, DENTIFRICE [WESTERN FAMILY FOOD, INC.]
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NDC 55312-158-09
Set ID 046dd282-fcd6-4fce-b636-5d6f576d6e72
Category HUMAN OTC DRUG LABEL
Packager Western Family Food, Inc.
Generic Name
Product Class
Product Number
Application Number PART356
  • 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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