Label: WESTERN FAMILY WHITENING PLUS MINTY FRESH MOUTHWASH ANTICAVITY- 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 January 15, 2011

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  • Active Ingredient

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

  • PURPOSE


  • KEEP OUT OF REACH OF CHILDREN


  • Directions

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

    Children under                  To minimize swallowing, use a pea-sized
    6 years of age                  amount and supervise brushing until
                                              good habits are established.

    Children under 2 years     Ask a dentist or physician.     

  • Inactive Ingredients:

    Sorbitol, Water, Hydrated Silica, PEG-6, Sodium Lauryl Sulphate, Alcohol (1.14%), Flavor, Xanthan Gum, Carbomer, Sodium Benzoate, Titanium Dioxide, Tetrasodium Pyrophosphate, Sodium Saccharin, Triclosan, Blue 1, Yellow 4.

  • Principal Display Panel

    image of container

  • 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 a Poison Control Center immediately.
  • USE

    Helps protect against cavities.

  • INGREDIENTS AND APPEARANCE
    WESTERN FAMILY WHITENING PLUS MINTY FRESH MOUTHWASH ANTICAVITY 
    sodium fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55312-182
    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)  
    WATER (UNII: 059QF0KO0R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    ALCOHOL (UNII: 3K9958V90M) 1.14 mg  in 1 g
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    TRICLOSAN (UNII: 4NM5039Y5X)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorMINT (Striped Mint) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55312-182-05181.4 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35511/24/2008
    Labeler - Western Family Foods, Inc (192166072)
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