Label: WESTERN FAMILY COMPLETE 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 January 10, 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


  • INDICATIONS & USAGE

    Helps protect against cavities.

  • 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.

  • DOSAGE & ADMINISTRATION

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

    Children between                To minimize swallowing, use a pea-sized
    6 and 12 years                    amount and supervise brushing until
                                                 good habits are established.

    Children under 6 years       Ask a dentist or physician.


  • Inactive Ingredients:

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

  • Principal Display Panel

    image of container

  • INGREDIENTS AND APPEARANCE
    WESTERN FAMILY COMPLETE WHITENING 
    sodium fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55312-003
    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)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    CARRAGEENAN (UNII: 5C69YCD2YJ)  
    MICA (UNII: V8A1AW0880)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55312-003-01181.4 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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