WESTERN FAMILY COMPLETE WHITENING (SODIUM FLUORIDE) PASTE, DENTIFRICE [WESTERN FAMILY FOODS, INC]

WESTERN FAMILY COMPLETE WHITENING (SODIUM FLUORIDE) PASTE, DENTIFRICE [WESTERN FAMILY FOODS, INC]
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NDC 55312-003-01
Set ID 082d3822-cd16-4394-9aca-e4753fd8e610
Category HUMAN OTC DRUG LABEL
Packager Western Family Foods, Inc
Generic Name
Product Class
Product Number
Application Number PART355
  • 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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