Label: TOMS WHOLE CARE WINTERMINT - WWT4- sodium monofluorophosphate paste, dentifrice

  • Category: HUMAN OTC DRUG LABEL

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Drug Label Information

Updated December 6, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Sodium monofluorophosphate 0.76% (0.14% w/v fluoride ion)

  • Purpose

    Anticavity

  • Use

    helps protect against cavities

  • Warnings

    Keep out of reach of children under 6 years of age.

    If more than used for brushing is accidentally swallowed, get medical help or dial (412) 390-3381 right away (Poison Control Center).

  • Directions

    adults and children 2 years of age and olderbrush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician
    children 2 to 6 yearsuse only a pea-sized amount and supervise child's brushing and rinsing (to minimize swallowing)
    children under 2 yearsask a dentist or physician
  • Inactive ingredients

    water, hydrated silica, sorbitol, xylitol, glycerin, natural flavor1, sodium lauryl sulfate, zinc citrate, xanthan gum, titanium dioxide, carrageenan.

    1
    wintergreen oil and other natural flavor
  • Questions?

    1-800-FOR-TOMS (1-800-367-8667)

  • PRINCIPAL DISPLAY PANEL - 113 g Tube Carton

    SINCE 1970
    Tom's®
    OF MAINE

    with fluoride | natural

    WHOLE CARE®
    anticavity toothpaste

    6 BENEFITS

    fights cavities | promotes remineralization
    whitens teeth* | fights tartar buildup
    freshens breath | strengthens enamel

    wintermint

    4.0 OZ (113 g)

    PRINCIPAL DISPLAY PANEL - 113 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    TOMS WHOLE CARE WINTERMINT - WWT4 
    sodium monofluorophosphate paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51009-902
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.4 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SORBITOL (UNII: 506T60A25R)  
    CARRAGEENAN (UNII: 5C69YCD2YJ)  
    ZINC CITRATE (UNII: K72I3DEX9B)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    XYLITOL (UNII: VCQ006KQ1E)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorWINTERGREEN (Wintermint) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51009-902-401 in 1 CARTON11/19/2018
    1113 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35511/19/2018
    Labeler - Tom's of Maine, Inc. (052764354)
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