WHOLE CARE (SODIUM FLUORIDE) PASTE, DENTIFRICE WHOLE CARE (SODIUM FLUORIDE) PASTE, DENTIFRICE WHOLE CARE (SODIUM FLUORIDE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]

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  • WHOLE CARE (SODIUM FLUORIDE) PASTE, DENTIFRICE WHOLE CARE (SODIUM FLUORIDE) PASTE, DENTIFRICE WHOLE CARE (SODIUM FLUORIDE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]

WHOLE CARE (SODIUM FLUORIDE) PASTE, DENTIFRICE WHOLE CARE (SODIUM FLUORIDE) PASTE, DENTIFRICE WHOLE CARE (SODIUM FLUORIDE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]
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NDC 51009-119-47, 51009-153-47, 51009-158-47
Set ID 76c9ac4b-207a-41e6-b8bb-f292e9a36873
Category HUMAN OTC DRUG LABEL
Packager Tom's of Maine, Inc.
Generic Name
Product Class
Product Number
Application Number PART355
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Sodium fluoride 0.24% (0.15% 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

    sorbitol, hydrated silica, water, glycerin, Citrus aurantium dulcis (orange) peel oil and other natural flavors, xylitol, sodium lauryl sulfate, zinc citrate, xanthan gum.

  • Questions?

    1-800-FOR-TOMS (1-800-367-8667) M - F 8:30 a.m. - 5:30 p.m. ET

  • PRINCIPAL DISPLAY PANEL - 133 g Carton

    Since 1970
    Tom's
    OF MAINE    ™

    with fluoride | natural

    WHOLE CARE®

    fights cavities | whitening | fresh breath | helps fight tartar
    fluoride toothpaste

    orange mango gel

    NET WT 4.7 OZ (133 g)

    Principal Display Panel - 133 g Carton
  • PRINCIPAL DISPLAY PANEL - 133 g Carton

    Since 1970
    Tom's
    OF MAINE    ™

    with fluoride | natural

    WHOLE CARE®

    fights cavities | whitening | fresh breath | helps fight tartar
    fluoride toothpaste

    peppermint gel

    NET WT 4.7 OZ (133 g)

    Principal Display Panel - 133 g Carton
  • PRINCIPAL DISPLAY PANEL - 133 g Carton

    Since 1970
    Tom's
    OF MAINE    ™

    with fluoride | natural

    WHOLE CARE®

    fights cavities | whitening | fresh breath | helps fight tartar
    fluoride toothpaste

    spearmint gel

    NET WT 4.7 OZ (133 g)

    Principal Display Panel - 133 g Carton
  • INGREDIENTS AND APPEARANCE
    WHOLE CARE   ORANGE MANGO
    sodium fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51009-119
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Sodium fluoride (UNII: 8ZYQ1474W7) (Fluoride ion - UNII:Q80VPU408O) Sodium fluoride0.00243 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Sorbitol (UNII: 506T60A25R)  
    Hydrated Silica (UNII: Y6O7T4G8P9)  
    Glycerin (UNII: PDC6A3C0OX)  
    Water (UNII: 059QF0KO0R)  
    Xylitol (UNII: VCQ006KQ1E)  
    Sodium lauryl sulfate (UNII: 368GB5141J)  
    Zinc citrate (UNII: K72I3DEX9B)  
    Xanthan gum (UNII: TTV12P4NEE)  
    Mango (UNII: I629I3NR86)  
    Orange Oil (UNII: AKN3KSD11B)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorORANGE, MANGO (Fruity) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51009-119-471 in 1 CARTON02/14/2011
    1133 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35502/14/2011
    WHOLE CARE   SPEARMINT
    sodium fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51009-153
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Sodium fluoride (UNII: 8ZYQ1474W7) (Fluoride ion - UNII:Q80VPU408O) Sodium fluoride0.00243 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Sorbitol (UNII: 506T60A25R)  
    Hydrated Silica (UNII: Y6O7T4G8P9)  
    Glycerin (UNII: PDC6A3C0OX)  
    Water (UNII: 059QF0KO0R)  
    Xylitol (UNII: VCQ006KQ1E)  
    Sodium lauryl sulfate (UNII: 368GB5141J)  
    Zinc citrate (UNII: K72I3DEX9B)  
    Xanthan gum (UNII: TTV12P4NEE)  
    Spearmint Oil (UNII: C3M81465G5)  
    Peppermint oil (UNII: AV092KU4JH)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorSPEARMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51009-153-471 in 1 CARTON02/14/2011
    1133 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35502/14/2011
    WHOLE CARE   PEPPERMINT
    sodium fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51009-158
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Sodium fluoride (UNII: 8ZYQ1474W7) (Fluoride ion - UNII:Q80VPU408O) Sodium fluoride0.00243 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Sorbitol (UNII: 506T60A25R)  
    Hydrated Silica (UNII: Y6O7T4G8P9)  
    Glycerin (UNII: PDC6A3C0OX)  
    Water (UNII: 059QF0KO0R)  
    Xylitol (UNII: VCQ006KQ1E)  
    Sodium lauryl sulfate (UNII: 368GB5141J)  
    Zinc citrate (UNII: K72I3DEX9B)  
    Xanthan gum (UNII: TTV12P4NEE)  
    Peppermint oil (UNII: AV092KU4JH)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorPEPPERMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51009-158-471 in 1 CARTON02/14/2011
    1133 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35502/14/2011
    Labeler - Tom's of Maine, Inc. (052764354)
    Establishment
    NameAddressID/FEIBusiness Operations
    Tom's of Maine, Inc.829517189MANUFACTURE(51009-119, 51009-153, 51009-158)
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