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Whole Care (Tom's of Maine, Inc.)

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PASTE, DENTIFRICE 1 TUBE in 1 CARTON (51009-100-47) > 133 g in 1 TUBE Label Information

Complete Whole Care Information

  • SPL UNCLASSIFIED SECTION

    Drug Facts


  • Active ingredient

    Sodium monofluorophosphate 0.76% (0.13% 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 older brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician
    children 2 to 6 years use only a pea-sized amount and supervise child's brushing and rinsing (to minimize swallowing)
    children under 2 years ask a dentist or physician

  • Inactive ingredients

    glycerin, water, calcium carbonate, hydrated silica, xylitol, Chondrus crispus (carrageenan), sodium lauryl sulfate, sodium bicarbonate, zinc citrate, Cinnamomum cassia (cinnamon) leaf oil and other natural flavors.


  • 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
    â„¢

    with fluoride | natural

    WHOLE CARE®

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

    cinnamon clove

    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
    â„¢

    with fluoride | natural

    WHOLE CARE®

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

    peppermint

    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
    â„¢

    with fluoride | natural

    WHOLE CARE®

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

    spearmint

    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
    â„¢

    with fluoride | natural

    WHOLE CARE®

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

    wintermint

    NET WT 4.7 OZ (133 g)

    Principal Display Panel - 133 g Carton

  • INGREDIENTS AND APPEARANCE
    WHOLE CARE   CINNAMON CLOVE
    sodium monofluorophosphate paste, dentifrice
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:51009-100
    Route of Administration DENTAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Sodium monofluorophosphate (UNII: C810JCZ56Q) (fluoride ion - UNII:Q80VPU408O) Sodium monofluorophosphate 0.0076 g  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    Glycerin (UNII: PDC6A3C0OX)  
    Water (UNII: 059QF0KO0R)  
    Calcium carbonate (UNII: H0G9379FGK)  
    Hydrated Silica (UNII: Y6O7T4G8P9)  
    Xylitol (UNII: VCQ006KQ1E)  
    Carrageenan (UNII: 5C69YCD2YJ)  
    Zinc citrate (UNII: K72I3DEX9B)  
    Sodium Lauryl Sulfate (UNII: 368GB5141J)  
    Cinnamon leaf oil (UNII: S92U8SQ71V)  
    Clove oil (UNII: 578389D6D0)  
    Clove stem oil (UNII: 9368YZM9M4)  
    Product Characteristics
    Color WHITE (off-white) Score     
    Shape Size
    Flavor CINNAMON (Cinnamon-Clove) Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:51009-100-47 1 in 1 CARTON
    1 133 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part355 02/14/2011
    WHOLE CARE   PEPPERMINT
    sodium monofluorophosphate paste, dentifrice
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:51009-104
    Route of Administration DENTAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Sodium monofluorophosphate (UNII: C810JCZ56Q) (fluoride ion - UNII:Q80VPU408O) Sodium monofluorophosphate 0.0076 g  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    Glycerin (UNII: PDC6A3C0OX)  
    Water (UNII: 059QF0KO0R)  
    Calcium carbonate (UNII: H0G9379FGK)  
    Hydrated Silica (UNII: Y6O7T4G8P9)  
    Xylitol (UNII: VCQ006KQ1E)  
    Carrageenan (UNII: 5C69YCD2YJ)  
    Zinc citrate (UNII: K72I3DEX9B)  
    Sodium Lauryl Sulfate (UNII: 368GB5141J)  
    Peppermint Oil (UNII: AV092KU4JH)  
    Product Characteristics
    Color WHITE (off-white) Score     
    Shape Size
    Flavor PEPPERMINT Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:51009-104-47 1 in 1 CARTON
    1 133 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part355 02/14/2011
    WHOLE CARE   SPEARMINT
    sodium monofluorophosphate paste, dentifrice
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:51009-105
    Route of Administration DENTAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Sodium monofluorophosphate (UNII: C810JCZ56Q) (fluoride ion - UNII:Q80VPU408O) Sodium monofluorophosphate 0.0076 g  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    Glycerin (UNII: PDC6A3C0OX)  
    Water (UNII: 059QF0KO0R)  
    Calcium carbonate (UNII: H0G9379FGK)  
    Hydrated Silica (UNII: Y6O7T4G8P9)  
    Xylitol (UNII: VCQ006KQ1E)  
    Carrageenan (UNII: 5C69YCD2YJ)  
    Zinc citrate (UNII: K72I3DEX9B)  
    Sodium Lauryl Sulfate (UNII: 368GB5141J)  
    Spearmint Oil (UNII: C3M81465G5)  
    Peppermint Oil (UNII: AV092KU4JH)  
    Product Characteristics
    Color WHITE (off-white) Score     
    Shape Size
    Flavor SPEARMINT (Spearmint Ice) Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:51009-105-47 1 in 1 CARTON
    1 133 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part355 02/14/2011
    WHOLE CARE   WINTERMINT
    sodium monofluorophosphate paste, dentifrice
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:51009-106
    Route of Administration DENTAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Sodium monofluorophosphate (UNII: C810JCZ56Q) (fluoride ion - UNII:Q80VPU408O) Sodium monofluorophosphate 0.0076 g  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    Glycerin (UNII: PDC6A3C0OX)  
    Water (UNII: 059QF0KO0R)  
    Calcium carbonate (UNII: H0G9379FGK)  
    Hydrated Silica (UNII: Y6O7T4G8P9)  
    Xylitol (UNII: VCQ006KQ1E)  
    Carrageenan (UNII: 5C69YCD2YJ)  
    Zinc citrate (UNII: K72I3DEX9B)  
    Sodium Lauryl Sulfate (UNII: 368GB5141J)  
    Methyl salicylate (UNII: LAV5U5022Y)  
    Peppermint Oil (UNII: AV092KU4JH)  
    Product Characteristics
    Color WHITE (off-white) Score     
    Shape Size
    Flavor MINT (Wintermint) Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:51009-106-47 1 in 1 CARTON
    1 133 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part355 02/14/2011
    Labeler - Tom's of Maine, Inc. (052764354)
    Establishment
    Name Address ID/FEI Business Operations
    Tom's of Maine, Inc. 052764354 MANUFACTURE