Label: TOM WHOLE CARE PEPPERMINT FIGHTS CAVITIES WHITENING FRESH BREATH HELPS FIGHT TARTAR- sodium monofluorophosphate paste, dentifrice

  • NDC Code(s): 51009-202-04, 51009-202-47
  • Packager: Tom's of Maine, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 14, 2024

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  • 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 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

    glycerin, water, calcium carbonate, hydrated silica, xylitol, natural flavor1, sodium lauryl sulfate, carrageenan, zinc citrate, sodium bicarbonate, benzyl alcohol.

    1
    peppermint oil and other natural flavor
  • Questions?

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

  • PRINCIPAL DISPLAY PANEL - 113 g Tube Carton

    THE ORIGINAL
    Tom's
    OF MAINE

    • NOT TESTED ON
    ANIMALS •

    NATURAL • WITH FLUORIDE

    WHOLE
    CARE®

    anticavity toothpaste

    PEPPERMINT

    STRENGTHENS ENAMEL

    PREVENTS CAVITIES

    WHITENS TEETH*

    NO
    ANIMAL TESTING,
    ARTIFICIAL FLAVORS,
    SWEETENERS OR DYES

    4.0 OZ (113 g)

    PRINCIPAL DISPLAY PANEL - 113 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    TOM WHOLE CARE PEPPERMINT   FIGHTS CAVITIES WHITENING FRESH BREATH HELPS FIGHT TARTAR
    sodium monofluorophosphate paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51009-202
    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)  
    Water (UNII: 059QF0KO0R)  
    Calcium carbonate (UNII: H0G9379FGK)  
    Hydrated Silica (UNII: Y6O7T4G8P9)  
    Xylitol (UNII: VCQ006KQ1E)  
    Peppermint Oil (UNII: AV092KU4JH)  
    Sodium Lauryl Sulfate (UNII: 368GB5141J)  
    Carrageenan (UNII: 5C69YCD2YJ)  
    Zinc citrate (UNII: K72I3DEX9B)  
    Sodium Bicarbonate (UNII: 8MDF5V39QO)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    Product Characteristics
    ColorWHITE (Off white) Score    
    ShapeSize
    FlavorPEPPERMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51009-202-471 in 1 CARTON06/06/2014
    1133 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:51009-202-041 in 1 CARTON10/29/2018
    2113 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph drugM02106/06/2014
    Labeler - Tom's of Maine, Inc. (052764354)
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