Label: TOMS WHOLE CARE WINTERMINT FIGHTS CAVITIES / WHITENING / FRESH BREATH / HELPS FIGHT TARTAR / NO ARTIFICIAL DYES OR SWEETENERS- sodium monofluorophosphate paste, dentifrice

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated February 13, 2015

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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 - 133 g Tube Carton

    SINCE 1970
    Tom's®
    OF MAINE

    with fluoride | natural

    WHOLE CARE®

    fluoride toothpaste
    fights cavities | whitening | fresh breath | helps fight tartar
    no artificial dyes or sweeteners

    wintermint

    NET WT 4.7 OZ (133 g)

    Principal Display Panel - 133 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    TOMS WHOLE CARE WINTERMINT   FIGHTS CAVITIES / WHITENING / FRESH BREATH / HELPS FIGHT TARTAR / NO ARTIFICIAL DYES OR SWEETENERS
    sodium monofluorophosphate paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51009-212
    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
    WATER (UNII: 059QF0KO0R)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SORBITOL (UNII: 506T60A25R)  
    XYLITOL (UNII: VCQ006KQ1E)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    ZINC CITRATE (UNII: K72I3DEX9B)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    CARRAGEENAN (UNII: 5C69YCD2YJ)  
    Product Characteristics
    ColorWHITE (Off White) Score    
    ShapeSize
    FlavorWINTERGREEN (Wintermint) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51009-212-471 in 1 CARTON03/01/2015
    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 FINALpart35503/01/2015
    Labeler - Tom's of Maine, Inc. (052764354)
    Establishment
    NameAddressID/FEIBusiness Operations
    Tom's of Maine, Inc.829517189MANUFACTURE(51009-212)
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