Label: TOMS NATURAL ENAMEL STRENGTH PEPPERMINT STRENGTHENS ENAMEL / WHITENING / FIGHTS CAVITIES / FRESHENS BREATH / NO ARTIFICIAL DYES OR SWEETENERS- sodium fluoride 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 December 4, 2014

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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

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

    1
    peppermint 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

    ADA
    Accepted
    American
    Dental
    Association ®

    with fluoride
    natural

    ENAMEL STRENGTH®

    fluoride toothpaste

    strengthens enamel | whitening
    fights cavities | freshens breath
    no artificial dyes or sweeteners

    peppermint

    NET WT 4.0 OZ (113 g)

    PRINCIPAL DISPLAY PANEL - 113 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    TOMS NATURAL ENAMEL STRENGTH PEPPERMINT   STRENGTHENS ENAMEL / WHITENING / FIGHTS CAVITIES / FRESHENS BREATH / NO ARTIFICIAL DYES OR SWEETENERS
    sodium fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51009-209
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.00243 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    XYLITOL (UNII: VCQ006KQ1E)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    CARRAGEENAN (UNII: 5C69YCD2YJ)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorPEPPERMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51009-209-401 in 1 CARTON12/17/2014
    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 FINALpart35512/17/2014
    Labeler - Tom's of Maine, Inc. (052764354)
    Establishment
    NameAddressID/FEIBusiness Operations
    Tom's of Maine, Inc.829517189MANUFACTURE(51009-209)
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