Label: TOMS LUMINOUS WHITE FLUORIDE CLEAN MINT CAVITY PROTECTION / WHITENING- sodium fluoride paste, dentifrice

  • NDC Code(s): 51009-218-21, 51009-218-40, 51009-218-75
  • Packager: Tom's of Maine, Inc.
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated October 26, 2023

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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 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

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

    1
    peppermint oil and other natural flavor
  • PRINCIPAL DISPLAY PANEL - 113 g Tube Label

    THE ORIGINAL
    Tom's
    OF MAINE

    BEAUTIFUL SMILE.
    BEAUTIFUL PLANET.

    LUMINOUS
    WHITE

    4.0 OZ (113 g)

    PRINCIPAL DISPLAY PANEL - 113 g Tube Label
  • INGREDIENTS AND APPEARANCE
    TOMS LUMINOUS WHITE FLUORIDE CLEAN MINT   CAVITY PROTECTION / WHITENING
    sodium fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51009-218
    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)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SORBITOL (UNII: 506T60A25R)  
    XYLITOL (UNII: VCQ006KQ1E)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    CARRAGEENAN (UNII: 5C69YCD2YJ)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorPEPPERMINT (Clean Mint) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51009-218-751 in 1 CARTON10/20/201712/29/2023
    121 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:51009-218-401 in 1 CARTON11/13/2018
    2113 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:51009-218-2121 g in 1 TUBE; Type 0: Not a Combination Product07/25/201811/03/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph drugM02112/01/2015
    Labeler - Tom's of Maine, Inc. (052764354)
    Registrant - Tom's of Maine, Inc. (829517189)
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