Label: NATURAL FLUORIDE FRESH MINT CAVITY PROTECTION WHITENING FRESH BREATH- 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 13, 2022

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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, carrageenan.

    1
    Peppermint oil and other natural flavor
  • Questions?

    1-800-FOR-TOMS (1-800-367-8667) M - F 8:30 a.m. - 5 p.m. ET

  • PRINCIPAL DISPLAY PANEL - 85 g Tube

    SINCE 1970
    Tom's®
    OF MAINE

    natural
    fluoride
    TOOTHPASTE
    cavity protection | whitening | fresh breath

    fresh mint

    NET WT 3 OZ (85 g)

    Principal Display Panel
  • INGREDIENTS AND APPEARANCE
    NATURAL FLUORIDE FRESH MINT   CAVITY PROTECTION WHITENING FRESH BREATH
    sodium fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51009-238
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE0.00243 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    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
    FlavorMINT (Fresh Mint) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51009-238-5985 g in 1 TUBE; Type 0: Not a Combination Product09/01/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35509/01/2012
    Labeler - Tom's of Maine, Inc. (052764354)
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