Label: MAXIMUM STRENGTH SENSITIVE TRUE MINT- sodium fluoride and potassium nitrate paste, dentifrice

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 September 12, 2019

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    Potassium nitrate 5%Tooth desensitizer
    Sodium fluoride 0.24% (0.15 w/v fluoride ion)Anticavity
  • Uses

    • builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact
    • helps protect against cavities
  • Warnings

    When using this product, do not use longer than 4 weeks unless recommended by a dentist or physician.

    Stop use and ask a dentist if the problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist.

    Keep out of reach of children. 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 12 years of age and older apply at least a 1-inch strip of the product onto a soft bristle toothbrush. Brush teeth thoroughly at least 1 minute twice a day (morning and evening) or as recommended by a dentist or physician. Make sure to brush all sensitive areas of the teeth.
    • children under 12 years of age: consult a dentist or physician
  • Inactive ingredients

    Sorbitol, hydrated silica, xylitol, water, glycerin, organic Aloe barbadensis leaf juice, Mentha piperita (peppermint) oil and other natural flavors, cocamidopropyl betaine, xanthan gum, titanium dioxide.

  • Questions?

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

  • SPL UNCLASSIFIED SECTION

    © 2010 Tom's of Maine, Inc.
    302 Lafayette Ctr.
    Kennebunk, ME 04043

  • PRINCIPAL DISPLAY PANEL - 113 g Box

    SINCE 1970
    Tom's
    OF MAINE™

    maximum strength* | natural

    SENSITIVE

    clinically proven to reduce painful sensitivity

    toothpaste for sensitive teeth
    and cavity prevention with fluoride

    true mint

    NET WT 4.0 OZ (113 g)

    Principal Display Panel - 113 g Box
  • INGREDIENTS AND APPEARANCE
    MAXIMUM STRENGTH SENSITIVE  TRUE MINT
    sodium fluoride and potassium nitrate paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51009-167
    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
    Potassium Nitrate (UNII: RU45X2JN0Z) (Nitrate Ion - UNII:T93E9Y2844) Potassium Nitrate0.05 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    sorbitol (UNII: 506T60A25R)  
    hydrated silica (UNII: Y6O7T4G8P9)  
    xylitol (UNII: VCQ006KQ1E)  
    glycerin (UNII: PDC6A3C0OX)  
    water (UNII: 059QF0KO0R)  
    aloe vera leaf (UNII: ZY81Z83H0X)  
    cocamidopropyl betaine (UNII: 5OCF3O11KX)  
    xanthan gum (UNII: TTV12P4NEE)  
    peppermint oil (UNII: AV092KU4JH)  
    titanium dioxide (UNII: 15FIX9V2JP)  
    spearmint oil (UNII: C3M81465G5)  
    menthol, unspecified form (UNII: L7T10EIP3A)  
    glycyrrhizin (UNII: 6FO62043WK)  
    Anise (UNII: 21C2F5E8RE)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorSPEARMINT (True Mint) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51009-167-041 in 1 BOX09/01/2009
    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 not finalpart35609/01/2009
    Labeler - Tom's of Maine, Inc. (052764354)
    Establishment
    NameAddressID/FEIBusiness Operations
    Tom's of Maine, Inc.829517189MANUFACTURE(51009-167)
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