Label: LONG-LASTING WICKED FRESH - COOL PEPPERMINT- 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 November 9, 2009

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Sodium monofluorophosphate 0.76% (0.14% w/v fluoride ion)

  • Purpose

    Anticavity

  • Use

    aids in the prevention of dental cavities.

  • Warnings

    Keep out of the 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 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

    glycerin, water, hydrated silica, calcium carbonate, xylitol, natural flavors, sodium lauryl sulfate, Chondrus crispus (carrageenan), Glycyrrhiza uralensis (licorice) root extract.

  • Questions?

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

  • SPL UNCLASSIFIED SECTION

    © 2009 Tom's of Maine, Inc., 302 Lafayette Ctr.,
    Kennebunk, ME 04043 Made in U.S.A.

  • PRINCIPAL DISPLAY PANEL - 147.4g Box

    cool peppermint

    new!

    natural
    care
    Tom's
    of Maine®

    LONG-LASTING
    wicked fresh!

    fresh breath anticavity toothpaste
    with fluoride

    NET WT 147.4g (5.2 OZ)

    Principal Display Panel - 147.4g Box
  • INGREDIENTS AND APPEARANCE
    LONG-LASTING WICKED FRESH - COOL PEPPERMINT 
    sodium monofluorophosphate paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51009-146
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Sodium monofluorophosphate (UNII: C810JCZ56Q) (Sodium cation - UNII:LYR4M0NH37) Sodium monofluorophosphate0.0076  g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Glycerin (UNII: PDC6A3C0OX)  
    Water (UNII: 059QF0KO0R)  
    Calcium carbonate (UNII: H0G9379FGK)  
    Xylitol (UNII: VCQ006KQ1E)  
    Silicon Dioxide (UNII: ETJ7Z6XBU4)  
    Carrageenan (UNII: 5C69YCD2YJ)  
    Peppermint Oil (UNII: AV092KU4JH)  
    Menthol (UNII: L7T10EIP3A)  
    Sodium Lauryl Sulfate (UNII: 368GB5141J)  
    Anise Seed (UNII: 21C2F5E8RE)  
    Eucalyptus Oil (UNII: 2R04ONI662)  
    Licorice (UNII: 61ZBX54883)  
    Vanillin (UNII: CHI530446X)  
    Cinnamyl Alcohol (UNII: SS8YOP444F)  
    Clove oil (UNII: 578389D6D0)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorPEPPERMINT (Cool Peppermint) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51009-146-061 in 1 BOX
    1147.4 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart33511/30/2009
    Labeler - Tom's of Maine, Inc. (052764354)
    Establishment
    NameAddressID/FEIBusiness Operations
    Tom's of Maine, Inc.052764354MANUFACTURE
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