Label: LONG-LASTING WICKED FRESH - COOL PEPPERMINT- sodium monofluorophosphate paste, dentifrice
LONG-LASTING WICKED FRESH - SPEARMINT ICE- 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 May 9, 2011

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Sodium monofluorophosphate 0.76% (0.14% 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

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

  • Questions?

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

  • PRINCIPAL DISPLAY PANEL - 133 g Carton

    SINCE 1970
    Tom's
    OF MAINE    ™

    long-lasting | natural

    WICKED FRESH!™

    cavity protection | fresh breath

    fluoride toothpaste

    cool peppermint

    NET WT 4.7 OZ (133 g)

    Principal Display Panel - 133 g Carton
  • PRINCIPAL DISPLAY PANEL - 133 g Carton

    SINCE 1970
    Tom's
    OF MAINE    ™

    long-lasting | natural

    WICKED FRESH!™

    cavity protection | fresh breath

    fluoride toothpaste

    spearmint ice

    NET WT 4.7 OZ (133 g)

    Principal Display Panel - 133 g Carton
  • 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) (Fluoride Ion - UNII:Q80VPU408O) Sodium monofluorophosphate.0076 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Glycerin (UNII: PDC6A3C0OX)  
    Water (UNII: 059QF0KO0R)  
    Calcium carbonate (UNII: H0G9379FGK)  
    Xylitol (UNII: VCQ006KQ1E)  
    Hydrated Silica (UNII: Y6O7T4G8P9)  
    Carrageenan (UNII: 5C69YCD2YJ)  
    Sodium Lauryl Sulfate (UNII: 368GB5141J)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorPEPPERMINT (Cool Peppermint) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51009-146-471 in 1 CARTON
    1133 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35505/06/2011
    LONG-LASTING WICKED FRESH - SPEARMINT ICE 
    sodium monofluorophosphate paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51009-145
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Sodium monofluorophosphate (UNII: C810JCZ56Q) (Fluoride Ion - UNII:Q80VPU408O) Sodium monofluorophosphate.0076 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Glycerin (UNII: PDC6A3C0OX)  
    Water (UNII: 059QF0KO0R)  
    Calcium carbonate (UNII: H0G9379FGK)  
    Xylitol (UNII: VCQ006KQ1E)  
    Hydrated Silica (UNII: Y6O7T4G8P9)  
    Carrageenan (UNII: 5C69YCD2YJ)  
    Sodium Lauryl Sulfate (UNII: 368GB5141J)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorSPEARMINT (Spearmint Ice) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51009-145-471 in 1 CARTON
    1133 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35505/06/2011
    Labeler - Tom's of Maine, Inc. (052764354)
    Establishment
    NameAddressID/FEIBusiness Operations
    Tom's of Maine, Inc.052764354MANUFACTURE
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