WICKED COOL FLUORIDE TWEEN MILD MINT LMFT (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [TOM'S OF MAINE]

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  • WICKED COOL FLUORIDE TWEEN MILD MINT LMFT (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [TOM'S OF MAINE]

WICKED COOL FLUORIDE TWEEN MILD MINT LMFT (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [TOM'S OF MAINE]
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NDC 51009-812-42
Set ID 6a1099d5-f30c-47fd-a4fd-aa443730f41d
Category HUMAN OTC DRUG LABEL
Packager Tom's of Maine
Generic Name
Product Class
Product Number
Application Number PART355
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Sodium monofluorophosphate 0.76% (0.13% 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, calcium carbonate, hydrated silica, carrageenan, sodium lauryl sulfate, natural flavor1

    1
    peppermint oil and other natural flavor
  • Questions?

    1-800-FOR-TOMS (1-800-367-8667)

  • PRINCIPAL DISPLAY PANEL - 119 g Tube Label

    SINCE 1970
    Tom's
    OF MAINE®

    ADA
    Accepted
    American
    Dental
    Association®

    natural
    Wicked
    cool!™

    fluoride
    toothpaste

    mild mint

    made
    for kids
    8+

    fights cavities
    strengthens enamel
    freshens breath
    dye free

    NET WT 4.2 OZ (119 g)

    PRINCIPAL DISPLAY PANEL - 119 g Tube Label
  • INGREDIENTS AND APPEARANCE
    WICKED COOL FLUORIDE TWEEN MILD MINT LMFT 
    sodium monofluorophosphate paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51009-812
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Sodium monofluorophosphate (UNII: C810JCZ56Q) (Fluoride ion - UNII:Q80VPU408O) Fluoride ion0.00243 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Glycerin (UNII: PDC6A3C0OX)  
    Water (UNII: 059QF0KO0R)  
    Calcium Carbonate (UNII: H0G9379FGK)  
    hydrated silica (UNII: Y6O7T4G8P9)  
    carrageenan (UNII: 5C69YCD2YJ)  
    sodium lauryl sulfate (UNII: 368GB5141J)  
    Peppermint Oil (UNII: AV092KU4JH)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorPEPPERMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51009-812-42119 g in 1 TUBE; Type 0: Not a Combination Product10/19/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35510/19/2012
    Labeler - Tom's of Maine (052764354)
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