Label: TOMS WICKED FRESH SPEARMINT ICE FRESH BREATH / CAVITY PROTECTION- sodium monofluorophosphate paste, dentifrice

  • NDC Code(s): 51009-206-40, 51009-206-47
  • Packager: Tom's of Maine, Inc.
  • 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 October 4, 2023

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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, xylitol, hydrated silica, sodium lauryl sulfate, natural flavor1, carrageenan, benzyl alcohol, Glycyrrhiza glabra (Licorice) root extract.

    1
    spearmint oil and other natural flavor
  • Questions?

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

  • PRINCIPAL DISPLAY PANEL - 113 g Tube Carton

    THE ORIGINAL
    Tom's
    OF MAINE

    NOT TESTED ON
    • ANIMALS •

    NATURAL • WITH FLUORIDE

    WICKED
    FRESH!®

    anticavity toothpaste

    SPEARMINT ICE

    4.0 OZ (113 g)

    CLINICALLY PROVEN
    TO FRESHEN BREATH

    FIGHTS CAVITIES

    BLOCKS BAD BREATH

    NO
    ANIMAL TESTING,
    ARTIFICIAL FLAVORS,
    SWEETENERS OR DYES

    Principal Display Panel - 113 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    TOMS WICKED FRESH SPEARMINT ICE   FRESH BREATH / CAVITY PROTECTION
    sodium monofluorophosphate paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51009-206
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.4 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    XYLITOL (UNII: VCQ006KQ1E)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    CARRAGEENAN (UNII: 5C69YCD2YJ)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    LICORICE (UNII: 61ZBX54883)  
    Product Characteristics
    ColorWHITE (Off white) Score    
    ShapeSize
    FlavorSPEARMINT (Spearmint Ice) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51009-206-471 in 1 CARTON06/06/2014
    1133 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:51009-206-401 in 1 CARTON09/30/2023
    2113 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35506/06/2014
    Labeler - Tom's of Maine, Inc. (052764354)
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