Label: PEPPERMINT CHARCOAL ANTICAVITY PCFT6 GENTLY WHITENS TEETH / FIGHTS CAVITIES / SAFE FOR ENAMEL / SAFE FOR EVERYDAY USE- sodium fluoride paste, dentifrice

  • NDC Code(s): 51009-900-40, 51009-900-47
  • 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 2, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Sodium fluoride 0.24% (0.15% 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

    water, sorbitol, hydrated silica, xylitol, glycerin, lauryl glucoside, disodium cocoyl glutamate, natural flavor1, benzyl alcohol, charcoal powder, xanthan gum, carrageenan, Rebaudioside A.

    1
    peppermint 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

    ACTIVATED
    CHARCOAL
    anticavity toothpaste

    WHITENS TEETH*

    GENTLY REMOVES
    SURFACE STAINS

    PREVENTS CAVITIES

    NO
    ANIMAL TESTING, SLS,
    ARTIFICIAL FLAVORS,
    SWEETENERS OR DYES

    PEPPERMINT

    4.0 OZ (113 g)

    PRINCIPAL DISPLAY PANEL - 113 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    PEPPERMINT CHARCOAL ANTICAVITY PCFT6   GENTLY WHITENS TEETH / FIGHTS CAVITIES / SAFE FOR ENAMEL / SAFE FOR EVERYDAY USE
    sodium fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51009-900
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.0024 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    XYLITOL (UNII: VCQ006KQ1E)  
    LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)  
    SODIUM COCOYL GLUTAMATE (UNII: BMT4RCZ3HG)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    ACTIVATED CHARCOAL (UNII: 2P3VWU3H10)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CARRAGEENAN (UNII: 5C69YCD2YJ)  
    REBAUDIOSIDE A (UNII: B3FUD0528F)  
    Product Characteristics
    ColorBLACKScore    
    ShapeSize
    FlavorPEPPERMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51009-900-471 in 1 CARTON12/18/2018
    1133 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:51009-900-401 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 FINALpart35512/18/2018
    Labeler - Tom's of Maine, Inc. (052764354)
    Registrant - Tom's of Maine, Inc. (829517189)
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