Label: TOMS FRESH AND BRIGHT- 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 September 19, 2023

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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

    water, sorbitol, hydrated silica, xylitol, glycerin, natural flavor, sodium lauryl sulfate, zinc citrate, xanthan gum, benzyl alcohol, carrageenan.

  • Questions?

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

  • PRINCIPAL DISPLAY PANEL - 113 g Tube Carton

    Certified
    B®
    Corporation

    NEW

    THE ORIGINAL
    Tom's
    OF MAINE

    NATURAL • WITH FLUORIDE

    FRESH +
    BRIGHT
    anticavity toothpaste

    HELPS FIGHT BAD
    BREATH BACTERIA

    pureactiv:
    SOLUTIONS

    FRESH MINT

    4.0 OZ (113 g)

    PRINCIPAL DISPLAY PANEL - 113 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    TOMS FRESH AND BRIGHT 
    sodium monofluorophosphate paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51009-919
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.1 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    XYLITOL (UNII: VCQ006KQ1E)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    ZINC CITRATE (UNII: K72I3DEX9B)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CARRAGEENAN (UNII: 5C69YCD2YJ)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51009-919-401 in 1 CARTON11/30/202112/30/2025
    1113 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35511/30/202112/30/2025
    Labeler - Tom's of Maine, Inc. (052764354)
    Registrant - Colgate-Palmolive Company (001344381)
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