Label: SEA SALT ANTICAVITY SALT47 GENTLY SCRUBS AWAY SURFACE STAINS / FIGHTS BAD BREATH GERMS / STRENGTHENS ENAMEL- sodium fluoride 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 August 30, 2019

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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, sodium chloride, sodium lauryl sulfate, zinc citrate, natural flavor1, xanthan gum, carrageenan.

    1
    peppermint oil and other natural flavor
  • Questions?

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

  • PRINCIPAL DISPLAY PANEL - 133 g Tube Carton

    4.7 OZ (133 g)

    SINCE 1970
    Tom's®
    OF MAINE

    natural
    with fluoride

    SEA SALT

    anticavity toothpaste

    gently scrubs away surface stains
    fights bad breath germs
    strengthens enamel

    refreshing mint

    with
    purified
    sea salt

    PRINCIPAL DISPLAY PANEL - 133 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    SEA SALT ANTICAVITY SALT47   GENTLY SCRUBS AWAY SURFACE STAINS / FIGHTS BAD BREATH GERMS / STRENGTHENS ENAMEL
    sodium fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51009-901
    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
    Water (UNII: 059QF0KO0R)  
    Sorbitol (UNII: 506T60A25R)  
    Hydrated Silica (UNII: Y6O7T4G8P9)  
    Xylitol (UNII: VCQ006KQ1E)  
    Glycerin (UNII: PDC6A3C0OX)  
    Sodium Chloride (UNII: 451W47IQ8X)  
    Sodium Lauryl Sulfate (UNII: 368GB5141J)  
    Zinc Citrate (UNII: K72I3DEX9B)  
    Peppermint Oil (UNII: AV092KU4JH)  
    Xanthan Gum (UNII: TTV12P4NEE)  
    Carrageenan (UNII: 5C69YCD2YJ)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorPEPPERMINT (Refreshing Mint) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51009-901-471 in 1 CARTON11/12/2018
    1133 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35511/12/2018
    Labeler - Toms of Maine, Inc. (052764354)
    Establishment
    NameAddressID/FEIBusiness Operations
    Toms of Maine, Inc.829517189MANUFACTURE(51009-901)
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