Label: SIMPLY WHITE CLEAN MINT- 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 February 3, 2011

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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 the 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 older:brush 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

    hydrated silica, water, sorbitol, glycerin, xylitol, sodium lauryl sulfate, natural flavors, xanthan gum, titanium dioxide, Chondrus crispus (carrageenan).

  • Questions?

    1-800-FOR-TOMS M-F 8:30 a.m.-5 p.m. ET

  • SPL UNCLASSIFIED SECTION

    © 2010 Tom's of Maine, Inc., 302 Lafayette Ctr., Kennebunk, ME 04043
    Made in U.S.A.

  • PRINCIPAL DISPLAY PANEL - 133.2g Tube Carton

    new!

    SINCE 1970
    Tom's
    OF MAINE™

    natural

    SIMPLY WHITE®
    whitening | cavity protection | fresh breath
    fluoride toothpaste
    clean mint

    NET WT 133.2g (4.7 OZ)

    Principal Display Panel - 133.2g Tube Carton
  • INGREDIENTS AND APPEARANCE
    SIMPLY WHITE  CLEAN MINT
    sodium fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51009-148
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Sodium fluoride (UNII: 8ZYQ1474W7) (fluoride ion - UNII:Q80VPU408O) Sodium fluoride0.0024 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Sorbitol (UNII: 506T60A25R)  
    Water (UNII: 059QF0KO0R)  
    Silicon Dioxide (UNII: ETJ7Z6XBU4)  
    Glycerin (UNII: PDC6A3C0OX)  
    Xylitol (UNII: VCQ006KQ1E)  
    Sodium lauryl sulfate (UNII: 368GB5141J)  
    Menthol (UNII: L7T10EIP3A)  
    Xanthan gum (UNII: TTV12P4NEE)  
    Peppermint oil (UNII: AV092KU4JH)  
    Carrageenan (UNII: 5C69YCD2YJ)  
    Spearmint oil (UNII: C3M81465G5)  
    Titanium dioxide (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorMINT (Clean Mint) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51009-148-471 in 1 CARTON
    1133.2 g in 1 TUBE
    2NDC:51009-148-011 in 1 CARTON
    225 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35502/04/2011
    Labeler - Tom's of Maine, Inc. (052764354)
    Establishment
    NameAddressID/FEIBusiness Operations
    Tom's of Maine, Inc.052764354MANUFACTURE
    Establishment
    NameAddressID/FEIBusiness Operations
    Colgate-Palmolive Canada, Inc.259157246MANUFACTURE
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