Label: SIMPLY WHITE SWEET MINT- sodium fluoride paste, dentifrice

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 18, 2024

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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, Chondrus crispus (carrageenan).

  • Questions?

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

  • PRINCIPAL DISPLAY PANEL - 133.2g Tube Carton

    new!

    SINCE 1970
    Tom's
    OF MAINE    ™

    natural

    SIMPLY WHITE®

    whitening | cavity protection | fresh breath

    fluoride toothpaste

    sweet mint gel

    NET WT 133.2g (4.7 OZ)

    PRINCIPAL DISPLAY PANEL - 133.2g Tube Carton
  • INGREDIENTS AND APPEARANCE
    SIMPLY WHITE  SWEET MINT
    sodium fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51009-149
    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, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    CARRAGEENAN (UNII: 5C69YCD2YJ)  
    ANISE (UNII: 21C2F5E8RE)  
    VANILLIN (UNII: CHI530446X)  
    CLOVE OIL (UNII: 578389D6D0)  
    ZINGERONE (UNII: 4MMW850892)  
    PIPERONAL (UNII: KE109YAK00)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorMINT (Sweet Mint) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51009-149-061 in 1 CARTON03/12/201012/30/2025
    1133.2 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH DRUGM02103/12/201012/30/2025
    Labeler - Tom's of Maine, Inc. (052764354)
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