Label: TOMS KIDS WATERMELON WIGGLE- sodium monofluorophosphate paste, dentifrice

  • NDC Code(s): 51009-854-42, 51009-854-51
  • 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 September 22, 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

    glycerin, water, calcium carbonate, hydrated silica, natural flavor, sodium lauryl sulfate, carrageenan, rebaudioside A, benzyl alcohol.

  • Questions?

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

  • PRINCIPAL DISPLAY PANEL - 144 g Tube Label

    THE ORIGINAL
    Tom's
    OF MAINE

    Kid's
    • NATURAL •

    fluoride
    anticavity toothpaste

    fights cavities
    tastes great • dye free

    ages
    2+

    WATERMELON WIGGLE

    NET WT
    5.1 OZ
    (144 g)

    BRUSH
    RECYCLE*
    SMILE

    PRINCIPAL DISPLAY PANEL - 144 g Tube Label
  • INGREDIENTS AND APPEARANCE
    TOMS KIDS WATERMELON WIGGLE 
    sodium monofluorophosphate paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51009-854
    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
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    CARRAGEENAN (UNII: 5C69YCD2YJ)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    REBAUDIOSIDE A (UNII: B3FUD0528F)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorWATERMELONImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51009-854-42119 g in 1 TUBE; Type 0: Not a Combination Product12/01/2023
    2NDC:51009-854-51144 g in 1 TUBE; Type 0: Not a Combination Product12/01/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35512/01/2023
    Labeler - Tom's of Maine, Inc. (052764354)
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