Label: CHILDRENS OUTRAGEOUS ORANGE MANGO- 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 August 24, 2010

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Sodium monofluorophosphate 0.76% (0.13% 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 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

    glycerin, water, calcium carbonate, hydrated silica, natural flavors, Chondrus crispus (carrageenan), sodium lauryl sulfate.

  • Questions?

    1-800-FOR-TOMS (1-800-367-8667) M - F 8:30 a.m. - 5:30 p.m. ET

  • PRINCIPAL DISPLAY PANEL - 119 g Tube

    SINCE 1970
    Tom's    ™
    OF MAINE

    ADA
    Accepted
    American
    Dental
    Association ®

    natural
    children's

    prevents
    cavities

    tastes great

    fluoride toothpaste

    outrageous
    orange mango    ™

    NET WT 4.2 OZ (119 g)

    Principal Display Panel – 119 g Tube
  • INGREDIENTS AND APPEARANCE
    CHILDRENS  OUTRAGEOUS ORANGE MANGO
    sodium monofluorophosphate paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51009-127
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Sodium Monofluorophosphate (UNII: C810JCZ56Q) (fluoride ion - UNII:Q80VPU408O) Sodium Monofluorophosphate0.0076 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Glycerin (UNII: PDC6A3C0OX)  
    Water (UNII: 059QF0KO0R)  
    Calcium carbonate (UNII: H0G9379FGK)  
    Hydrated silica (UNII: Y6O7T4G8P9)  
    Orange (UNII: 5EVU04N5QU)  
    Carrageenan (UNII: 5C69YCD2YJ)  
    sodium lauryl sulfate (UNII: 368GB5141J)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorORANGE (Orange-mango with other natural fruit flavors) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51009-127-041 in 1 CARTON
    1113 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35508/30/2010
    CHILDRENS  OUTRAGEOUS ORANGE MANGO
    sodium monofluorophosphate paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51009-830
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Sodium Monofluorophosphate (UNII: C810JCZ56Q) (fluoride ion - UNII:Q80VPU408O) Sodium Monofluorophosphate0.0076 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Glycerin (UNII: PDC6A3C0OX)  
    Water (UNII: 059QF0KO0R)  
    Calcium carbonate (UNII: H0G9379FGK)  
    Hydrated silica (UNII: Y6O7T4G8P9)  
    Orange (UNII: 5EVU04N5QU)  
    Carrageenan (UNII: 5C69YCD2YJ)  
    sodium lauryl sulfate (UNII: 368GB5141J)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorORANGE (Orange-mango with other natural fruit flavors) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51009-830-94119 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35508/30/2010
    Labeler - Tom's of Maine, Inc. (052764354)
    Establishment
    NameAddressID/FEIBusiness Operations
    Tom's of Maine, Inc.052764354MANUFACTURE
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