Label: OUTRAGEOUS ORANGE ANTICAVITY - OFT51 MRT- 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 November 8, 2019

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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, benzyl alcohol, sodium lauryl sulfate, carrageenan, natural flavor, Citrus limon (Lemon) juice, Mangifera indica (Mango) juice, Citrus aurantium dulcis (Orange) juice, Ananas sativus (Pineapple) fruit juice, Fragaria ananassa (Strawberry) fruit juice.

  • Questions?

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

  • PRINCIPAL DISPLAY PANEL - 144 g Tube Label

    20% more!
    vs. 4.2oz size

    SINCE 1970
    Tom's
    OF MAINE®

    ADA
    Accepted
    American
    Dental
    Association ®

    natural
    children's

    fluoride toothpaste

    fights cavities
    tastes great
    dye free

    with real
    fruit juice!

    outrageous
    orange mango

    NET WT 5.1 OZ (144 g)

    PRINCIPAL DISPLAY PANEL - 144 g Tube Label
  • INGREDIENTS AND APPEARANCE
    OUTRAGEOUS ORANGE ANTICAVITY - OFT51 MRT 
    sodium monofluorophosphate paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51009-911
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.0014 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARRAGEENAN (UNII: 5C69YCD2YJ)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    ORANGE (UNII: 5EVU04N5QU)  
    LEMON JUICE (UNII: AGN709ANTJ)  
    MANGO JUICE (UNII: IU6I1JNV24)  
    ORANGE JUICE (UNII: 5A9KE2L9L3)  
    PINEAPPLE JUICE (UNII: O4KOG0B1KC)  
    STRAWBERRY JUICE (UNII: U8NS58UGW0)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorORANGE (Orange Mango) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51009-911-51144 g in 1 TUBE; Type 0: Not a Combination Product11/15/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35511/15/2019
    Labeler - Tom's of Maine, Inc. (052764354)
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