Label: CAVITY PROTECTION- sodium monofluorophosphate paste, dentifrice
CAVITY PROTECTION- sodium monofluorophosphate paste, dentifrice

  • Category: HUMAN OTC DRUG LABEL

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Drug Label Information

Updated May 10, 2011

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Sodium monofluorophosphate 0.76% (0.15% 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

    calcium carbonate, water, glycerin, sodium bicarbonate, Chondrus crispus (carrageenan), Mentha piperita (peppermint) oil, xylitol, 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 - 155.9 g Carton

    SINCE 1970
    Tom's
    OF MAINE    ™

    baking soda ∣ natural

    CAVITY PROTECTION

    fights cavities ∣ fresh breath

    fluoride toothpaste

    peppermint

    ADA
    Accepted
    American
    Dental
    Association ®

    NET WT 5.5 OZ (155.9 g)

    Principal Display Panel - 155.9 g Carton
  • PRINCIPAL DISPLAY PANEL - 155.9 g Carton

    SINCE 1970
    Tom's
    OF MAINE    ™

    natural

    CAVITY PROTECTION

    fights cavities ∣ fresh breath

    fluoride toothpaste

    spearmint

    ADA
    Accepted
    American
    Dental
    Association ®

    NET WT 5.5 OZ (155.9 g)

    Principal Display Panel - 155.9 g Carton
  • INGREDIENTS AND APPEARANCE
    CAVITY PROTECTION   PEPPERMINT WITH BAKING SODA
    sodium monofluorophosphate paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51009-120
    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
    Calcium carbonate (UNII: H0G9379FGK)  
    Glycerin (UNII: PDC6A3C0OX)  
    Water (UNII: 059QF0KO0R)  
    Sodium Bicarbonate (UNII: 8MDF5V39QO)  
    Carrageenan (UNII: 5C69YCD2YJ)  
    Xylitol (UNII: VCQ006KQ1E)  
    Sodium Lauryl Sulfate (UNII: 368GB5141J)  
    Peppermint oil (UNII: AV092KU4JH)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorPEPPERMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51009-120-551 in 1 CARTON
    1155.9 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35502/14/2011
    CAVITY PROTECTION   SPEARMINT
    sodium monofluorophosphate paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51009-116
    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
    Calcium carbonate (UNII: H0G9379FGK)  
    Glycerin (UNII: PDC6A3C0OX)  
    Water (UNII: 059QF0KO0R)  
    Xylitol (UNII: VCQ006KQ1E)  
    Carrageenan (UNII: 5C69YCD2YJ)  
    Sodium Lauryl Sulfate (UNII: 368GB5141J)  
    Spearmint Oil (UNII: C3M81465G5)  
    Peppermint oil (UNII: AV092KU4JH)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorSPEARMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51009-116-551 in 1 CARTON
    1155.9 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35502/14/2011
    Labeler - Tom's of Maine, Inc. (052764354)
    Establishment
    NameAddressID/FEIBusiness Operations
    Tom's of Maine, Inc.052764354MANUFACTURE
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