Label: CLEAN AND GENTLE- 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 February 14, 2011

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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 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, organic Aloe barbadensis (aloe) leaf juice, xylitol, Chondrus crispus (carrageenan), Acacia senegal (acacia) gum, glycyrrhizic acid, Mentha piperita (peppermint) oil.

  • Questions?

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

  • PRINCIPAL DISPLAY PANEL - 133 g Carton

    SINCE 1970
    Tom's
    OF MAINE    ™

    with fluoride | natural

    CLEAN & GENTLE

    SLS-free | anticavity | whitening | fresh breath
    fluoride toothpaste

    peppermint

    NET WT 4.7 OZ (133 g)

    Principal Display Panel - 133 g Carton
  • INGREDIENTS AND APPEARANCE
    CLEAN AND GENTLE   PEPPERMINT
    sodium monofluorophosphate paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51009-107
    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)  
    Xylitol (UNII: VCQ006KQ1E)  
    Carrageenan (UNII: 5C69YCD2YJ)  
    Peppermint Oil (UNII: AV092KU4JH)  
    Glycyrrhizin (UNII: 6FO62043WK)  
    Aloe Vera Leaf (UNII: ZY81Z83H0X)  
    Product Characteristics
    ColorWHITE (Off-white) Score    
    ShapeSize
    FlavorPEPPERMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51009-107-471 in 1 CARTON
    1133 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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