Label: COLGATE OPTIC WHITE DUAL ACTION CRYSTAL MINT- 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 June 28, 2013

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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 contact a Poison Control Center right away.

  • Directions

    adults and children 2 years of age and olderbrush teeth thoroughly for 2 minutes, 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 pyrophosphate, propylene glycol, PEG/PPG-116/66 copolymer, PEG-12, glycerin, PVP, flavor, sodium lauryl sulfate, tetrasodium pyrophosphate, silica, hydrogen peroxide, sodium saccharin, phosphoric acid, disodium pyrophosphate, sucralose, butylated hydroxytoluene, water

  • Questions?

    1-800-468-6502

  • SPL UNCLASSIFIED SECTION

    Dist. by:
    COLGATE-PALMOLIVE COMPANY
    New York, NY 10022

  • PRINCIPAL DISPLAY PANEL - 116 g Tube Carton

    Colgate®

    WHITENS MORE THAN 3 SHADES*

    1 2 3 +

    RESULTS START IN 1 WEEK

    DAILY ANTICAVITY FLUORIDE TOOTHPASTE | ENAMEL SAFE

    NET WT 4.1 OZ (116 g)

    NEW

    OPTIC
    WHITE®

    DUAL ACTION
    SHINES & WHITENS

    CRYSTAL MINT

    Principal Display Panel - 116 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    COLGATE OPTIC WHITE DUAL ACTION CRYSTAL MINT 
    sodium monofluorophosphate paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65954-563
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CALCIUM PYROPHOSPHATE (UNII: X69NU20D19) 351.1 mg  in 1 g
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POVIDONE K15 (UNII: E54VE15114)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    PHOSPHORIC ACID (UNII: E4GA8884NN)  
    SODIUM ACID PYROPHOSPHATE (UNII: H5WVD9LZUD)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65954-563-411 in 1 CARTON
    1116 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35512/20/2012
    Labeler - Mission Hills S.A de C.V (812312122)
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