Label: COLGATE OPTIC WHITE PLATINUM ANTICAVITY FLUORIDE- sodium monofluorophosphate paste, dentifrice

  • NDC Code(s): 35000-952-86, 35000-952-93
  • Packager: Colgate-Palmolive Company
  • Category: HUMAN OTC DRUG LABEL

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Drug Label Information

Updated December 12, 2019

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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 contact a Poison Control Center right away.

  • 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

    propylene glycol, calcium pyrophosphate, glycerin, PEG/PPG-116/66 copolymer, PEG-12, PVP, silica, flavor, sodium lauryl sulfate, tetrasodium pyrophosphate, disodium pyrophosphate, hydrogen peroxide, sodium saccharin, sucralose, BHT

  • Questions?

    1-800-468-6502

  • SPL UNCLASSIFIED SECTION

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

  • PRINCIPAL DISPLAY PANEL - 96 g Tube Carton

    Colgate®

    OPTIC
    WHITE
    ®
    PLATINUM™
    ANTICAVITY FLUORIDE TOOTHPASTE

    LASTING
    WHITE™

    WHITENS AND SEALS
    OUT EVEN TOUGH STAINS*

    with WHITESEAL™ TECHNOLOGY

    ENAMEL SAFE

    COOL MINT

    NET WT 3.4 OZ (96 g)

    PRINCIPAL DISPLAY PANEL - 96 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    COLGATE OPTIC WHITE PLATINUM ANTICAVITY FLUORIDE 
    sodium monofluorophosphate paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35000-952
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.1 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 338.1 mg  in 1 g
    CALCIUM PYROPHOSPHATE (UNII: X69NU20D19)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PEG/PPG-116/66 COPOLYMER (UNII: JP0CK963E0)  
    POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)  
    POVIDONE K15 (UNII: E54VE15114)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
    SODIUM ACID PYROPHOSPHATE (UNII: H5WVD9LZUD)  
    HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:35000-952-931 in 1 CARTON07/01/2015
    196 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:35000-952-861 in 1 CARTON07/01/2015
    2127 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35507/01/2015
    Labeler - Colgate-Palmolive Company (001344381)