Label: COLGATE OPTIC WHITE PLATINUM COOL 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 October 14, 2013

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  • 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 older: Brush 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 years: Use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing).
    • Children under 2 years: Ask 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
    www.colgateopticwhite.com

  • SPL UNCLASSIFIED SECTION

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

  • PRINCIPAL DISPLAY PANEL - 96 g Tube Label

    Colgate®

    OPTIC
    WHITE    ®
    PLATINUM

    WHITEN
    & PROTECT

    WHITESEAL™ TECHNOLOGY

    ANTICAVITY
    FLUORIDE TOOTHPASTE

    ENAMEL SAFE

    COOL MINT

    NET WT 3.4 OZ (96 g)

    PRINCIPAL DISPLAY PANEL - 96 g Tube Label
  • INGREDIENTS AND APPEARANCE
    COLGATE OPTIC WHITE PLATINUM   COOL MINT
    sodium monofluorophosphate paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65954-588
    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
    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:65954-588-931 in 1 CARTON
    196 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35511/18/2013
    Labeler - Mission Hills S.A de C.V (812312122)
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