Label: COLGATE OPTIC WHITE SPARKLING- sodium monofluorophosphate paste, dentifrice

  • NDC Code(s): 35000-758-94
  • Packager: Colgate-Palmolive Company
  • 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 August 1, 2022

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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, PEG/PPG-116/66 Copolymer, PEG-12, Glycerin, PVP, Silica, Flavor, Tetrasodium Pyrophosphate, Sodium Lauryl Sulfate, Hydrogen Peroxide, Disodium Pyrophosphate, Sodium Saccharin, Sucralose, BHT.

  • Questions?

    1-800-468-6502

  • SPL UNCLASSIFIED SECTION

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

  • PRINCIPAL DISPLAY PANEL - 130 g Tube Carton

    Colgate®
    Anticavity Fluoride Toothpaste

    OPTIC
    WHITE®

    LOVERS

    REMOVES STUBBORN,
    DARK STAINS

    DEEPLY WHITENS
    BEYOND THE SURFACE

    FRESH MINT

    NET WT 4.6 OZ (130 g)
    ENAMEL SAFE

    PRINCIPAL DISPLAY PANEL - 130 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    COLGATE OPTIC WHITE SPARKLING 
    sodium monofluorophosphate paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35000-758
    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)  
    CALCIUM PYROPHOSPHATE (UNII: X69NU20D19)  
    PEG/PPG-116/66 COPOLYMER (UNII: JP0CK963E0)  
    POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POVIDONE K15 (UNII: E54VE15114)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
    SODIUM ACID PYROPHOSPHATE (UNII: H5WVD9LZUD)  
    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:35000-758-941 in 1 CARTON07/27/2022
    1130 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35507/27/2022
    Labeler - Colgate-Palmolive Company (001344381)
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