Label: COLGATE OPTIC WHITE STAIN PREVENTION- sodium monofluorophosphate paste, dentifrice

  • NDC Code(s): 35000-893-43
  • Packager: Colgate-Palmolive Company
  • Category: HUMAN OTC DRUG LABEL

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 January 25, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Sodium Monofluorophosphate 0.76% (0.12% 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, PVP, PEG/PPG-116/66 Copolymer, Hydrogen Peroxide (3% w/v), Flavor, Sodium Lauryl Sulfate, Tetrasodium Pyrophosphate, Disodium Pyrophosphate, Sodium Saccharin, Silica, 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 - 121 g Tube Carton

    Colgate®
    Anticavity Fluoride Toothpaste

    OPTIC
    WHITE®
    RENEWAL

    10x
    WHITER TEETH*

    3%
    HYDROGEN
    PEROXIDE

    STAIN PREVENTION

    NET WT 4.3 OZ (121 g)
    ENAMEL SAFE

    Principal Display Panel - 121 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    COLGATE OPTIC WHITE STAIN PREVENTION 
    sodium monofluorophosphate paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35000-893
    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) 527 mg  in 1 g
    CALCIUM PYROPHOSPHATE (UNII: X69NU20D19)  
    POVIDONE K15 (UNII: E54VE15114)  
    PEG/PPG-116/66 COPOLYMER (UNII: JP0CK963E0)  
    HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM ACID PYROPHOSPHATE (UNII: H5WVD9LZUD)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:35000-893-431 in 1 CARTON01/07/2022
    1121 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35501/07/2022
    Labeler - Colgate-Palmolive Company (001344381)
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