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

  • NDC Code(s): 35000-893-41, 35000-893-43
  • Packager: Colgate-Palmolive Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 17, 2024

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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 CARTON01/07/202212/31/2024
    1121 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:35000-893-411 in 1 CARTON01/07/2022
    2116 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH DRUGM02101/07/2022
    Labeler - Colgate-Palmolive Company (001344381)
    Registrant - Mission Hills, S.A. de C.V. (812312122)
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