Label: COLGATE OPTIC WHITE RENEWAL HIGH IMPACT WHITE- sodium monofluorophosphate paste, dentifrice

  • NDC Code(s): 35000-982-15, 35000-982-41, 35000-982-43, 35000-982-62, view more
    35000-982-63
  • 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 October 30, 2019

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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, Flavor, Sodium Lauryl Sulfate, Tetrasodium Pyrophosphate, Sodium Saccharin, Disodium Pyrophosphate, 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 - 85 g Tube Carton

    Colgate®
    Anticavity Fluoride Toothpaste

    NEW

    OPTIC
    WHITE®

    RENEWAL

    REMOVES
    10 YEARS OF
    YELLOW STAINS*

    HYDROGEN
    3%
    PEROXIDE

    HIGH IMPACT WHITE

    NET WT 3.0 OZ (85 g)

    ENAMEL SAFE

    PRINCIPAL DISPLAY PANEL - 85 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    COLGATE OPTIC WHITE RENEWAL HIGH IMPACT WHITE 
    sodium monofluorophosphate paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35000-982
    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:35000-982-631 in 1 CARTON11/04/2019
    185 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:35000-982-622 in 1 CARTON11/04/2019
    285 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:35000-982-151 in 1 CARTON12/13/2019
    320 g in 1 TUBE; Type 0: Not a Combination Product
    4NDC:35000-982-411 in 1 CARTON03/13/2020
    4116 g in 1 TUBE; Type 0: Not a Combination Product
    5NDC:35000-982-431 in 1 CARTON04/04/2022
    5121 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35511/04/2019
    Labeler - Colgate-Palmolive Company (001344381)
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