Label: COLGATE OPTIC WHITE PROSERIES ENAMEL STRENGHT- sodium monofluorophosphate paste, dentifrice

  • NDC Code(s): 35000-748-21, 35000-748-30
  • 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 October 31, 2019

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  • Active ingredient

    Sodium Monofluorophosphate 1.14% (0.19% 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 6 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician.
    • Children 6 to 12 years: Use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing).
    • Children under 6 years: Do not use unless directed by a dentist or physician.
  • Inactive ingredients

    Poloxamer 105, PVP, Calcium Pyrophosphate, PEG/PPG-116/66 Copolymer, Hydrogen Peroxide (5% w/v), Silica, Flavor, Sodium Lauryl Sulfate, Tetrasodium Pyrophosphate, Sodium Saccharin, Disodium Pyrophosphate, 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 - 59 g Tube Label

    Colgate®
    Anticavity Fluoride Toothpaste

    OPTIC
    WHITE®

    PRO SERIES

    REMOVES
    15 YEARS
    OF STAINS*

    5%
    HYDROGEN
    PEROXIDE

    ENAMEL STRENGTH

    NET WT 2.1 OZ (59 g)

    PRINCIPAL DISPLAY PANEL - 59 g Tube Label
  • INGREDIENTS AND APPEARANCE
    COLGATE OPTIC WHITE PROSERIES ENAMEL STRENGHT 
    sodium monofluorophosphate paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35000-748
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.5 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    POLOXAMER 105 (UNII: XPP85ZHV76) 446 mg  in 1 g
    CROSPOVIDONE (UNII: 2S7830E561)  
    CALCIUM PYROPHOSPHATE (UNII: X69NU20D19)  
    PEG/PPG-116/66 COPOLYMER (UNII: JP0CK963E0)  
    HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM ACID PYROPHOSPHATE (UNII: H5WVD9LZUD)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:35000-748-301 in 1 CARTON11/25/2021
    185 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:35000-748-211 in 1 CARTON11/25/2021
    259 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35511/23/2021
    Labeler - Colgate-Palmolive Company (001344381)
    Establishment
    NameAddressID/FEIBusiness Operations
    Mission Hills, S.A. de C.V.812312122ANALYSIS(35000-748) , MANUFACTURE(35000-748) , PACK(35000-748) , LABEL(35000-748)
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