Label: COLGATE OPTIC WHITE CHARCOAL- sodium fluoride paste, dentifrice

  • NDC Code(s): 35000-988-71, 35000-988-78
  • 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 December 9, 2019

If you are a consumer or patient please visit this version.

View All Sections
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Sodium Fluoride
    0.24% (0.15% 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

    Water, Hydrated Silica, Sorbitol, Glycerin, PEG-12, Pentasodium Triphosphate, Tetrapotassium Pyrophosphate, Sodium Lauryl Sulfate, Flavor, Cellulose Gum, Cocamidopropyl Betaine, Sodium Saccharin, Xanthan Gum, Charcoal Powder, Sodium Hydroxide, Blue 1, Red 40, Titanium Dioxide.

  • Questions?

    1-800-468-6502

  • SPL UNCLASSIFIED SECTION

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

  • PRINCIPAL DISPLAY PANEL - 119 g Tube Carton

    NEW

    Colgate®
    Anticavity Fluoride Toothpaste

    OPTIC
    WHITE®
    WITH CHARCOAL

    REMOVES 6X MORE SURFACE STAINS*
    WITH MICRO-POLISHING ACTION

    COOL MINT PASTE
    ENAMEL SAFE
    NET WT 4.2 OZ (119 g)

    PRINCIPAL DISPLAY PANEL - 119 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    COLGATE OPTIC WHITE CHARCOAL 
    sodium fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35000-988
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.1 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R) 191.18 mg  in 1 g
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    SORBITOL (UNII: 506T60A25R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)  
    SODIUM TRIPOLYPHOSPHATE ANHYDROUS (UNII: 9SW4PFD2FZ)  
    POTASSIUM PYROPHOSPHATE (UNII: B9W4019H5G)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    ACTIVATED CHARCOAL (UNII: 2P3VWU3H10)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorGRAY, WHITEScore    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:35000-988-711 in 1 CARTON05/05/2020
    1119 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:35000-988-781 in 1 CARTON02/21/2022
    270.8 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35505/05/2020
    Labeler - Colgate-Palmolive Company (001344381)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!