Label: COLGATE MAXFRESH CHARCOAL- sodium fluoride gel, dentifrice

  • NDC Code(s): 35000-990-34, 35000-990-58, 35000-990-60, 35000-990-95, view more
    35000-990-99
  • Packager: Colgate-Palmolive Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 5, 2024

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

    Sorbitol, Water, Hydrated Silica, PEG-12, Flavor, Sodium Lauryl Sulfate, Cellulose Gum, Sodium Saccharin, Tetrasodium Pyrophosphate, Cocamidopropyl Betaine, Hydroxypropyl Methylcellulose, Blue 1, Charcoal Powder, Red 40, Titanium Dioxide, Yellow 5.

  • Questions?

    1-800-468-6502

  • SPL UNCLASSIFIED SECTION

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

  • PRINCIPAL DISPLAY PANEL - Two 170 g Tube Carton

    Colgate®
    Anticavity Fluoride Toothpaste

    Recyclable
    Tube

    CHARCOAL MINT

    2
    VALUE
    PACK

    10X
    LONGER
    LASTING
    COOL†

    MaxFresh®
    WITH WHITENING
    + CHARCOAL

    CHARCOAL MINT

    TWO 6.0 OZ (170 g) TUBES • TOTAL NET WT 12 OZ (340 g)

    PRINCIPAL DISPLAY PANEL - Two 170 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    COLGATE MAXFRESH CHARCOAL 
    sodium fluoride gel, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35000-990
    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
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    ACTIVATED CHARCOAL (UNII: 2P3VWU3H10)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:35000-990-991 in 1 CARTON10/01/2020
    153.8 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:35000-990-581 in 1 CARTON10/01/2020
    270.8 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:35000-990-601 in 1 CARTON10/24/2020
    3170 g in 1 TUBE; Type 0: Not a Combination Product
    4NDC:35000-990-342 in 1 CARTON11/16/2020
    4170 g in 1 TUBE; Type 0: Not a Combination Product
    5NDC:35000-990-951 in 1 CARTON01/29/2021
    5178 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH DRUGM02110/01/2020
    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!