Label: COLGATE GREAT REGULAR FLAVOR- sodium monofluorophosphate paste, dentifrice

  • NDC Code(s): 35000-913-01, 35000-913-04, 35000-913-20, 35000-913-33, view more
    35000-913-46, 35000-913-48, 35000-913-58, 35000-913-60, 35000-913-64, 35000-913-69, 35000-913-79, 35000-913-82, 35000-913-92, 35000-913-93
  • 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 3, 2019

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Sodium monofluorophosphate 0.76% (0.15% w/v fluoride ion)

  • Purpose

    Anticavity

  • Use

    helps protect against cavities

  • Warnings

    Keep out of the 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

    dicalcium phosphate dihydrate, water, glycerin, sodium lauryl sulfate, cellulose gum, flavor, tetrasodium pyrophosphate, sodium saccharin

  • Questions or comments?

    Call toll-free 1-800-468-6502

  • SPL UNCLASSIFIED SECTION

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

  • PRINCIPAL DISPLAY PANEL - 113 g Tube Carton

    Colgate®
    Anticavity
    Fluoride Toothpaste

    ADA
    Accepted
    American
    Dental
    Association ®

    NET WT 4.0 OZ (113 g)

    Cavity
    Protection

    Strengthens Teeth
    with Active Fluoride

    Great Regular Flavor

    PRINCIPAL DISPLAY PANEL - 113 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    COLGATE GREAT REGULAR FLAVOR  
    sodium monofluorophosphate paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35000-913
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.0 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM LAURYL SULFATE (UNII: 368GB5141J) 49.14 mg  in 1 g
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:35000-913-2024 g in 1 TUBE; Type 0: Not a Combination Product11/05/2005
    2NDC:35000-913-331 in 1 CARTON11/05/2005
    236.8 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:35000-913-691 in 1 CARTON11/05/2005
    3113 g in 1 TUBE; Type 0: Not a Combination Product
    4NDC:35000-913-461 in 1 CARTON11/05/2005
    4130 g in 1 TUBE; Type 0: Not a Combination Product
    5NDC:35000-913-60170 g in 1 TUBE; Type 0: Not a Combination Product11/05/2005
    6NDC:35000-913-641 in 1 CARTON11/05/2005
    6181 g in 1 TUBE; Type 0: Not a Combination Product
    7NDC:35000-913-821 in 1 CARTON11/05/2005
    7232 g in 1 TUBE; Type 0: Not a Combination Product
    8NDC:35000-913-044.25 g in 1 POUCH; Type 0: Not a Combination Product11/05/2005
    9NDC:35000-913-791 in 1 CARTON11/05/2005
    979 g in 1 TUBE; Type 0: Not a Combination Product
    10NDC:35000-913-9399 g in 1 TUBE; Type 0: Not a Combination Product11/05/2005
    11NDC:35000-913-481 in 1 CARTON11/05/2005
    11226 g in 1 TUBE; Type 0: Not a Combination Product
    12NDC:35000-913-011 in 1 CARTON11/05/2005
    1228 g in 1 TUBE; Type 0: Not a Combination Product
    13NDC:35000-913-581 in 1 CARTON11/05/2005
    1370 g in 1 TUBE; Type 0: Not a Combination Product
    14NDC:35000-913-921 in 1 CARTON11/05/2005
    14141 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35511/05/2005
    Labeler - Colgate-Palmolive Company (001344381)
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