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

  • NDC Code(s): 35000-913-01, 35000-913-04, 35000-913-20, 35000-913-30, view more
    35000-913-33, 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

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 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 (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
    15NDC:35000-913-303 in 1 CARTON11/05/2005
    15170 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH DRUGM02111/05/2005
    Labeler - Colgate-Palmolive Company (001344381)
    Registrant - Colgate-Palmolive Company (001344381)
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