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

  • NDC Code(s): 51442-330-63
  • Packager: Colgate-Palmolive Canada
  • 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 August 12, 2009

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active ingredient

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

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  • Purpose

    Anticavity

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  • Use

    helps protect against cavities

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  • 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.

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  • Directions

    adults and children 2 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 2 to 6 years use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing)
    children under 2 years ask a dentist or physician
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  • Inactive ingredients

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

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  • Questions or comments?

    Call toll-free 1-800-468-6502

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  • SPL UNCLASSIFIED SECTION

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

    www.colgate.com

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  • PRINCIPAL DISPLAY PANEL - 85 gram Tube

    Colgate®
    Fluoride Toothpaste

    ADA
    Accepted
    American
    Dental
    Association®

    NET WT 3.0 OZ (85 g)

    Cavity
    Protection

    Strengthens Teeth
    with Active Fluoride

    Great Regular Flavor

    PRINCIPAL DISPLAY PANEL - 85 gram Tube
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  • PRINCIPAL DISPLAY PANEL - 85 gram Tube Carton

    Colgate®
    Fluoride Toothpaste

    ADA
    Accepted
    American
    Dental
    Association®

    NET WT 3.0 OZ (85 g)

    Cavity
    Protection

    Strengthens Teeth
    with Active Fluoride

    Great Regular Flavor

    PRINCIPAL DISPLAY PANEL - 85 gram Tube Carton
    Close
  • INGREDIENTS AND APPEARANCE
    COLGATE TOOTHPASTE   GREAT REGULAR FLAVOR
    sodium monofluorophosphate paste, dentifrice
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:51442-330
    Route of Administration DENTAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Sodium Monofluorophosphate (UNII: C810JCZ56Q) (fluoride ion - UNII:Q80VPU408O) Sodium Monofluorophosphate 7.6 mg  in 1 g
    Product Characteristics
    Color WHITE Score     
    Shape Size
    Flavor MINT Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:51442-330-63 1 in 1 CARTON
    1 85 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part355 06/04/2009
    Labeler - Colgate-Palmolive Canada (259157246)
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