Label: COLGATE CAVITY PROTECTION- sodium fluoride gel, dentifrice

  • NDC Code(s): 65954-559-71
  • Packager: Mission Hills S.A de C.V
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 01/13

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active ingredient

    Sodium fluoride 0.24% (0.15% w/v fluoride

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  • Purpose

    Anticavity

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  • Use

    helps protect against cavities

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  • 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.

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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

    sorbitol, water, hydrated silica, sodium lauryl sulfate, PEG-12, flavor, cellulose gum, sodium saccharin, FD&C red no. 40

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  • Questions?

    1-800-468-6502

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  • SPL UNCLASSIFIED SECTION

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

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  • PRINCIPAL DISPLAY PANEL - 119 g Tube Label

    Cavity
    Protection

    Gel

    Helps
    Strengthen
    Teeth

    Colgate®
    Fluoride Toothpaste

    ADA
    Accepted
    American
    Dental
    Association ®

    Toothpaste

    NET WT
    4.2 OZ
    (119 g)

    PRINCIPAL DISPLAY PANEL - 119 g Tube Label
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  • INGREDIENTS AND APPEARANCE
    COLGATE   CAVITY PROTECTION
    sodium fluoride gel, dentifrice
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:65954-559
    Route of Administration DENTAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION 1.1 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    SORBITOL 339.99 mg  in 1 g
    WATER  
    HYDRATED SILICA  
    SODIUM LAURYL SULFATE  
    POLYETHYLENE GLYCOL 600  
    CARBOXYMETHYLCELLULOSE SODIUM  
    SACCHARIN SODIUM  
    FD&C RED NO. 40  
    Product Characteristics
    Color RED Score     
    Shape Size
    Flavor MINT Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:65954-559-71 147 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part355 02/25/2012
    Labeler - Mission Hills S.A de C.V (812312122)
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