Label: COLGATE BAKING SODA AND PEROXIDE WHITENING BRISK MINT- sodium monofluorophosphate paste, dentifrice

  • NDC Code(s): 65954-765-46, 65954-765-48, 65954-765-58, 65954-765-60, view more
    65954-765-64, 65954-765-69, 65954-765-75, 65954-765-82, 65954-765-92
  • Packager: Mission Hills, S.A. de C.V.
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated April 3, 2019

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Sodium monofluorophosphate 0.76% (0.14% 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

    glycerin, hydrated silica, water, sodium bicarbonate, PEG-12, sodium lauryl sulfate, flavor, sodium hydroxide, cellulose gum, carrageenan, sodium saccharin, calcium peroxide, titanium dioxide

  • Questions?

    1-800-468-6502

  • SPL UNCLASSIFIED SECTION

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

  • PRINCIPAL DISPLAY PANEL - 130 g Carton

    Colgate®
    Fluoride Toothpaste

    NET WT 4.6 OZ (130 g)

    Baking Soda
    & Peroxide
    Whitening

    Cleans Deep and
    Whitens Teeth

    Brisk Mint®Paste

    PRINCIPAL DISPLAY PANEL - 130 g Cartonl
  • INGREDIENTS AND APPEARANCE
    COLGATE  BAKING SODA AND PEROXIDE WHITENING BRISK MINT
    sodium monofluorophosphate paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65954-765
    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
    GLYCERIN (UNII: PDC6A3C0OX) 491.6 mg  in 1 g
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
    CARRAGEENAN (UNII: 5C69YCD2YJ)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    CALCIUM PEROXIDE (UNII: 7FRO2ENO91)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorPEPPERMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65954-765-461 in 1 CARTON08/20/2011
    1130 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:65954-765-641 in 1 CARTON08/20/2011
    2181 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:65954-765-821 in 1 CARTON08/20/2011
    3232 g in 1 TUBE; Type 0: Not a Combination Product
    4NDC:65954-765-691 in 1 CARTON08/20/2011
    4113 g in 1 TUBE; Type 0: Not a Combination Product
    5NDC:65954-765-751 in 1 CARTON08/20/2011
    579 g in 1 TUBE; Type 0: Not a Combination Product
    6NDC:65954-765-601 in 1 CARTON08/20/2011
    6170 g in 1 TUBE; Type 0: Not a Combination Product
    7NDC:65954-765-481 in 1 CARTON08/20/2011
    7226 g in 1 TUBE; Type 0: Not a Combination Product
    8NDC:65954-765-581 in 1 CARTON08/20/2011
    870 g in 1 TUBE; Type 0: Not a Combination Product
    9NDC:65954-765-921 in 1 CARTON08/20/2011
    9141 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH DRUGM02108/20/2011
    Labeler - Mission Hills, S.A. de C.V. (812312122)
    Establishment
    NameAddressID/FEIBusiness Operations
    Mission Hills, S.A. de C.V.812312122ANALYSIS(65954-765) , MANUFACTURE(65954-765) , PACK(65954-765) , LABEL(65954-765)
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