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

  • NDC Code(s): 35000-959-46, 35000-959-48, 35000-959-58, 35000-959-60, view more
    35000-959-64, 35000-959-69, 35000-959-75, 35000-959-82, 35000-959-92
  • 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 13, 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:35000-959
    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 FORM (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:35000-959-461 in 1 CARTON08/20/2011
    1130 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:35000-959-641 in 1 CARTON08/20/2011
    2181 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:35000-959-821 in 1 CARTON08/20/2011
    3232 g in 1 TUBE; Type 0: Not a Combination Product
    4NDC:35000-959-691 in 1 CARTON08/20/2011
    4113 g in 1 TUBE; Type 0: Not a Combination Product
    5NDC:35000-959-751 in 1 CARTON08/20/2011
    579 g in 1 TUBE; Type 0: Not a Combination Product
    6NDC:35000-959-601 in 1 CARTON08/20/2011
    6170 g in 1 TUBE; Type 0: Not a Combination Product
    7NDC:35000-959-481 in 1 CARTON08/20/2011
    7226 g in 1 TUBE; Type 0: Not a Combination Product
    8NDC:35000-959-581 in 1 CARTON08/20/2011
    870 g in 1 TUBE; Type 0: Not a Combination Product
    9NDC:35000-959-921 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 FINALpart35508/20/2011
    Labeler - Colgate-Palmolive Company (001344381)
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