Label: COLGATE BAKING SODA AND PEROXIDE WHITENING OXYGEN BUBBLES FROSTY MINT- sodium monofluorophosphate paste, dentifrice

  • NDC Code(s): 65954-768-60, 65954-768-64, 65954-768-69, 65954-768-82
  • Packager: Mission Hills S.A de C.V
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated April 29, 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, FD&C blue no. 1, D&C yellow no. 10

  • Questions?

    1-800-468-6502

  • SPL UNCLASSIFIED SECTION

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

  • PRINCIPAL DISPLAY PANEL - 232 g Tube Label

    Colgate®
    Fluoride Toothpaste

    NET WT 8.2 OZ (232 g)

    Baking Soda
    & Peroxide
    Whitening

    Cleans Deep and
    Whitens Teeth

    Frosty Mint®Stripe Gel

    PRINCIPAL DISPLAY PANEL - 232 g Tube Label
  • INGREDIENTS AND APPEARANCE
    COLGATE  BAKING SODA AND PEROXIDE WHITENING OXYGEN BUBBLES FROSTY MINT
    sodium monofluorophosphate paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65954-768
    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)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorGREEN, WHITEScore    
    ShapeSize
    FlavorSPEARMINT, PEPPERMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65954-768-691 in 1 CARTON08/20/2011
    1113 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:65954-768-641 in 1 CARTON08/20/201112/31/2017
    2181 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:65954-768-821 in 1 CARTON08/20/201112/31/2017
    3232 g in 1 TUBE; Type 0: Not a Combination Product
    4NDC:65954-768-601 in 1 CARTON08/20/2011
    4170 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(65954-768) , MANUFACTURE(65954-768) , PACK(65954-768) , LABEL(65954-768)
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