Label: CO OH SO DAZZLING SWEET MINT- sodium monofluorophosphate paste, dentifrice

  • NDC Code(s): 35000-135-69
  • Packager: Colgate-Palmolive Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 14, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Sodium Monofluorophosphate 1.14% (0.20% 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.

  • DOSAGE & ADMINISTRATION

    adults and children 6 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 6 to 12 yearsuse only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing)
    children under 6 yearsdo not use unless directed by a dentist or physician
  • Inactive ingredients

    Poloxamer 105, Calcium Pyrophosphate, Triacetin, PEG-12, PVP, PEG/PPG-116/66 Copolymer, Tetrasodium Pyrophosphate, Silica, Flavor, Betaine, Sodium Lauryl Sulfate, Sodium Saccharin, Hydrogen Peroxide, Sucralose, Carboxylesterase, Maltodextrin, BHT.

  • Questions?

    1-855-658-0289

  • SPL UNCLASSIFIED SECTION

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

  • PRINCIPAL DISPLAY PANEL - 113 g Tube Carton

    CO.
    Colgate

    Oh So
    Dazzling
    Toothpaste

    Sweet Mint

    Effortless Whitening

    Hydrogen Peroxide +
    Enzyme Technology

    Anticavity Toothpaste
    NET WT 4.0 OZ (113 g)

    PRINCIPAL DISPLAY PANEL - 113 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    CO OH SO DAZZLING SWEET MINT 
    sodium monofluorophosphate paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35000-135
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.5 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    POLOXAMER 105 (UNII: XPP85ZHV76)  
    CALCIUM PYROPHOSPHATE (UNII: X69NU20D19)  
    TRIACETIN (UNII: XHX3C3X673)  
    POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    PEG/PPG-116/66 COPOLYMER (UNII: JP0CK963E0)  
    SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    BETAINE (UNII: 3SCV180C9W)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    COCAINE ESTERASE (UNII: RP76COW7LH)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:35000-135-691 in 1 CARTON11/01/202006/30/2024
    1113 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH DRUGM02111/01/202006/30/2024
    Labeler - Colgate-Palmolive Company (001344381)
    Establishment
    NameAddressID/FEIBusiness Operations
    Colgate Palmolive Manufacturing (Poland) Sp. z o.o.524937331ANALYSIS(35000-135) , LABEL(35000-135) , MANUFACTURE(35000-135) , PACK(35000-135)
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