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
  • 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 October 29, 2020

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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 CARTON11/01/2020
    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 FINALpart35511/01/2020
    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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