Label: E-ZEN GARGLE- cetylpyridinium chloride liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated February 8, 2014

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  • ACTIVE INGREDIENT

    Cetylpyridinium chloride

  • INACTIVE INGREDIENT

    Xylitol, Glucosyl Stevioside, Sodium Saccharin, Disodium EDTA, Glycerin, Blue No.1, Sodium citrate, Ethanol, Methylparaben, Polyoxyethylene Hydrogenated Castor Oil, Menthol, Mentha Oil, Purified water


  • PURPOSE

    Plaque removal. Mouth cleanliness, Halitosis removal

  • KEEP OUT OF REACH OF CHILDREN

    keep out or reach of the children


  • INDICATIONS & USAGE

    -Before going to bed or after eating, wash your mouth out with 12ML of gargling liquid.-Gargle with E-zen frequently when your mouth doesn't feel fresh.

  • WARNINGS

    Never let children under the age of 6 use the product.Keep out of reach of children.Children under the age of 7 must use the product under the guidance of an adult.In case of accidental swallowing, see a doctor.

  • DOSAGE & ADMINISTRATION

    dental use only


  • PRINCIPAL DISPLAY PANEL

    package label
  • INGREDIENTS AND APPEARANCE
    E-ZEN GARGLE 
    cetylpyridinium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62040-2001
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3) CETYLPYRIDINIUM CHLORIDE0.005 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    XYLITOL (UNII: VCQ006KQ1E)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62040-2001-112 mL in 1 POUCH
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other02/08/2014
    Labeler - JN Pharm (689048618)
    Registrant - JN Pharm (689048618)
    Establishment
    NameAddressID/FEIBusiness Operations
    JN Pharm689048618manufacture(62040-2001)
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