Label: TRICLOSAN FREE ANTIBACTERIAL 7.5 OZ ORIGINAL ANTIBACTERIAL- chloroxylenol liquid

  • NDC Code(s): 58503-101-01
  • Packager: China Ningbo Shangge Cosmetic Technology Corp.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated September 18, 2019

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  • PURPOSE

    Purpose

    Antibacterial

  • ACTIVE INGREDIENT

    Active Ingredient

    Chloroexylenol, 0.3%

  • INDICATIONS & USAGE

    USAGE

    For hand washing to decrease bacteria on the skin

  • DOSAGE & ADMINISTRATION

    Directions

    Pump into hands

    Lather vigorously for at least 15 seconds

    Rinse and dry thoroughly

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

    If swallowed get medical help or contact a poison control center right away.

  • WARNINGS

    Warnings


    For external use only

    When using this product avoid contact with eyes; in case of eye contact, flush with water

    Stop use and ask a doctor if irritation and redness develops

  • INACTIVE INGREDIENT

    WATER, SODIUM LAURETH SULFATE, COCAMIDE MEA, SODIUM C14-16 OLEFIN SULFONATE, SODIUM CHLORIDE, PEG-150 DISTEARATE, FRAGRANCE, CITRIC ACID, GLYCERIN, PEG-40 HYDROGENATED CASTOR OIL, DISODIUM EDTA, TOCOPHERYL ACETATE, METHYLCHLOROTHIAZOLINONE, METHYLISOTHIAZOLINONE, FD&C YELLOW NO.5, D&C RED NO. 33

  • PRINCIPAL DISPLAY PANEL

    image

  • INGREDIENTS AND APPEARANCE
    TRICLOSAN FREE ANTIBACTERIAL 7.5 OZ ORIGINAL  ANTIBACTERIAL
    chloroxylenol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58503-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL0.3 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    DISODIUM EDTA-COPPER (UNII: 6V475AX06U)  
    COCO MONOETHANOLAMIDE (UNII: C80684146D)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58503-101-01221 mL in 1 BOTTLE; Type 0: Not a Combination Product06/06/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other06/06/2017
    Labeler - China Ningbo Shangge Cosmetic Technology Corp. (529287434)
    Establishment
    NameAddressID/FEIBusiness Operations
    China Ningbo Shangge Cosmetic Technology Corp.529287434manufacture(58503-101)
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