Label: TRICLOSAN FREE ANTIBACTERIAL 7.5 OZ (OCEAN) ANTIBACTERIAL- chloroxylenol liquid

  • NDC Code(s): 58503-102-01
  • Packager: China Ningbo Shangge Cosmetic Technology Corp.
  • Category: HUMAN OTC DRUG LABEL

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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; FD&C BLUE NO. 1

  • PRINCIPAL DISPLAY PANEL

    image

  • INGREDIENTS AND APPEARANCE
    TRICLOSAN FREE ANTIBACTERIAL 7.5 OZ (OCEAN)  ANTIBACTERIAL
    chloroxylenol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58503-102
    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)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58503-102-01221 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(58503-102)