Label: ANTIBACTERIAL BAR BLUE CROSS- chloroxylenol soap

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 January 27, 2017

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  • ACTIVE INGREDIENT

    Chloroxylenol (PCMX) 0.30% .............. Antibacterial

  • PURPOSE

    for washing to decrease bacteria on the skin

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

  • INDICATIONS & USAGE

    ​Stop use and ask a doctor if ​- irritation and redness develop

  • WARNINGS

    For external use only

    ​When using this product ​- avoid contact with eyes. In case of eye contact, flush with plenty of water. 

  • DOSAGE & ADMINISTRATION

    • wet bar with water
    • later vigorously and wash skin
    • rinse and dry thoroughly
  • INACTIVE INGREDIENT

    Soap (sodium cocoate, sodium palm kernelate sodium palmate, sodium tallowate), water, talc, coconut acid, palm acid, tallow acid, palm kernel acid, PEG-6 methyl ether, fragrance, glycerin, sorbitol, sodium chloride, pentasodium, pentetate, tetrasodium etidronate, yellow 5, yellow 8, red 4 

  • PRINCIPAL DISPLAY PANEL

    SILK

    Antibacterial Bar Soap

    3.5 oz.

    Soap Bag

  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL BAR  BLUE CROSS
    chloroxylenol soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:22431-701
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL.3 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM COCOATE (UNII: R1TQH25F4I)  
    SODIUM PALM KERNELATE (UNII: 6H91L1NXTW)  
    SODIUM PALMATE (UNII: S0A6004K3Z)  
    SODIUM TALLOWATE, BEEF (UNII: 07RIK6QMEW)  
    WATER (UNII: 059QF0KO0R)  
    TALC (UNII: 7SEV7J4R1U)  
    COCONUT ACID (UNII: 40U37V505D)  
    PALM ACID (UNII: B6G0Y5Z616)  
    TALLOW ACID, BEEF (UNII: 5U9XZ261ER)  
    PALM KERNEL ACID (UNII: 79P21R4317)  
    PEG-6 METHYL ETHER (UNII: WXH089JZ5E)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SORBITOL (UNII: 506T60A25R)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    PENTASODIUM PENTETATE (UNII: 961TOZ5L7T)  
    ETIDRONATE TETRASODIUM (UNII: CZZ9T1T1X4)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FLUORESCEIN SODIUM (UNII: 93X55PE38X)  
    FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:22431-701-01100 g in 1 BAG; Type 0: Not a Combination Product12/06/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A12/06/2016
    Labeler - Blue Cross Laboratories, Inc (008298879)
    Registrant - Blue Cross Laboratories, Inc (008298879)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hefei Yatai Daily Chemical Products Co., Ltd.654641724manufacture(22431-701)
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