Label: CLOROX ANTIMICROBIAL- 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 25, 2016

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  • Active Ingredient

    Chloroxylenol 0.5% w/w

  • Purpose

    Antimicrobial

  • INDICATIONS & USAGE

    Uses

    • For handwashing to decrease bacteria on the skin
    • Ideal for repeated washing
  • WARNINGS

    Warnings

    For external use only

  • WHEN USING

    When using this product

    • do not use in or near eyes
    • discontinue use if irritation and redness develop, or if condition persists for more than 72 hours
  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN. In case of accidental ingestion, seek medical attention or contact a poison control center immediately.

  • DOSAGE & ADMINISTRATION

    Directions

    • Wet hands
    • Apply product
    • Wash hands thoroughly
    • Rinse vigorously
  • OTHER SAFETY INFORMATION

    Other Information

    Store at room temperature

  • INACTIVE INGREDIENT

    Inactive IngredientsCocoamidopropyl Betaine, DMDM Hydantoin, Ethylene Glycol Monostearate, FD&C Blue #1, Fragrance, Methylchloroisothiazolinone, Methylisothiazolinone, Methylparaben, PEG-120 Methyl Glucose Dioleate, Propylparaben, Sodium Chloride, Sodium Laureth Sulfate, Water.

  • Questions or Comments?

    QUESTIONS OR COMMENTS?

    Call 1-800-638-2625 or visit www.hlk.cc

  • PRINCIPAL DISPLAY PANEL

    Clorox Antimicrobial Hand Soap

    18 oz (532 mL)

    Clx Antimicrobial Hand Soap

  • INGREDIENTS AND APPEARANCE
    CLOROX ANTIMICROBIAL 
    chloroxylenol soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:26509-0011
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    GLYCOL STEARATE (UNII: 0324G66D0E)  
    SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    WATER (UNII: 059QF0KO0R)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:26509-0011-5532 mL in 1 BOTTLE; Type 0: Not a Combination Product01/25/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A01/25/2016
    Labeler - The Clorox Company (009138033)
    Registrant - Carroll Company (007372329)
    Establishment
    NameAddressID/FEIBusiness Operations
    Carroll Co.007372329manufacture(26509-0011)
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