Label: MICRO-ASEPTIC- chloroxylenol liquid

  • NDC Code(s): 81591-001-01, 81591-001-02, 81591-001-03
  • Packager: ASEPTIC CONTROL PRODUCTS, INC.
  • 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 February 26, 2021

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  • Active Ingredient

    PCMX (para-chloro-meta-xylenol) 0.6%

  • Purpose

    Antimicrobial

  • Use

    for hand-washing to decrease bacteria on the skin

  • Warnings

    For external use only

    When using this product

    • do not get into eyes
    • of contact occurs, rinse eyes thoroughly with water

    Stop use and ask a doctor if

    • irritation and redness develop

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control center right away

  • Directions

    • ready to use
    • do not dilute
    • wet hands and forearms
    • apply 5 milliters (teaspoonful) or palmful to hands and forearms
    • scrub thoroughly for 1 minute and rinse
  • Inactive Ingredients

    Water, Sodium Lauryl Sulfate, Sodium Laureth Sulfate, Cocamidopropylbetaine, Propylene Glycol, Tetrasodium EDTA, Isopropanol, Lauramine oxide, Boric Acid, PEG-75 Lanolin, DMDM Hydantoin, Fragrance, Aloe Vera, FD&C Blue #1, FD&C Yellow #5

  • PRINCIPAL DISPLAY PANEL

    Micro-

    Aseptic

    Antimicrobial

    Skin Cleanser

    NDC # 81591-001-02

    Manufactured for

    ASEPTIC CONTROL PRODUCTS, INC

    1225 Carnegie Street, Unit 104

    Rolling Meadows, IL 60008

    Made in the U.S.A.

    Item #: 1955-16OZ

    473 ml (16 FL. OZ.)

    container label

  • INGREDIENTS AND APPEARANCE
    MICRO-ASEPTIC 
    chloroxylenol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81591-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL0.6 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    PEG-75 LANOLIN (UNII: 09179OX7TB)  
    LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    BORIC ACID (UNII: R57ZHV85D4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81591-001-01118 mL in 1 BOTTLE; Type 0: Not a Combination Product02/26/2021
    2NDC:81591-001-02473 mL in 1 BOTTLE; Type 0: Not a Combination Product02/26/2021
    3NDC:81591-001-033785 mL in 1 BOTTLE; Type 0: Not a Combination Product02/26/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A02/26/2021
    Labeler - ASEPTIC CONTROL PRODUCTS, INC. (161977020)
    Establishment
    NameAddressID/FEIBusiness Operations
    Enzyme Solutions, Inc.004994559manufacture(81591-001)
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