Label: ANTIBACTERIAL- chloroxylenol liquid

  • NDC Code(s): 58575-513-01, 58575-513-02
  • Packager: Inopak, Ltd
  • 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 2, 2020

If you are a consumer or patient please visit this version.

  • Active Ingredient

    Parachlorometaxylenol 0.3%

  • Purpose

    Antiseptic

  • Use

    • Handwash to help reduce bacteria on the skin that potentially can cause disease.
    • Recommended for repeated use.
  • Warnings

    • For external use only
    • Keep out of eyes, ears or mouth. In case of eye contact, flush eyes with water.
    • Stop use and ask a doctor if irritation or redness develop or if condition persists for more than 72 hours.
    • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
  • When using

    • Keep out of eyes, ears or mouth. In case of eye contact, flush eyes with water.
  • Stop use

    • Stop use and ask a doctor if irritation or redness develop or if condition persists for more than 72 hours.
  • Keep away from children

    • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
  • Directions

    • Wet hands with water and dispense sufficient amount of product into cupped palm of hand.
    • Wash both hands thoroughly for 15 minutes.
    • Rinse under running water and dry thoroughly.
  • Inactive ingredients

    Citric acid, Cocamide DEA, DMDM Hydantoin, Ethyl Alcohol, FD&C Red 4, Fragrance, Isopropyl Alcohol, Phenoxyethanol, Sodium Laureth Sulfate, Water.

  • Greenex individual label

    GREENEX                             5063-OS-GX        Rev 1.0

                    ANTIBACTERIAL FOAM

    HAND SOAP

                    With 0.3% PCMX

    Drug Facts

    Active Ingredient                                         Purpose

    Parachlorometaxylenol 0.3% w/w           Antiseptic

    Uses

    • Handwash to help reduce bacteria on the skin that potentially can cause disease.
    • Recommended for repeated use.

    Warnings

    • For external use only
    • Keep out of eyes, ears or mouth. In case of eye contact, flush eyes with water.
    • Stop use and ask a doctor if irritation or redness develop or if condition persists for more than 72 hours.
    • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

    Directions

    • Wet hands with water and dispense sufficient amount of product into cupped palm of hand.
    • Wash both hands thoroughly for 15 minutes.
    • Rinse under running water and dry thoroughly.

    Inactive ingredients: Citric acid, Cocamide DEA, DMDM Hydantoin, Ethyl Alcohol, FD&C Red 4, Fragrance, Isopropyl Alcohol, Phenoxyethanol, Sodium Laureth Sulfate, Water.

    GREENEX             2 Bergen Turnpike                                           MADE IN THE

                                    Ridgefield Park, NJ 07660                              USA                                       1000 ml

    Greenex Individual Label

  • Greenex Case label

                                                    5063-GX-CS

                                                    Rev 1.0

                                    GREENEX

    ANTIBACTERIAL FOAM

    HAND SOAP

    With 0.3% PCMX

    GREENEX

    GREENEX CLEAN INC.

    2 Bergen Turnpike

    Ridgefield Park, NJ 07660

    MADE IN THE

    USA                       6/1000ML Cartridges

    Greenex Case label

  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL 
    chloroxylenol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58575-513
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    COCAMIDOPROPYL DIMETHYLAMINE (UNII: L36BM7DG2T)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    ALCOHOL (UNII: 3K9958V90M)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58575-513-011000 mL in 1 CARTRIDGE; Type 0: Not a Combination Product01/01/2018
    2NDC:58575-513-026000 mL in 1 CASE; Type 0: Not a Combination Product01/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A01/01/2018
    Labeler - Inopak, Ltd (194718243)
    Establishment
    NameAddressID/FEIBusiness Operations
    Inopak, Ltd194718243manufacture(58575-513)