Label: ANTIBACTERIAL- chloroxylenol liquid

  • NDC Code(s): 58575-514-01, 58575-514-02
  • 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 3, 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 out of children's reach

    • 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.

  • Pro-Source individual label

    Pro-source individual label

    PRO-SOURCE                                                                                                     PACKAGED FOR USE IN A

    DISTRIBUTORS                                                                                                  WALL MOUNT

    Your Professional Source for Janitorial Supplies                                  DISPENSER

    Anti-Bacterial Hand Soap

    High Foaming

    Antiseptic Hand and Body Wash

    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.

    5063-PS                                Rev. 1.1                                PDI-3605

    Sold By: Pro-Source Distributors, Inc.

    2613 – 11th Street, Rockford, IL 61109                      Net Contents:

    815-229-9555 • WWW.PDI1SUPPLY.COM             1000ml 33.8 OZ

    Pro-Source individual label

  • Pro-Source case label

    PRO-SOURCE

    DISTRIBUTORS

    Your Professional Source for Janitorial Supplies 

    High Foaming

    Antiseptic Hand and Body Wash

    Sold By: Pro-Source Distributors, Inc.

    2613 – 11th Street, Rockford, IL 61109     

    815-229-9555

    WWW.PDI1SUPPLY.COM

    Net Contents:

    6/1000 mL BAGS

    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.

    5063-PS-CS         Rev. 1.1                                PDI-3605

    Pro-Source case label

  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL 
    chloroxylenol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58575-514
    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:58575-514-011000 mL in 1 BAG; Type 0: Not a Combination Product01/01/2018
    2NDC:58575-514-026000 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(58575-514)