Label: ANTIBACTERIAL- chloroxylenol liquid

  • 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 May 4, 2019

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

  • Active Ingredient

    Chloroxylenol 0.3%

  • Purpose

    Antibacterial

  • 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.
  • when using

    Do not get into eyes. 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 reach of 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.

  • Handy Klenz individual label

    Clean

    Gold Antibacterial Foaming Hand Soap

    HK

    Handy-Klenz

    Product# 72401063                                          1000ml

    Fits the CLEAN by Handy-Klenz                  MADE

    Touch Free Dispenser #72401000              IN THE USA

    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.

    Questions? Call 1-800-767-7725 or visit our website www.inopak.com

    5063FL-HK                                                                           Rev. 1.1

    Handy Klenz individual label

  • Handy Klenz case label

                                                                                                                                    5063FL-HKCS      Rev. 101

    Clean

    Gold Antibacterial

    Foaming Hand Soap

    HK

    Handy-Klenz

    6 X 1000ml

    Product# 72401063

    Fits the CLEAN by Handy-Klenz Touch Free Dispenser #72401000                                79921 91063

    Handy Klenz case label

  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL 
    chloroxylenol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58575-510
    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:58575-510-011000 mL in 1 BOTTLE, DISPENSING; 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(58575-510)