NDC 76016-544

Pure Kleen

Chloroxylenol

Pure Kleen is a Topical Soap in the Human Otc Drug category. It is labeled and distributed by Arrow-magnolia International, Inc,. The primary component is Chloroxylenol.

Product ID76016-544_f6d5caf2-a745-4ac2-9c6b-6185578e7ee7
NDC76016-544
Product TypeHuman Otc Drug
Proprietary NamePure Kleen
Generic NameChloroxylenol
Dosage FormSoap
Route of AdministrationTOPICAL
Marketing Start Date2011-01-01
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart333E
Labeler NameArrow-Magnolia International, Inc,
Substance NameCHLOROXYLENOL
Active Ingredient Strength3 mg/mL
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 76016-544-15

946 mL in 1 BOTTLE, PLASTIC (76016-544-15)
Marketing Start Date2015-04-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 76016-544-27 [76016054427]

Pure Kleen SOAP
Marketing CategoryOTC monograph not final
Application Numberpart333E
Product TypeHUMAN OTC DRUG
Marketing Start Date2015-04-15
Inactivation Date2020-01-31

NDC 76016-544-20 [76016054420]

Pure Kleen SOAP
Marketing CategoryOTC monograph not final
Application Numberpart333E
Product TypeHUMAN OTC DRUG
Marketing Start Date2015-04-15
Inactivation Date2020-01-31

NDC 76016-544-11 [76016054411]

Pure Kleen SOAP
Marketing CategoryOTC monograph not final
Application Numberpart333E
Product TypeHUMAN OTC DRUG
Marketing Start Date2015-04-15
Inactivation Date2020-01-31

NDC 76016-544-09 [76016054409]

Pure Kleen SOAP
Marketing CategoryOTC monograph not final
Application Numberpart333E
Product TypeHUMAN OTC DRUG
Marketing Start Date2015-04-15
Inactivation Date2020-01-31

NDC 76016-544-55 [76016054455]

Pure Kleen SOAP
Marketing CategoryOTC monograph not final
Application Numberpart333E
Product TypeHUMAN OTC DRUG
Marketing Start Date2015-10-12
Inactivation Date2020-01-31

NDC 76016-544-10 [76016054410]

Pure Kleen SOAP
Marketing CategoryOTC monograph not final
Application Numberpart333E
Product TypeHUMAN OTC DRUG
Marketing Start Date2015-04-15
Inactivation Date2020-01-31

NDC 76016-544-35 [76016054435]

Pure Kleen SOAP
Marketing CategoryOTC monograph not final
Application Numberpart333E
Product TypeHUMAN OTC DRUG
Marketing Start Date2015-04-15
Inactivation Date2020-01-31

NDC 76016-544-07 [76016054407]

Pure Kleen SOAP
Marketing CategoryOTC monograph not final
Application Numberpart333E
Product TypeHUMAN OTC DRUG
Marketing Start Date2015-04-15
Inactivation Date2020-01-31

NDC 76016-544-18 [76016054418]

Pure Kleen SOAP
Marketing CategoryOTC monograph not final
Application Numberpart333E
Product TypeHUMAN OTC DRUG
Marketing Start Date2015-04-15
Inactivation Date2020-01-31

NDC 76016-544-12 [76016054412]

Pure Kleen SOAP
Marketing CategoryOTC monograph not final
Application Numberpart333E
Product TypeHUMAN OTC DRUG
Marketing Start Date2015-04-15
Inactivation Date2020-01-31

NDC 76016-544-17 [76016054417]

Pure Kleen SOAP
Marketing CategoryOTC monograph not final
Application Numberpart333E
Product TypeHUMAN OTC DRUG
Marketing Start Date2015-04-15
Inactivation Date2020-01-31

NDC 76016-544-06 [76016054406]

Pure Kleen SOAP
Marketing CategoryOTC monograph not final
Application Numberpart333E
Product TypeHUMAN OTC DRUG
Marketing Start Date2015-04-15
Inactivation Date2020-01-31

NDC 76016-544-01 [76016054401]

Pure Kleen SOAP
Marketing CategoryOTC monograph not final
Application Numberpart333E
Product TypeHUMAN OTC DRUG
Marketing Start Date2015-04-15
Inactivation Date2020-01-31

NDC 76016-544-03 [76016054403]

Pure Kleen SOAP
Marketing CategoryOTC monograph not final
Application Numberpart333E
Product TypeHUMAN OTC DRUG
Marketing Start Date2015-04-15
Inactivation Date2020-01-31

NDC 76016-544-05 [76016054405]

Pure Kleen SOAP
Marketing CategoryOTC monograph not final
Application Numberpart333E
Product TypeHUMAN OTC DRUG
Marketing Start Date2015-04-15
Inactivation Date2020-01-31

NDC 76016-544-16 [76016054416]

Pure Kleen SOAP
Marketing CategoryOTC monograph not final
Application Numberpart333E
Product TypeHUMAN OTC DRUG
Marketing Start Date2015-04-15
Inactivation Date2020-01-31

NDC 76016-544-15 [76016054415]

Pure Kleen SOAP
Marketing CategoryOTC monograph not final
Application Numberpart333E
Product TypeHUMAN OTC DRUG
Marketing Start Date2015-04-15
Inactivation Date2020-01-31

NDC 76016-544-19 [76016054419]

Pure Kleen SOAP
Marketing CategoryOTC monograph not final
Application Numberpart333E
Product TypeHUMAN OTC DRUG
Marketing Start Date2015-04-15
Inactivation Date2020-01-31

NDC 76016-544-24 [76016054424]

Pure Kleen SOAP
Marketing CategoryOTC monograph not final
Application Numberpart333E
Product TypeHUMAN OTC DRUG
Marketing Start Date2015-04-15
Inactivation Date2020-01-31

NDC 76016-544-08 [76016054408]

Pure Kleen SOAP
Marketing CategoryOTC monograph not final
Application Numberpart333E
Product TypeHUMAN OTC DRUG
Marketing Start Date2015-04-15
Inactivation Date2020-01-31

NDC 76016-544-13 [76016054413]

Pure Kleen SOAP
Marketing CategoryOTC monograph not final
Application Numberpart333E
Product TypeHUMAN OTC DRUG
Marketing Start Date2015-04-15
Inactivation Date2020-01-31

NDC 76016-544-28 [76016054428]

Pure Kleen SOAP
Marketing CategoryOTC monograph not final
Application Numberpart333E
Product TypeHUMAN OTC DRUG
Marketing Start Date2015-04-15
Inactivation Date2020-01-31

NDC 76016-544-14 [76016054414]

Pure Kleen SOAP
Marketing CategoryOTC monograph not final
Application Numberpart333E
Product TypeHUMAN OTC DRUG
Marketing Start Date2015-04-15
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
CHLOROXYLENOL3 mg/mL

OpenFDA Data

SPL SET ID:9421a965-63e9-4503-9e46-f53ff15cafe1
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 413261

    • NDC Crossover Matching brand name "Pure Kleen" or generic name "Chloroxylenol"

    NDCBrand NameGeneric Name
    76016-544Pure KleenPure Kleen
    75455-001Pure KleenPure Kleen
    75455-002Pure KleenPure Kleen
    11084-800Acute-KareCHLOROXYLENOL
    0404-4441Antibacterialchloroxylenol
    11344-713antibacterialchloroxylenol
    0404-4438Antibacterial Handchloroxylenol
    0404-5987Antimicrobial Hand WashChloroxylenol
    0404-5990Antimicrobial Hand WashChloroxylenol
    16496-544Antiseptic HandCHLOROXYLENOL
    17271-116BD E-Z SCRUBchloroxylenol
    11344-710chloroxylenolchloroxylenol
    11084-232Clean Choice AntibacterialChloroxylenol
    11429-1007Derma 1 Healthcare Hand WashCHLOROXYLENOL
    10802-8081Derma CIDOL 2000Chloroxylenol
    11429-1005FoamFresh Antibacterial Hand WashCHLOROXYLENOL
    11429-1010FoamFresh Dye Free Antibacterial Hand WashCHLOROXYLENOL
    11429-1011FoamFresh E-2 Sanitizer Cleanser with PCMXChloroxylenol
    11429-1008FoamFresh Healthcare Hand WashCHLOROXYLENOL
    11084-036Kindest Kare HandCHLOROXYLENOL
    11429-1006Lemon Drop Gentle AntisepticCHLOROXYLENOL
    10685-978NAMICO ANTISEPTIC HAND CLEANER 557CHLOROXYLENOL
    10685-511PC511 ANTIMICROBIALCHLOROXYLENOL
    10685-529PC529 ULTREXCHLOROXYLENOL
    10685-537PC537 E-2 BRUTECHLOROXYLENOL
    10685-557PC557 PALPONCHLOROXYLENOL
    11429-1009Pink AntibacterialCHLOROXYLENOL
    11084-131PureBac Foam WashChloroxylenol
    11084-003Refresh ClearBac FmChloroxylenol
    11084-160Refresh PureBac FoamChloroxylenol
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.