NDC 50302-540

Hand Antibacterial

Chloroxylenol

Hand Antibacterial is a Topical Soap in the Human Otc Drug category. It is labeled and distributed by Panrosa Enterprises, Inc.. The primary component is Chloroxylenol.

Product ID50302-540_6d97b3ee-6470-9b7e-e053-2991aa0aa1b3
NDC50302-540
Product TypeHuman Otc Drug
Proprietary NameHand Antibacterial
Generic NameChloroxylenol
Dosage FormSoap
Route of AdministrationTOPICAL
Marketing Start Date2016-05-20
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart333E
Labeler NamePANROSA ENTERPRISES, INC.
Substance NameCHLOROXYLENOL
Active Ingredient Strength3 mg/mL
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 50302-540-00

500 mL in 1 BOTTLE (50302-540-00)
Marketing Start Date2016-05-20
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50302-540-00 [50302054000]

Hand Antibacterial SOAP
Marketing CategoryOTC monograph not final
Application Numberpart333E
Product TypeHUMAN OTC DRUG
Marketing Start Date2016-05-20
Inactivation Date2020-01-31

NDC 50302-540-01 [50302054001]

Hand Antibacterial SOAP
Marketing CategoryOTC monograph not final
Application Numberpart333E
Product TypeHUMAN OTC DRUG
Marketing Start Date2016-05-20
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
CHLOROXYLENOL2.5 mg/mL

OpenFDA Data

SPL SET ID:b7f953ce-1261-4534-9fe6-76dd56dd4180
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1435989
  • UPC Code
  • 0651669000391
  • NDC Crossover Matching brand name "Hand Antibacterial" or generic name "Chloroxylenol"

    NDCBrand NameGeneric Name
    50302-540Hand AntibacterialHand Antibacterial
    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

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