NDC 58575-401

Bortek E-2 Foaming Hand Wash

Benkalkonium Chloride

Bortek E-2 Foaming Hand Wash is a Topical Liquid in the Human Otc Drug category. It is labeled and distributed by Inopak, Ltd.. The primary component is Benzalkonium Chloride.

Product ID58575-401_af5b57ed-c5b1-4d1c-aca2-75c4a51354fd
NDC58575-401
Product TypeHuman Otc Drug
Proprietary NameBortek E-2 Foaming Hand Wash
Generic NameBenkalkonium Chloride
Dosage FormLiquid
Route of AdministrationTOPICAL
Marketing Start Date2018-01-01
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart333A
Labeler NameInopak, Ltd.
Substance NameBENZALKONIUM CHLORIDE
Active Ingredient Strength0 mg/mL
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 58575-401-01

1000 mL in 1 CONTAINER (58575-401-01)
Marketing Start Date2018-01-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 58575-401-02 [58575040102]

Bortek E-2 Foaming Hand Wash LIQUID
Marketing CategoryOTC monograph not final
Application Numberpart333A
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-01-01

NDC 58575-401-01 [58575040101]

Bortek E-2 Foaming Hand Wash LIQUID
Marketing CategoryOTC monograph not final
Application Numberpart333A
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-01-01

Drug Details

Active Ingredients

IngredientStrength
BENZALKONIUM CHLORIDE.13 mg/mL

OpenFDA Data

SPL SET ID:86dbf3e6-f734-4012-aa5e-b04b0c55fd31
Manufacturer
UNII

NDC Crossover Matching brand name "Bortek E-2 Foaming Hand Wash" or generic name "Benkalkonium Chloride"

NDCBrand NameGeneric Name
58575-401Bortek E-2 Foaming Hand WashBenkalkonium chloride
81731-401Bortek E-2 Foaming Hand WashBenzalkonium chloride
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