Ben E. Keith FIHS
Drug Facts
Approved
Approval ID
4ca21370-1ecf-42c6-9c32-79cf994c336b
Product Type
HUMAN OTC DRUG LABEL
Effective Date
Mar 3, 2025
Manufacturers
FDA
Ben E. Keith Foods
DUNS: 007929748
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Benzalkonium Chloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50980-207
Application Number505G(a)(3)
Product Classification
M
Marketing Category
C200263
G
Generic Name
Benzalkonium Chloride
Product Specifications
Route of AdministrationTOPICAL
Effective DateMarch 3, 2025
FDA Product Classification
INGREDIENTS (9)
BENZALKONIUM CHLORIDEActive
Quantity: 1.3 mg in 1 mL
Code: F5UM2KM3W7
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
EDETATE SODIUMInactive
Code: MP1J8420LU
Classification: IACT
COCAMIDOPROPYL BETAINEInactive
Code: 5OCF3O11KX
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
PEG-7 GLYCERYL COCOATEInactive
Code: VNX7251543
Classification: IACT
PHENOXYETHANOLInactive
Code: HIE492ZZ3T
Classification: IACT
ALOE VERA LEAFInactive
Code: ZY81Z83H0X
Classification: IACT
.ALPHA.-TOCOPHEROL ACETATE, DL-Inactive
Code: WR1WPI7EW8
Classification: IACT