MedPath

Hand Wash

Equaline 628.002/628AD-AF Antibacterial Foaming Hand Wash

Approved
Approval ID

2757aafa-9d03-4ad0-9b6b-8cb9ef3cdd90

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Apr 9, 2025

Manufacturers
FDA

United Natural Foods, Inc. dba UNFI

DUNS: 943556183

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 Code41163-628
Application Number505G(a)(3)
Product Classification
M
Marketing Category
C200263
G
Generic Name
Benzalkonium chloride
Product Specifications
Route of AdministrationTOPICAL
Effective DateApril 9, 2025
FDA Product Classification

INGREDIENTS (13)

WATERInactive
Code: 059QF0KO0R
Classification: IACT
LAURAMIDOPROPYLAMINE OXIDEInactive
Code: I6KX160QTV
Classification: IACT
LAURAMINE OXIDEInactive
Code: 4F6FC4MI8W
Classification: IACT
COCAMIDOPROPYL BETAINEInactive
Code: 5OCF3O11KX
Classification: IACT
MYRISTAMIDOPROPYLAMINE OXIDEInactive
Code: 3HSF539C9T
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
EDETATE SODIUMInactive
Code: MP1J8420LU
Classification: IACT
SULISOBENZONEInactive
Code: 1W6L629B4K
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
D&C RED NO. 33Inactive
Code: 9DBA0SBB0L
Classification: IACT
BENZALKONIUM CHLORIDEActive
Quantity: 1.3 mg in 1 mL
Code: F5UM2KM3W7
Classification: ACTIB

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