MedPath

AFCO 5511 Sanifect E3

66949-140 / 0900 AFCO Sanifect E3

Approved
Approval ID

34795eba-9ec4-6401-e063-6394a90af428

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 5, 2025

Manufacturers
FDA

Zep Inc.

DUNS: 030471374

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Ethanol

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code66949-140
Application Number505G(a)(3)
Product Classification
M
Marketing Category
C200263
G
Generic Name
Ethanol
Product Specifications
Route of AdministrationTOPICAL
Effective DateMay 5, 2025
FDA Product Classification

INGREDIENTS (3)

WATERInactive
Code: 059QF0KO0R
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
ALCOHOLActive
Quantity: 70 mL in 100 mL
Code: 3K9958V90M
Classification: ACTIB

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.

AFCO 5511 Sanifect E3 - FDA Drug Approval Details