MedPath

Isopropyl Alcohol

Drug Facts

Approved
Approval ID

25601132-3eff-4361-b0a9-ea6493a2091d

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Apr 9, 2025

Manufacturers
FDA

TOP CARE (Topco Associates LLC)

DUNS: 006935977

Products 1

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

Isopropyl Alcohol

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code36800-276
Application NumberM003
Product Classification
M
Marketing Category
C200263
G
Generic Name
Isopropyl Alcohol
Product Specifications
Route of AdministrationTOPICAL
Effective DateApril 9, 2025
FDA Product Classification

INGREDIENTS (5)

FD&C YELLOW NO. 5Inactive
Code: I753WB2F1M
Classification: IACT
METHYL SALICYLATEInactive
Code: LAV5U5022Y
Classification: IACT
ISOPROPYL ALCOHOLActive
Quantity: 70 mL in 100 mL
Code: ND2M416302
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
FD&C GREEN NO. 3Inactive
Code: 3P3ONR6O1S
Classification: IACT

MedPath

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

© 2025 MedPath, Inc. All rights reserved.

Isopropyl Alcohol - FDA Drug Approval Details