Ketoconazole
Ketoconazole Shampoo
1f5cd9f4-0db4-4062-b5ec-c33611265e02
HUMAN PRESCRIPTION DRUG LABEL
Mar 28, 2022
THIRTY MADISON INC
DUNS: 080774087
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Ketoconazole
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (11)
Drug Labeling Information
HOW SUPPLIED SECTION
HOW SUPPLIED
Ketoconazole Shampoo, 2%, is a red-orange liquid supplied in a 4-fluid ounce nonbreakable plastic bottle (NDC 71713-097-04).
Storage conditions: Store at 20ºC to 25ºC (68ºF to 77ºF) [see USP Controlled Room Temperature]. Protect from light.
To report SUSPECTED ADVERSE REACTIONS contact Thirty Madison, Inc. at 1-833-745-3377 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Manufactured for: Thirty Madison, Inc.
New York, NY 10016
04006149 Rev. 1 11/22