Ketoconazole by Zydus Lifesciences Limited KETOCONAZOLE shampoo

Ketoconazole by

Drug Labeling and Warnings

Ketoconazole by is a Prescription medication manufactured, distributed, or labeled by Zydus Lifesciences Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 70771-1874-7

Ketoconazole Shampoo, 2%

For Topical Application Only

4 FL OZ (120 mL)

Rx Only

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INGREDIENTS AND APPEARANCE

KETOCONAZOLE 
ketoconazole shampoo

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 70771-1874
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
KETOCONAZOLE (UNII: R9400W927I) (KETOCONAZOLE - UNII:R9400W927I)	KETOCONAZOLE	20 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
COCO DIETHANOLAMIDE (UNII: 92005F972D)
DISODIUM LAURETH SULFOSUCCINATE (UNII: D6DH1DTN7E)
FD&C RED NO. 40 (UNII: WZB9127XOA)
HYDROCHLORIC ACID (UNII: QTT17582CB)
IMIDUREA (UNII: M629807ATL)
PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70771-1874-7	120 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/08/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA218559	03/08/2025

Labeler - Zydus Lifesciences Limited (918596198)

Establishment
Name	Address	ID/FEI	Business Operations
Zydus Lifesciences Limited		650650802	ANALYSIS(70771-1874) , MANUFACTURE(70771-1874)