Ciclopirox
These highlights do not include all the information needed to use CICLOPIROX SHAMPOO safely and effectively. See full prescribing information for CICLOPIROX SHAMPOO. CICLOPIROX shampoo, for topical useInitial U.S. Approval: 1982
Approved
Approval ID
b44b190b-8e2a-4937-a6c5-92f37911e7f8
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 4, 2019
Manufacturers
FDA
Taro Pharmaceuticals U.S.A., Inc.
DUNS: 145186370
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
ciclopirox
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51672-1351
Application NumberANDA090269
Product Classification
M
Marketing Category
C73584
G
Generic Name
ciclopirox
Product Specifications
Route of AdministrationTOPICAL
Effective DateDecember 2, 2015
FDA Product Classification
INGREDIENTS (6)
disodium laureth sulfosuccinateInactive
Code: D6DH1DTN7E
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
laureth-2Inactive
Code: D4D38LT1L5
Classification: IACT
sodium laureth-3 sulfateInactive
Code: BPV390UAP0
Classification: IACT
sodium chlorideInactive
Code: 451W47IQ8X
Classification: IACT
ciclopiroxActive
Quantity: 10 mg in 0.96 mL
Code: 19W019ZDRJ
Classification: ACTIB