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 1% for topical useInitial U.S. Approval: 1982
Approved
Approval ID
4db19b1a-6c1a-159f-7d88-61429bbbcb56
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 5, 2018
Manufacturers
FDA
Teligent Pharma, Inc.
DUNS: 011036910
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 Code52565-032
Application NumberANDA209975
Product Classification
M
Marketing Category
C73584
G
Generic Name
ciclopirox
Product Specifications
Route of AdministrationTOPICAL
Effective DateSeptember 9, 2019
FDA Product Classification
INGREDIENTS (6)
waterInactive
Code: 059QF0KO0R
Classification: IACT
ciclopiroxActive
Quantity: 10 mg in 0.96 mL
Code: 19W019ZDRJ
Classification: ACTIB
sodium laureth-3 sulfateInactive
Code: BPV390UAP0
Classification: IACT
disodium laureth sulfosuccinateInactive
Code: D6DH1DTN7E
Classification: IACT
sodium chlorideInactive
Code: 451W47IQ8X
Classification: IACT
laureth-2Inactive
Code: D4D38LT1L5
Classification: IACT