Loprox
These highlights do not include all the information needed to use LOPROX Shampoo safely and effectively. See full prescribing information for LOPROX Shampoo. LOPROX (ciclopirox) shampoo, for topical useInitial U.S. Approval: 1982
Approved
Approval ID
464a1be3-b72b-424d-b11b-a8f26126cce7
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 1, 2019
Manufacturers
FDA
Bausch Health US, LLC
DUNS: 831922468
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 Code99207-010
Application NumberNDA021159
Product Classification
M
Marketing Category
C73594
G
Generic Name
ciclopirox
Product Specifications
Route of AdministrationTOPICAL
Effective DateMay 1, 2019
FDA Product Classification
INGREDIENTS (6)
ciclopiroxActive
Quantity: 10 mg in 0.96 mL
Code: 19W019ZDRJ
Classification: ACTIB
disodium laureth sulfosuccinateInactive
Code: D6DH1DTN7E
Classification: IACT
laureth-2Inactive
Code: D4D38LT1L5
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
sodium chlorideInactive
Code: 451W47IQ8X
Classification: IACT
sodium laureth-3 sulfateInactive
Code: BPV390UAP0
Classification: IACT