Ertaczo
These highlights do not include all the information needed to use ERTACZO Cream safely and effectively. See full prescribing information for ERTACZO Cream.ERTACZO (sertaconazole nitrate) cream, for topical useInitial U.S. Approval: 2003
Approved
Approval ID
821073f7-33f6-464d-baed-f66d97987d6d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 18, 2020
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.
Sertaconazole Nitrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0187-5115
Application NumberNDA021385
Product Classification
M
Marketing Category
C73594
G
Generic Name
Sertaconazole Nitrate
Product Specifications
Route of AdministrationTOPICAL
Effective DateDecember 18, 2020
FDA Product Classification
INGREDIENTS (10)
Light Mineral OilInactive
Code: N6K5787QVP
Classification: IACT
Ethylene GlycolInactive
Code: FC72KVT52F
Classification: IACT
Sorbic AcidInactive
Code: X045WJ989B
Classification: IACT
MethylparabenInactive
Code: A2I8C7HI9T
Classification: IACT
PEG-6 STEARATEInactive
Code: 8LQC57C6B0
Classification: IACT
GLYCOL STEARATEInactive
Code: 0324G66D0E
Classification: IACT
Sertaconazole NitrateActive
Quantity: 20 mg in 1 g
Code: 1DV05410M5
Classification: ACTIB
Glyceryl IsostearateInactive
Code: HYE7O27HAO
Classification: IACT
PEG-32 STEARATEInactive
Code: 33GX5WQC0M
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT