Ecoza
These highlights do not include all the information needed to use ECOZA safely and effectively. See full prescribing information for ECOZA. ECOZA (econazole nitrate) topical foam, 1%, for topical use Initial U.S. Approval: 1982
Approved
Approval ID
0bb5fa27-32ed-ed13-e063-6394a90a1577
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 4, 2023
Manufacturers
FDA
Resilia Pharmaceuticals, Inc.
DUNS: 117711487
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
econazole nitrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code81811-100
Application NumberNDA205175
Product Classification
M
Marketing Category
C73594
G
Generic Name
econazole nitrate
Product Specifications
Route of AdministrationTOPICAL
Effective DateDecember 4, 2023
FDA Product Classification
INGREDIENTS (10)
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
TROLAMINEInactive
Code: 9O3K93S3TK
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
BUTANEInactive
Code: 6LV4FOR43R
Classification: IACT
ECONAZOLE NITRATEActive
Quantity: 10 mg in 1 g
Code: H438WYN10E
Classification: ACTIB
POLYSORBATE 20Inactive
Code: 7T1F30V5YH
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT