Antifungal Cream
Antifungal Cream Miconazole Nitrate Cream, USP 2%
Approved
Approval ID
8be4bbfa-424c-4ccf-b8bc-65b16c126053
Product Type
HUMAN OTC DRUG LABEL
Effective Date
Mar 6, 2025
Manufacturers
FDA
Encube Ethicals Private Limited
DUNS: 915834105
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Miconazole Nitrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code21922-095
Application NumberM005
Product Classification
M
Marketing Category
C200263
G
Generic Name
Miconazole Nitrate
Product Specifications
Route of AdministrationTOPICAL
Effective DateMarch 6, 2025
FDA Product Classification
INGREDIENTS (7)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
MICONAZOLE NITRATEActive
Quantity: 2 g in 100 g
Code: VW4H1CYW1K
Classification: ACTIB
BENZOIC ACIDInactive
Code: 8SKN0B0MIM
Classification: IACT
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2U
Classification: IACT
MINERAL OILInactive
Code: T5L8T28FGP
Classification: IACT
APRICOT KERNEL OIL PEG-6 ESTERSInactive
Code: DRG3KJZ1TJ
Classification: IACT
PEGOXOL 7 STEARATEInactive
Code: 3EW5AXE5X5
Classification: IACT