VUSION
These highlights do not include all the information needed to use safely and effectively. See full prescribing information for . Initial U.S. Approval: 2006
Approved
Approval ID
b44b452d-3630-4cb5-8ed1-1f8edac4690c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 15, 2018
Manufacturers
FDA
Mylan Pharmaceuticals Inc.
DUNS: 059295980
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
miconazole nitrate, zinc oxide, white petrolatum
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0378-9730
Application NumberNDA021026
Product Classification
M
Marketing Category
C73594
G
Generic Name
miconazole nitrate, zinc oxide, white petrolatum
Product Specifications
Route of AdministrationTOPICAL
Effective DateAugust 15, 2018
FDA Product Classification
INGREDIENTS (5)
MICONAZOLE NITRATEActive
Quantity: 2.5 mg in 1 g
Code: VW4H1CYW1K
Classification: ACTIB
ZINC OXIDEActive
Quantity: 150 mg in 1 g
Code: SOI2LOH54Z
Classification: ACTIB
PETROLATUMActive
Quantity: 813.5 mg in 1 g
Code: 4T6H12BN9U
Classification: ACTIB
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171K
Classification: IACT
TRIHYDROXYSTEARINInactive
Code: 06YD7896S3
Classification: IACT