Oxistat
OXISTAT (oxiconazole nitrate cream) Cream, 1%* OXISTAT (oxiconazole nitrate lotion) Lotion, 1%*
Approved
Approval ID
094d5b1e-ccf6-4384-b208-fd70360ffda2
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 30, 2009
Manufacturers
FDA
Rebel Distributors Corp.
DUNS: 118802834
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
oxiconazole nitrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code21695-459
Application NumberNDA020209
Product Classification
M
Marketing Category
C73594
G
Generic Name
oxiconazole nitrate
Product Specifications
Route of AdministrationTOPICAL
Effective DateOctober 29, 2009
FDA Product Classification
INGREDIENTS (8)
waterInactive
Code: 059QF0KO0R
Classification: IACT
cetyl alcoholInactive
Code: 936JST6JCN
Classification: IACT
benzoic acidInactive
Code: 8SKN0B0MIM
Classification: IACT
oxiconazole nitrateActive
Quantity: 30 mg in 1 g
Code: RQ8UL4C17S
Classification: ACTIB
petrolatumInactive
Code: 4T6H12BN9U
Classification: IACT
stearyl alcoholInactive
Code: 2KR89I4H1Y
Classification: IACT
propylene glycolInactive
Code: 6DC9Q167V3
Classification: IACT
polysorbate 60Inactive
Code: CAL22UVI4M
Classification: IACT