Cortisporin
Approved
Approval ID
e86a5293-312d-4425-bf95-35e4d7149aed
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 30, 2010
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
neomycin sulfate, polymyxin B sulfate and hydrocortisone acetate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-1531
Application NumberNDA050218
Product Classification
M
Marketing Category
C73594
G
Generic Name
neomycin sulfate, polymyxin B sulfate and hydrocortisone acetate
Product Specifications
Route of AdministrationTOPICAL
Effective DateDecember 30, 2010
FDA Product Classification
INGREDIENTS (8)
NEOMYCIN SULFATEActive
Quantity: 3.5 mg in 1 g
Code: 057Y626693
Classification: ACTIB
POLYMYXIN B SULFATEActive
Quantity: 10000 U in 1 g
Code: 19371312D4
Classification: ACTIB
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROCORTISONE ACETATEActive
Quantity: 5 mg in 1 g
Code: 3X7931PO74
Classification: ACTIB
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
LIGHT MINERAL OILInactive
Code: N6K5787QVP
Classification: IACT
PETROLATUMInactive
Code: 4T6H12BN9U
Classification: IACT