Hydrocortisone Butyrate
These highlights do not include all the information needed to use HYDROCORTISONE BUTYRATE CREAM (lipid), 0.1% safely and effectively. See full prescribing information for HYDROCORTISONE BUTYRATE CREAM (lipid), 0.1%. HYDROCORTISONE BUTYRATE CREAM (lipid), 0.1%, for topical use Initial U.S. Approval: 1982
Approved
Approval ID
ddf699f4-1ae0-48c3-8d2a-56aa1a2c5bc1
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 31, 2021
Manufacturers
FDA
Oceanside Pharmaceuticals
DUNS: 832011691
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
HYDROCORTISONE BUTYRATE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68682-384
Application NumberNDA020769
Product Classification
M
Marketing Category
C73605
G
Generic Name
HYDROCORTISONE BUTYRATE
Product Specifications
Route of AdministrationTOPICAL
Effective DateMarch 31, 2021
FDA Product Classification
INGREDIENTS (10)
BUTYLPARABENInactive
Code: 3QPI1U3FV8
Classification: IACT
MINERAL OILInactive
Code: T5L8T28FGP
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
SODIUM CITRATE, UNSPECIFIED FORMInactive
Code: 1Q73Q2JULR
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
CETETH-20Inactive
Code: I835H2IHHX
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PETROLATUMInactive
Code: 4T6H12BN9U
Classification: IACT
CETOSTEARYL ALCOHOLInactive
Code: 2DMT128M1S
Classification: IACT
HYDROCORTISONE BUTYRATEActive
Quantity: 1 mg in 1 g
Code: 05RMF7YPWN
Classification: ACTIB