Pramosone
Pramosone Ointment (hydrocortisone acetate and pramoxine hydrochloride)
Approved
Approval ID
b955de80-3bb5-11e5-ac7f-0002a5d5c51b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 15, 2017
Manufacturers
FDA
Sebela Pharmaceuticals Inc.
DUNS: 079104574
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
hydrocortisone acetate and pramoxine hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54766-777
Product Classification
G
Generic Name
hydrocortisone acetate and pramoxine hydrochloride
Product Specifications
Route of AdministrationTOPICAL
Effective DateDecember 15, 2017
FDA Product Classification
INGREDIENTS (5)
SORBITAN SESQUIOLEATEInactive
Code: 0W8RRI5W5A
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PETROLATUMInactive
Code: 4T6H12BN9U
Classification: IACT
HYDROCORTISONE ACETATEActive
Quantity: 25 mg in 1 g
Code: 3X7931PO74
Classification: ACTIB
PRAMOXINE HYDROCHLORIDEActive
Quantity: 10 mg in 1 g
Code: 88AYB867L5
Classification: ACTIB