Pramosone
Pramosone Lotion (hydrocortisone acetate and pramoxine hydrochloride)
Approved
Approval ID
f207bdff-2f41-4eee-818e-198b6462863e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 18, 2018
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 Code54766-729
Application NumberANDA085980
Product Classification
M
Marketing Category
C73584
G
Generic Name
hydrocortisone acetate and pramoxine hydrochloride
Product Specifications
Route of AdministrationTOPICAL
Effective DateDecember 18, 2018
FDA Product Classification
INGREDIENTS (18)
LANOLINInactive
Code: 7EV65EAW6H
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
DIISOPROPYL ADIPATEInactive
Code: P7E6YFV72X
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROCORTISONE ACETATEActive
Quantity: 10 mg in 1 mL
Code: 3X7931PO74
Classification: ACTIB
HYDROGENATED COCONUT OILInactive
Code: JY81OXM1OM
Classification: IACT
SORBITAN SESQUIOLEATEInactive
Code: 0W8RRI5W5A
Classification: IACT
STEARYL ALCOHOLInactive
Code: 2KR89I4H1Y
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
TROLAMINEInactive
Code: 9O3K93S3TK
Classification: IACT
CETYL ALCOHOLInactive
Code: 936JST6JCN
Classification: IACT
PETROLATUMInactive
Code: 4T6H12BN9U
Classification: IACT
POLYOXYL 40 STEARATEInactive
Code: 13A4J4NH9I
Classification: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
POTASSIUM SORBATEInactive
Code: 1VPU26JZZ4
Classification: IACT
SORBIC ACIDInactive
Code: X045WJ989B
Classification: IACT
PRAMOXINE HYDROCHLORIDEActive
Quantity: 10 mg in 1 mL
Code: 88AYB867L5
Classification: ACTIB