Sernivo
These highlights do not include all the information needed to use SERNIVO™ Spray safely and effectively. See full prescribing information for SERNIVO™ Spray. SERNIVO™ (betamethasone dipropionate) spray, for topical use Initial U.S. Approval: 1975
Approved
Approval ID
21ca2c66-4ad1-4b6a-9c81-77d89eeb9edd
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 27, 2020
Manufacturers
FDA
Encore Dermatology Inc.
DUNS: 079629654
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
betamethasone dipropionate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69482-800
Application NumberNDA208079
Product Classification
M
Marketing Category
C73594
G
Generic Name
betamethasone dipropionate
Product Specifications
Route of AdministrationTOPICAL
Effective DateJuly 27, 2020
FDA Product Classification
INGREDIENTS (11)
BETAMETHASONE DIPROPIONATEActive
Quantity: 0.5 mg in 1 g
Code: 826Y60901U
Classification: ACTIM
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171K
Classification: IACT
CETOSTEARYL ALCOHOLInactive
Code: 2DMT128M1S
Classification: IACT
HYDROXYETHYL CELLULOSE, UNSPECIFIEDInactive
Code: T4V6TWG28D
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
MINERAL OILInactive
Code: T5L8T28FGP
Classification: IACT
OLEYL ALCOHOLInactive
Code: 172F2WN8DV
Classification: IACT
POLYOXYL 20 CETOSTEARYL ETHERInactive
Code: YRC528SWUY
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SORBITAN MONOSTEARATEInactive
Code: NVZ4I0H58X
Classification: IACT