Fluticasone Propionate
These highlights do not include all the information needed to use FLUTICASONE PROPIONATE LOTION safely and effectively. See full prescribing information for FLUTICASONE PROPIONATE LOTION. FLUTICASONE PROPIONATE Lotion, for topical use Initial U.S. Approval: 1990
Approved
Approval ID
3c7b3482-e2fd-4857-9394-a47fd7f4c47b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 1, 2020
Manufacturers
FDA
Glenmark Pharmaceuticals Inc., USA
DUNS: 130597813
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Fluticasone Propionate
PRODUCT DETAILS
NDC Product Code68462-427
Application NumberANDA090759
Marketing CategoryC73584
Route of AdministrationTOPICAL
Effective DateFebruary 1, 2020
Generic NameFluticasone Propionate
INGREDIENTS (14)
CETOSTEARYL ALCOHOLInactive
Code: 2DMT128M1S
Classification: IACT
FLUTICASONE PROPIONATEActive
Quantity: 0.5 mg in 1 mL
Code: O2GMZ0LF5W
Classification: ACTIB
POLYOXYL 20 CETOSTEARYL ETHERInactive
Code: YRC528SWUY
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
DIMETHICONE 350Inactive
Code: 2Y53S6ATLU
Classification: IACT
LIGHT MINERAL OILInactive
Code: N6K5787QVP
Classification: IACT
ANHYDROUS TRISODIUM CITRATEInactive
Code: RS7A450LGA
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
ISOPROPYL MYRISTATEInactive
Code: 0RE8K4LNJS
Classification: IACT
SORBITAN MONOSTEARATEInactive
Code: NVZ4I0H58X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
IMIDUREAInactive
Code: M629807ATL
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT