Fluticasone Propionate
FLUTICASONE PROPIONATE CREAM, USP 0.05% FOR DERMATOLOGIC USE ONLY–NOT FOR OPHTHALMIC USE. Rx only
Approved
Approval ID
14c8d082-b301-8f09-a509-950459ae0a28
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 5, 2022
Manufacturers
FDA
Cosette Pharmaceuticals, Inc.
DUNS: 116918230
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0713-0631
Application NumberANDA077055
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fluticasone Propionate
Product Specifications
Route of AdministrationTOPICAL
Effective DateMay 5, 2022
FDA Product Classification
INGREDIENTS (10)
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
MINERAL OILInactive
Code: T5L8T28FGP
Classification: IACT
CETOSTEARYL ALCOHOLInactive
Code: 2DMT128M1S
Classification: IACT
CETETH-20Inactive
Code: I835H2IHHX
Classification: IACT
ISOPROPYL MYRISTATEInactive
Code: 0RE8K4LNJS
Classification: IACT
SODIUM PHOSPHATE, DIBASICInactive
Code: GR686LBA74
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
FLUTICASONE PROPIONATEActive
Quantity: 0.5 mg in 1 g
Code: O2GMZ0LF5W
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT