Clotrimazole and Betamethasone Dipropionate
These highlights do not include all the information needed to use CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM safely and effectively. See full prescribing information for CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM.CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE Cream, USP, for topical useInitial U.S. Approval: 1984
Approved
Approval ID
756180ee-4df5-4c02-8657-8d9882991036
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 5, 2021
Manufacturers
FDA
RPK Pharmaceuticals, Inc.
DUNS: 147096275
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Clotrimazole and Betamethasone Dipropionate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code53002-9740
Application NumberANDA202894
Product Classification
M
Marketing Category
C73584
G
Generic Name
Clotrimazole and Betamethasone Dipropionate
Product Specifications
Route of AdministrationTOPICAL
Effective DateMay 5, 2021
FDA Product Classification
INGREDIENTS (12)
BETAMETHASONE DIPROPIONATEActive
Quantity: 0.5 mg in 1 g
Code: 826Y60901U
Classification: ACTIM
CETOSTEARYL ALCOHOLInactive
Code: 2DMT128M1S
Classification: IACT
CLOTRIMAZOLEActive
Quantity: 10 mg in 1 g
Code: G07GZ97H65
Classification: ACTIB
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
CETEARETH-30Inactive
Code: 1R9DCZ5FOX
Classification: IACT
MINERAL OILInactive
Code: T5L8T28FGP
Classification: IACT
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEInactive
Code: 593YOG76RN
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
PHOSPHORIC ACIDInactive
Code: E4GA8884NN
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
PETROLATUMInactive
Code: 4T6H12BN9U
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT