VOLTAREN
These highlights do not include all the information needed to use Voltaren® Gel safely and effectively. See full prescribing information for Voltaren® Gel.Initial U.S. Approval: 1988
Approved
Approval ID
e1685937-3980-40e3-8f04-998174fef3a2
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 23, 2012
Manufacturers
FDA
STAT Rx USA LLC
DUNS: 786036330
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
diclofenac sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42549-627
Application NumberNDA022122
Product Classification
M
Marketing Category
C73594
G
Generic Name
diclofenac sodium
Product Specifications
Route of AdministrationTOPICAL
Effective DateFebruary 23, 2012
FDA Product Classification
INGREDIENTS (8)
DICLOFENAC SODIUMActive
Quantity: 10 mg in 1 g
Code: QTG126297Q
Classification: ACTIB
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
CARBOMER HOMOPOLYMER TYPE CInactive
Code: 4Q93RCW27E
Classification: IACT
MINERAL OILInactive
Code: T5L8T28FGP
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
POLYOXYL 20 CETOSTEARYL ETHERInactive
Code: YRC528SWUY
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT