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
26b2d99e-d471-4758-8aa0-a26ef464eb35
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 6, 2011
Manufacturers
FDA
Keltman Pharmaceuticals Inc.
DUNS: 362861077
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 Code68387-456
Application NumberNDA022122
Product Classification
M
Marketing Category
C73594
G
Generic Name
diclofenac sodium
Product Specifications
Route of AdministrationTOPICAL
Effective DateJune 6, 2011
FDA Product Classification
INGREDIENTS (8)
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
DICLOFENAC SODIUMActive
Quantity: 10 mg in 1 g
Code: QTG126297Q
Classification: ACTIB
CARBOMER HOMOPOLYMER TYPE CInactive
Code: 4Q93RCW27E
Classification: IACT
MINERAL OILInactive
Code: T5L8T28FGP
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
POLYOXYL 20 CETOSTEARYL ETHERInactive
Code: YRC528SWUY
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT