Flector
Flector® Patch (diclofenac epolamine topical patch) 1.3%
Approved
Approval ID
2cc5e92b-044b-46a4-85eb-bcfe04c9d4be
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 21, 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 epolamine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42549-606
Application NumberNDA021234
Product Classification
M
Marketing Category
C73594
G
Generic Name
Diclofenac epolamine
Product Specifications
Route of AdministrationTOPICAL
Effective DateFebruary 21, 2012
FDA Product Classification
INGREDIENTS (15)
TARTARIC ACIDInactive
Code: W4888I119H
Classification: IACT
BUTYLENE GLYCOLInactive
Code: 3XUS85K0RA
Classification: IACT
DIHYDROXYALUMINUM AMINOACETATEInactive
Code: DO250MG0W6
Classification: IACT
DICLOFENAC EPOLAMINEActive
Quantity: 180 mg in 1 1
Code: X5F8EKL9ZG
Classification: ACTIB
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
KAOLINInactive
Code: 24H4NWX5CO
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
CARBOXYMETHYLCELLULOSE SODIUMInactive
Code: K679OBS311
Classification: IACT