MedPath
FDA Approval

Flector

February 21, 2012

HUMAN PRESCRIPTION DRUG LABEL

Diclofenac(180 mg in 1 1)

Registrants (1)

PSS World Medical Inc.

101822682

Manufacturing Establishments (1)

STAT Rx USA LLC

STAT Rx USA LLC

PSS World Medical Inc.

786036330

Products (1)

Flector

42549-606

NDA021234

NDA (C73594)

TOPICAL

February 21, 2012

TARTARIC ACIDInactive
Code: W4888I119HClass: IACT
BUTYLENE GLYCOLInactive
Code: 3XUS85K0RAClass: IACT
DIHYDROXYALUMINUM AMINOACETATEInactive
Code: DO250MG0W6Class: IACT
Code: X5F8EKL9ZGClass: ACTIBQuantity: 180 mg in 1 1
EDETATE DISODIUMInactive
Code: 7FLD91C86KClass: IACT
KAOLINInactive
Code: 24H4NWX5COClass: IACT
GELATINInactive
Code: 2G86QN327LClass: IACT
METHYLPARABENInactive
Code: A2I8C7HI9TClass: IACT
POVIDONEInactive
Code: FZ989GH94EClass: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OHClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
CARBOXYMETHYLCELLULOSE SODIUMInactive
Code: K679OBS311Class: IACT
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