FLECTOR- diclofenac epolamine patch 
Altergon Italia Srl

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Flector

PRINCIPAL DISPLAY PANEL - 1.3% Carton

NDC 43328-005-30

FLECTOR ® PATCH

(diclofenac epolamine topical patch)

1.3%

R x Only

30 PATCHES (10 CM X 14 CM EACH)

Dispense with enclosed Medication Guide

Change patch once every 12 hours.

Fold used patches so that the adhesive side sticks to itself and safely
discard used patches where children and pets cannot get to them.

IBSA

Pfizer Inc.

PRINCIPAL DISPLAY PANEL

FLECTOR 
diclofenac epolamine patch
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:43328-005
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DICLOFENAC EPOLAMINE (UNII: X5F8EKL9ZG) (DICLOFENAC - UNII:144O8QL0L1) DICLOFENAC EPOLAMINE13 mg
Inactive Ingredients
Ingredient NameStrength
SORBITOL (UNII: 506T60A25R)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
TARTARIC ACID (UNII: W4888I119H)  
KAOLIN (UNII: 24H4NWX5CO)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
POVIDONE (UNII: FZ989GH94E)  
WATER (UNII: 059QF0KO0R)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
GELATIN (UNII: 2G86QN327L)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorwhiteScore    
ShapeRECTANGLESize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43328-005-055 in 1 POUCH; Type 0: Not a Combination Product01/14/2008
2NDC:43328-005-306 in 1 CARTON01/14/2008
2NDC:43328-005-055 in 1 POUCH; Type 0: Not a Combination Product
3NDC:43328-005-021 in 1 CARTON01/14/2008
3NDC:43328-005-002 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Approved Drug Product Manufactured Under ContractNDA02123401/14/2008
Labeler - Altergon Italia Srl (458276941)
Registrant - Altergon Italia Srl (458276941)

Revised: 1/2018
Document Id: 629b168d-cb20-0d97-e053-2a91aa0a5f95
Set id: 50e44bda-0438-4998-a37e-9b404e0c29ff
Version: 2
Effective Time: 20180123
 
Altergon Italia Srl