LIDOCAINE- lidocaine patch 
DIRECT RX

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LIDOCAINE PATCH 5%

DESCRIPTION

CLINICAL PHARMACOLOGY

CLINICAL STUDIES

INDICATION AND USAGE

CONTRAINDICATIONS

WARNINGS

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PRECAUTIONS

ADVERSE REACTIONS

OVERDOSAGE

DOSAGE AND ADMINISTRATION

HANDLING AND DISPOSAL

PRINCIPAL DISPLAY PANEL

LIDOCAINE PATCH

LIDOCAINE 
lidocaine patch
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:61919-779(NDC:0603-1880)
Route of AdministrationCUTANEOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE700 mg
Inactive Ingredients
Ingredient NameStrength
UREA (UNII: 8W8T17847W)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYVINYL ALCOHOL (UNII: 532B59J990)  
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
GELATIN (UNII: 2G86QN327L)  
SORBITOL (UNII: 506T60A25R)  
POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)  
TARTARIC ACID (UNII: W4888I119H)  
KAOLIN (UNII: 24H4NWX5CO)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61919-779-3030 in 1 CARTON; Type 0: Not a Combination Product03/03/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02061203/03/2016
Labeler - DIRECT RX (079254320)
Establishment
NameAddressID/FEIBusiness Operations
DIRECT RX079254320repack(61919-779)

Revised: 3/2016
Document Id: 2f1e77e1-86b7-635e-e054-00144ff88e88
Set id: 2f1e77e1-86b6-635e-e054-00144ff88e88
Version: 1
Effective Time: 20160328
 
DIRECT RX