Label: LIDOCAINE patch
- NDC Code(s): 61919-779-30
- Packager: DIRECT RX
- This is a repackaged label.
- Source NDC Code(s): 0603-1880
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated March 28, 2016
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- DESCRIPTION
- CLINICAL PHARMACOLOGY
- CLINICAL STUDIES
- INDICATION AND USAGE
- CONTRAINDICATIONS
- WARNINGS
- Close PRECAUTIONS
- ADVERSE REACTIONS
- OVERDOSAGE
- DOSAGE AND ADMINISTRATION
- HANDLING AND DISPOSAL
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
LIDOCAINE
lidocaine patchProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:61919-779(NDC:0603-1880) Route of Administration CUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 700 mg Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:61919-779-30 30 in 1 CARTON; Type 0: Not a Combination Product 03/03/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA020612 03/03/2016 Labeler - DIRECT RX (079254320) Establishment Name Address ID/FEI Business Operations DIRECT RX 079254320 repack(61919-779)
