PAIN RELIVEING PATCH- lidocaine 4% patch 
simple diagnostics

----------

Pain Relieving Patch

Drug Facts

LIDOCAINE PATCH 4%

Active Ingredient

Lidocaine 4%

Purpose

Topical anesthetic

USE

For the temporary relief of pain

Warnings

For external use only

Do not use more than 1 patch on vour bodv at a time on cut, irritated.or swolen skin on puncture wounds
for more than one week without consulting a doctor

When using this product

Use only as directed. Read and follow all directions and warnings on this carton. do not allow contact with the eyes
do not bandage tightly or apply local heat (such as heating pads) to the area of use do not use at the same time as other topical analcesics
dispose of used patch in manner that always keeps product away from children and pets. Used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch.

DO NOT USE:

STOP USE AND ASK A DOCTOR IF:

IF PREGNANT OR BREAST-FEEDING:

Ask a health professional before use

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away(1-800-222-1222).

Directions

Adults and children 12 years of age and older:
Wash and dry the affected area.
Peel off the backing film from one side of the patch carefully
Apply the exposed portion of the patch to the affected area.
Gently press the patch with your hand to fit the affected area completely.
Do not exercise vigorously during use to prevent the patch from falling off.
Use only 1 patch for a maximum of 8 hours.
Children under 12 years of age: Ask a doctor before use.

QUESTIONS OR COMMENTS:

Other information

Inactive ingredient

Dihydroxyaluminum Aminoacetate, Edetate Disodium, Glycerin, Kaolin, Methylparaben, Polysorbate 80, Propylene Glycol, Polyacrylic Acid, Povidone K90, Propylparaben, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Water.

PACKAGE LABEL. PRINCIPAL DISPLAY PANEL:

Pack of 30 PouchesPack of 5 PouchesPouch

PAIN RELIVEING PATCH 
lidocaine 4% patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62379-201
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE0.4 g
Inactive Ingredients
Ingredient NameStrength
KAOLIN (UNII: 24H4NWX5CO)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
POVIDONE K90 (UNII: RDH86HJV5Z)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)  
TARTARIC ACID (UNII: W4888I119H)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62379-201-0330 in 1 CASE06/01/2023
1NDC:62379-201-025 in 1 BOX
1NDC:62379-201-011 in 1 BAG; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01706/01/2023
Labeler - simple diagnostics (004135503)

Revised: 2/2024
Document Id: 0c7b516f-95da-5e49-e063-6394a90af0b9
Set id: 02ed0b27-bba9-ec0c-e063-6294a90a014d
Version: 8
Effective Time: 20240226
 
simple diagnostics