LIDOCAINE PAIN RELIEF GEL PATCH- lidocaine pain relief gel patch patch 
Twin MED LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Lidocaine Pain Relief Gel Patch

Active ingredient

Lidocaine 4%

Purpose

Topical Anesthetic

Use

Temporarily relieves minor pain

Warnings

For external use only

Do not use:
  • more than 1 patch on your body at a time
  • on cut, irritated or swollen skin
  • on puncture wounds
  • for more than one week without consulting a doctor
  • at the same time as other topical analgesics

When using this product:

• use only as directed.
• read and follow all directions and warnings on this label
• rare cases of serious burns have been reported with products of this type.
• do not apply to wounds or damaged, broken
• eyes and mucous membranes
• do not bandage tightly or apply local heat (such as
• the same time as other topical analgesics
• 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.
• a transient burning sensation may occur upon application but generally disappears in several days
• if a severe burning sensation occurs, discontinue use immediately.
• discontinue use at least 1 hour before a bath or shower.
• do not use immediately after a bath or shower.

Stop use and ask doctor if:

• condition worsen
• redness is present
• irritation develops
• symptoms persist for more than 7 days or clear up and occur again within a few days
• you experience signs of skin injury, such as pain, swelling, or blistering where this product is applied

if pregnant or breast feeding, 

ask a health professional before use.

keep out of reach of children and pets

If swallowed, get medical help or contact a Poison Control Center right away.

Directions:

Adult and children over 12years:

  • Clean and dry affected area
  • remove backing from patch by firmly grasping both ends and
  • gently pulling until back separates in middle
  • Carefully remove smaller portion of backing from the patch and apply exposed portion of
  • patch to affected area 
  • use 1 patch for up to 12 hours
children 12 years or younger: ask a doctor

Inactive ingredients:

Alpha Tocopherol, Aluminum Sulphate, Borax, Carbomer, Colloidal Silicon Dioxide, DMDM Hydantoin, Glycerin, Kaolin, Polyacrylic Acid, Polyvinyl Alcohol, Polyvinylpyrrolidone , Propylene Glycol, Purified Water, Sodium Carboxymethyl Cellulose, Sodium Ethylenediaminetetraacetic Acid, Sodium Polyacrylate, Sorbitol, Sorbitol Monooleate , Tartaric Acid & Titanium Dioxide

Other Information:

Store at room temperature 20·25'C (68-77'F)

Questions? call toll-free 1-844-912-4012

Package / Principle Label

Lidocaine Patch carton

LIDOCAINE PAIN RELIEF GEL PATCH 
lidocaine pain relief gel patch patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55681-501
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE40 mg
Inactive Ingredients
Ingredient NameStrength
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
ALUMINUM SULFATE (UNII: 34S289N54E)  
CARBOMER 934 (UNII: Z135WT9208)  
SODIUM BORATE (UNII: 91MBZ8H3QO)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
GLYCERIN (UNII: PDC6A3C0OX)  
KAOLIN (UNII: 24H4NWX5CO)  
POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)  
POLYVINYL ALCOHOL (100000 MW) (UNII: 949E52Z6MY)  
POVIDONE K27 (UNII: H7AGY1OJO8)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
MAGNESIUM DISODIUM EDTA (UNII: NDT563S5VZ)  
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
SORBITOL (UNII: 506T60A25R)  
SORBITOL MONOOLEATE (UNII: 658271J00C)  
TARTARIC ACID (UNII: W4888I119H)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorwhiteScore    
ShapeRECTANGLESize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55681-501-1515 in 1 BOX05/01/2023
11 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34805/01/2023
Labeler - Twin MED LLC (009579330)
Registrant - Twin MED LLC (009579330)
Establishment
NameAddressID/FEIBusiness Operations
DR. SABHARWAL'S WOUND CARE862184668manufacture(55681-501)

Revised: 4/2023
 
Twin MED LLC