LIDOCAINE 4% GEL PATCH- lidocaine 4% gel patch patch 
Dr. Sabharwal's Wound Care

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 4%

Temporarily Relieves Minor Pain

Topical Anesthetic

For external use only

Use only as directed.
Read and follow all directions and warnings on this label.
Rare case of serious burns have been reported with products of this type.
Do not apply to wounds or damaged, broken or irritated skin.
Do not allow contact with the eyes and mucous membranes.
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 analgesic.
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
A transient burning sensation may occur uopn 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 a doctor if

Condition worsens
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 the product was applied.

ask a health professional before use.

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

Adult and children over 12 years
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

Store at room temperature 20-25 0C (68-77 0F)

Alpha Tocopherol Acetate, Aluminium Glycinate, Aluminium Hydroxide, Aluminium Sulphate, Borax, Carbomer, Collodial Silicon
Dioxide, DMDM Hydantoin, Glycerine, Kaolin, Polyacrylic Acid, Polyvinyl Alcohol, Polyvinylpyrrolidone, Propylene Glycol, Purified Water, Sodium Carboxymethyl Cellulose, Sodium Ethylenediaminetetraacetic Acid, Sodium Polyacrylate, Sorbitol, Sorbitan Monooleate, Tartaric Acid & Titanium Dioxide.

Questions? Call 718-739-5680

Topical Patch for External Use Only

Lidocaine Patch

LIDOCAINE 4% GEL PATCH 
lidocaine 4% gel patch patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71318-112
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE84 mg
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
GLYCERIN (UNII: PDC6A3C0OX)  
KAOLIN (UNII: 24H4NWX5CO)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
CARBOMER 940 (UNII: 4Q93RCW27E)  
POLYVINYL ALCOHOL (100000 MW) (UNII: 949E52Z6MY)  
SORBITOL (UNII: 506T60A25R)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
TARTARIC ACID (UNII: W4888I119H)  
Product Characteristics
ColorwhiteScore    
ShapeRECTANGLESize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71318-112-1515 in 1 CARTON08/10/2023
11 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34808/10/2023
Labeler - Dr. Sabharwal's Wound Care (862184668)
Registrant - Dr. Sabharwal's Wound Care (862184668)
Establishment
NameAddressID/FEIBusiness Operations
Dr. Sabharwal's Wound Care862184668manufacture(71318-112)

Revised: 8/2023
Document Id: 0407e25d-0c9d-217a-e063-6394a90ad2d3
Set id: 026629b4-9df9-1d43-e063-6394a90a48a3
Version: 3
Effective Time: 20230828
 
Dr. Sabharwal's Wound Care