LIDOCAINE 4% GEL PATCH patch

Lidocaine 4% Gel Patch by

Drug Labeling and Warnings

Lidocaine 4% Gel Patch by is a Otc medication manufactured, distributed, or labeled by Dr. Sabharwal's Wound Care. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Lidocaine 4%

INDICATIONS & USAGE

Temporarily Relieves Minor Pain

PURPOSE

Topical Anesthetic

WARNINGS

For external use only

DO NOT USE

• More than one patch on your body at a time
• On cut, irritated swollen skin
• On puncture wounds
• For more than one week without consulting a doctor
• At the same time as other topical analgesics

WHEN USING

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.

PREGNANCY 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.

INSTRUCTIONS FOR USE

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

STORAGE AND HANDLING

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

INACTIVE INGREDIENT

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

Questions? Call 718-739-5680

82349-2 - Section Title Not Found In Database

DOSAGE & ADMINISTRATION

Topical Patch for External Use Only

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LIDOCAINE 4% GEL PATCH 
lidocaine 4% gel patch patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71318-112
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	84 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	white	Score
Shape	RECTANGLE	Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71318-112-15	15 in 1 CARTON	08/10/2023
1		1 in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	08/10/2023

Labeler - Dr. Sabharwal's Wound Care (862184668)

Registrant - Dr. Sabharwal's Wound Care (862184668)

Establishment
Name	Address	ID/FEI	Business Operations
Dr. Sabharwal's Wound Care		862184668	manufacture(71318-112)