LIDOCAINE 4% PATCH- lidocaine 4% patch

Lidocaine 4% Patch by

Drug Labeling and Warnings

Lidocaine 4% Patch by is a Otc medication manufactured, distributed, or labeled by Oncora Pharma, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Lidocaine 4%

Purpose

Topical Anesthetic

Uses

Temporarily relieves pain and itching associated with: minor burns, sunburn, minor cuts, scrapes, insect bites, minor skin irritations.

Warnings

For external use only

DO NOT USE

Do not use:

• More than 1 patch at a time
• On wounds or damaged skin
• With a heating pad
• If you are allergic to any ingredients of this product

WHEN USING

When using this product:

• Use only as directed
• Avoid contact with the eyes, mucous membranes, or rashes
• Do not bandage tightly

STOP USE

Stop use and ask a doctor if:

• Localized skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blistering
• Conditions worsen
• Symptoms persist for more than 7 days
• Symptoms clear up and occur again within a few days

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding,ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adults and children 12 years of age or over:

Apply 1 patch to the affected area of intact skin up to 3 times a day. Do not leave patch on for more than 8 hours at a time.

• Clean and dry the affected area
• Open pouch and remove one patch
• Remove any protective film and apply directly to affected area of pain
• Apply immediately after the removal of the protective envelope
• Wash hands with soap and water after handling the patches
• Reseal pouch containing unused patches after each use. Do not store patch outside the sealed envelope.
• Fold used patches so that the adhesive side sticks to itself and safely discard used patches or pieces of cut patches where children and pets cannot get to them.

Children under 12 years of age:Ask a physician

Other Information

Store at room temperature 15° - 30° C (59° - 86° F)

• Avoid storing product in direct sunlight
• Protect product from excessive moisture

Other Ingredients

Acrylic Adhesive, Flaxseed oil, and Polysorbate 80

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LIDOCAINE 4% PATCH 
lidocaine 4% patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85477-302
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	40 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
FLAX SEED (UNII: 4110YT348C)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
ACRYLIC ACID (UNII: J94PBK7X8S)

Product Characteristics
Color		Score
Shape	RECTANGLE (White Flexible Patch)	Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85477-302-10	10 in 1 BOX	06/11/2025
1		1 g 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 Drug	M017	06/11/2025

Labeler - Oncora Pharma, LLC (119482542)