DailyMed - LIDOCAINE 4% PAIN RELIEF GEL PATCH patch

NDC Code(s): 55629-024-15
Packager: ONE2ZEE LIMITED LIABILITY COMPANY

Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated March 3, 2025

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

Download DRUG LABEL INFO: PDF XML
Official Label (Printer Friendly)

View All Sections

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 ...
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, Butylated Hydroxytoluene, Polysorbate

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

Questions? call toll-free 1-844-912-4012
Close
Package Label Box (What is this?)

Close

INGREDIENTS AND APPEARANCE

Product Information

LIDOCAINE 4% PAIN RELIEF GEL PATCH lidocaine 4% pain relief gel patch patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55629-024
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
ALUMINUM GLYCINATE (UNII: 1K713C615K)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM BORATE (UNII: 2C1HEM26VZ)
CARBOMER (UNII: 0A5MM307FC)
DMDM HYDANTOIN (UNII: BYR0546TOW)
ALUMINUM SULFATE (UNII: 34S289N54E)
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)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
POLYSORBATE 20 (UNII: 7T1F30V5YH)

Product Characteristics
Color	white	Score
Shape	RECTANGLE	Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:55629-024-15	15 in 1 BOX	03/03/2025
1		1 in 1 POUCH; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M	03/03/2025

Labeler - ONE2ZEE LIMITED LIABILITY COMPANY (078656111)

Registrant - ONE2ZEE LIMITED LIABILITY COMPANY (078656111)

Name	Address	ID/FEI	Business Operations
Establishment
DR. SABHARWAL'S WOUND CARE		862184668	manufacture(55629-024)

View All Sections

	RxCUI	RxNorm NAME	RxTTY
1	1737778	lidocaine 4 % Medicated Patch	PSN
2	1737778	lidocaine 0.04 MG/MG Medicated Patch	SCD
3	1737778	lidocaine 4 % Medicated Patch	SY

Label: LIDOCAINE 4% PAIN RELIEF GEL PATCH patch

View Package Photos

Drug Label Info

Safety

Related Resources

More Info For This Drug

Drug Label Information

Purpose

Use

Warnings

Do not use:

When using this product:

Find additional resources

Safety

Related Resources

More Info on this Drug

Label: LIDOCAINE 4% PAIN RELIEF GEL PATCH patch

View Package Photos

Drug Label Info

Safety

Related Resources

More Info For This Drug

Drug Label Information

Purpose

Use

Warnings

Do not use:

When using this product:

Find additional resources

Safety

Related Resources

More Info on this Drug

LIDOCAINE 4% PAIN RELIEF GEL PATCH patch

Number of versions: 1

LIDOCAINE 4% PAIN RELIEF GEL PATCH patch

LIDOCAINE 4% PAIN RELIEF GEL PATCH patch

To receive this label RSS feed

To receive all DailyMed Updates for the last seven days

What will I get with the DailyMed RSS feed?

How to discontinue the RSS feed

Why is DailyMed no longer displaying pill images on the Search Results and Drug Info pages?

LIDOCAINE 4% PAIN RELIEF GEL PATCH patch

If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.