LIDOCAINE PAIN RELIEVING PATCH- lidocaine 4% patch

Lidocaine Pain Relieving Patch by

Drug Labeling and Warnings

Lidocaine Pain Relieving Patch by is a Otc medication manufactured, distributed, or labeled by BluePoint Laboratories, WOOSHIN LAPACHE d.o.o.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Lidocaine 4%

Purpose

Topical anesthetic

Uses

For the temporary relief of pain

Warnings:

For external use only.

Do not Use

• On wounds or damaged skin
• With a heating pad
• If you are allergic to any ingredients of this product

When Using This Product

• Use only as directed
• Do not bandage tightly
• Avoid contact with the eyes, mucous membranes or rashes
• Do not apply to open wounds or damaged skin

Stop Use and Ask a Doctor if

• Condition worsens
• Symptoms persist for more than 7 days or clears up and occurs again within a few days
• Severe burning sensation, redness or irritation develops
• You experience signs of skin injury, such as pain, swelling, or blistering where the product was applied

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

Directions:

Adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily.

Children under 12 years of age: do not use, consult a physician.

• Clean and dry affected area
• Remove the film from the patch and apply to the affected area
• Use 1 patch at a time and not more than 3 to 4 times daily
• Remove patch from the skin after at most 8 hours application

Other information

• Do not use if the pouch is opened or damaged
• Tighlty reseal the pouch containing unused patches
• Store at room temperature
• Do not freeze
• This package is child-resistant

Inactive ingredients

Carboxymethylcellulose sodium, Dihydroxyaluminum aminoacetate, Edetate sodium, Glycerin, Methyl parahydroxybenzoate (Methylparaben), Partially neutralized Sodium Polyacrylate, Polyacrylic acid, Polysorbate 80, Propyl parahydroxybenzoate (Propylparaben), Propylene glycol, Sodium Polyacrylate, Tartaric acid, Titanium dioxide, Water.

Questions or comments?

Call toll-free 1-800-655-0252 or email: wooshinlabo-us@wooshinmed.com

Principal Display Panel

Lidocaine Pain Relieving Patch Pouch 4%

NDC: 68001-625-89

Rev 05/25

Lidocaine Pain Relieving Patch 5 Patch Carton 4%

NDC: 68001-625-93

Rev 08/25

Lidocaine Pain Relieving Patch 30 Patch Carton 4%

NDC: 68001-625-95

Rev 08/25

INGREDIENTS AND APPEARANCE

LIDOCAINE PAIN RELIEVING PATCH 
lidocaine 4% patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68001-625
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
TARTARIC ACID (UNII: W4888I119H)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K)
METHYLPARABEN (UNII: A2I8C7HI9T)
EDETATE SODIUM (UNII: MP1J8420LU)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68001-625-93	5 in 1 BOX	09/19/2025
1	NDC: 68001-625-89	1 g in 1 PATCH; Type 0: Not a Combination Product
2	NDC: 68001-625-95	30 in 1 BOX	09/18/2025
2	NDC: 68001-625-89	1 g in 1 PATCH; 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	09/18/2025

Labeler - BluePoint Laboratories (985523874)

Establishment
Name	Address	ID/FEI	Business Operations
WOOSHIN LAPACHE d.o.o.		507385209	manufacture(68001-625)