Lidocaine Patch 4%

Lidocaine Patch 4%
SPL v1
SPL
SPL Set ID b961906c-fe66-466b-af2c-072781fa098b
Route
TRANSDERMAL
Published
Effective Date 2025-04-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (40 mg)
Inactive Ingredients
Glycerin Polysorbate 80 Propylene Glycol Povidone, Unspecified Carboxymethylcellulose Sodium, Unspecified Kaolin Sodium Polyacrylate (8000 Mw) Tartaric Acid Carbomer Homopolymer, Unspecified Type Edetate Disodium Water Methylparaben

Identifiers & Packaging

Pill Appearance
Shape: rectangle
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-05-18

Description

Drug Facts

Purpose

Topical anesthetic


Medication Information

Purpose

Topical anesthetic

Description

Drug Facts

Drug Facts

Uses

For temporary relief of pain

Warnings

(​For external use only)

Directions

Adult and children 12 years of age and over:

  • clean and dry affected area
  • apply 1 patch at a time to affected area,not more than 3 to 4 times daily
  • remove patch from the skin after at most 8-hour application

Children under 12 years of age: consult a doctor

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
Active Ingredient

Lidocaine 4%

Other Information

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

Avoid storing product in direct sunlight and protect product from excessive moisture.

Inactive Ingredients

Glycerin, edetate disodium, tartaric acid. povidone K90. polysorbate80, propylene glycol, carboxymethylcellulose sodium, kaolin, carbomer, sodium polyacrylate,purified water. phenoxyethanol.

Principal Display Panel

NDC: 82461-416-30

Medcore LLC

Lidocaine Patch 4%

Pain Relieving Hydrogel Technology

Contains:

30 Patches

Manufactured for: Medcore LLC 3048 Valley Rd Basking Ridge, NJ 07920

Store in a dry, cool place for Comments or Questions, call 908-280-2269

When Using This Product
  • use only as directed
  • avoid contact with the eyes, mucous membranes or rashes
  • do not bandage tightly
Stop Use and Ask A Doctor If
  • localized skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blistering
  • condition worsen
  • symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days
If Pregnant 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.


Structured Label Content

Drug Facts

Uses

For temporary relief of pain

Purpose

Topical anesthetic

Warnings

(​For external use only)

Directions

Adult and children 12 years of age and over:

  • clean and dry affected area
  • apply 1 patch at a time to affected area,not more than 3 to 4 times daily
  • remove patch from the skin after at most 8-hour application

Children under 12 years of age: consult a doctor

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
Active Ingredient (Active ingredient)

Lidocaine 4%

Other Information (Other information)

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

Avoid storing product in direct sunlight and protect product from excessive moisture.

Inactive Ingredients (Inactive ingredients)

Glycerin, edetate disodium, tartaric acid. povidone K90. polysorbate80, propylene glycol, carboxymethylcellulose sodium, kaolin, carbomer, sodium polyacrylate,purified water. phenoxyethanol.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC: 82461-416-30

Medcore LLC

Lidocaine Patch 4%

Pain Relieving Hydrogel Technology

Contains:

30 Patches

Manufactured for: Medcore LLC 3048 Valley Rd Basking Ridge, NJ 07920

Store in a dry, cool place for Comments or Questions, call 908-280-2269

When Using This Product (When using this product)
  • use only as directed
  • avoid contact with the eyes, mucous membranes or rashes
  • do not bandage tightly
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • localized skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blistering
  • condition worsen
  • symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days
If Pregnant 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.


Advanced Ingredient Data


Raw Label Data

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