Maximum Strength

Maximum Strength
SPL v8
SPL
SPL Set ID 963978de-8295-47ee-9b06-64c3521aa994
Route
TOPICAL
Published
Effective Date 2026-02-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (560 mg)
Inactive Ingredients
Dihydroxyaluminum Aminoacetate Edetate Disodium Gelatin Glycerin Kaolin Methylparaben Polyacrylic Acid (250000 Mw) Polyvinyl Alcohol (100000 Mw) Propylene Glycol Propylparaben Carboxymethylcellulose Sodium, Unspecified Sodium Polyacrylate (2500000 Mw) Sorbitol Tartaric Acid Urea Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2023-04-03 Until 2026-02-28

Description

Lidocaine 4%

Purpose

Topical anesthetic


Medication Information

Purpose

Topical anesthetic

Description

Lidocaine 4%

Uses

Temporary relief of pain

Directions

Adults and children over 12 years:

  • clean and dry affected area
  • remove film from patch and apply to the skin
  • apply one patch to affected area not more than 3 to 4 times a day
  • remove patch from the skin after at most 12-hour application

Children under 12 years of age: consult a doctor

Do Not Use
  • more than one patch at a time
  • on wounds or damaged, broken or irritated skin
  • if you are allergic to any ingredients of this product

Distributed By

  MADE IN JAPAN

C09750050222 R02/22

Active Ingredient(s)

Lidocaine 4%

Inactive Ingredients

dihydroxyaluminum aminoacetate, disodium edetate, gelatin, glycerin, kaolin, methylparaben, polyacrylic acid, polyvinyl

alcohol, propylene glycol, propylparaben, sodium carboxymethylcellulose, sodium polyacrylate, D-sorbitol, tartaric acid, urea, water

Comments Or Questions:

1-800-845-8210

††This product is not manufactured or distributed by Chattem, Inc., distributor of Aspercreme® Lidocaine Patch.

Principal Display Panel
lidocaine patch
When Using This Product
  • use only as directed          • read and follow all directions and warnings

  • do not allow contact with eyes and mucous membranes

  • do not bandage tightly      • do not apply local heat such as a heating pad
  • do not use other topical anesthetics at the same time

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

Keep Out of Reach of Children

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

If Pregnant Or Breast Feeding, 

ask a healthcare professional before use.

Principal Display Panel 30 Patches

NDC 0121-0970-30

Lidocaine Pain Relief Patch

4% Lidocaine / Topical Anesthetic


Structured Label Content

Uses

Temporary relief of pain

Purpose

Topical anesthetic

Directions

Adults and children over 12 years:

  • clean and dry affected area
  • remove film from patch and apply to the skin
  • apply one patch to affected area not more than 3 to 4 times a day
  • remove patch from the skin after at most 12-hour application

Children under 12 years of age: consult a doctor

Do Not Use (Do not use)
  • more than one patch at a time
  • on wounds or damaged, broken or irritated skin
  • if you are allergic to any ingredients of this product

Distributed By (Distributed by)

  MADE IN JAPAN

C09750050222 R02/22

Active Ingredient(s) (Active ingredient(s))

Lidocaine 4%

Inactive Ingredients (Inactive ingredients)

dihydroxyaluminum aminoacetate, disodium edetate, gelatin, glycerin, kaolin, methylparaben, polyacrylic acid, polyvinyl

alcohol, propylene glycol, propylparaben, sodium carboxymethylcellulose, sodium polyacrylate, D-sorbitol, tartaric acid, urea, water

Comments Or Questions: (Comments or Questions:)

1-800-845-8210

††This product is not manufactured or distributed by Chattem, Inc., distributor of Aspercreme® Lidocaine Patch.

Principal Display Panel
lidocaine patch
When Using This Product (When using this product)
  • use only as directed          • read and follow all directions and warnings

  • do not allow contact with eyes and mucous membranes

  • do not bandage tightly      • do not apply local heat such as a heating pad
  • do not use other topical anesthetics at the same time

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

  • conditions worsen

  • symptoms persist for more than 7 days

  • symptoms clear up and occur again within a few days

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.

If Pregnant Or Breast Feeding,  (if pregnant or breast-feeding, )

ask a healthcare professional before use.

Principal Display Panel 30 Patches (Principal Display Panel - 30 patches)

NDC 0121-0970-30

Lidocaine Pain Relief Patch

4% Lidocaine / Topical Anesthetic


Advanced Ingredient Data


Raw Label Data

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