Maximum Strength 4% Lidocaine Patch

Maximum Strength 4% Lidocaine Patch
SPL v3
SPL
SPL Set ID 3061d301-2104-b1b2-e063-6394a90a9b6e
Route
TOPICAL
Published
Effective Date 2025-03-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (40 mg)
Inactive Ingredients
Povidone K90 Polysorbate 80 Tartaric Acid Titanium Dioxide Polyacrylic Acid (250000 Mw) Dihydroxyaluminum Aminoacetate Glycerin Edetate Disodium Anhydrous Methylparaben Sodium Polyacrylate (2500000 Mw) Propylene Glycol Kaolin Propylparaben Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-03-01

Description

Lidocaine 4%

Purpose

Topical Anesthetic


Medication Information

Purpose

Topical Anesthetic

Description

Lidocaine 4%

Uses

for temporary relief of pain

Warnings

For external use only

Directions

Adults and children 12 years of age and over:

  • clean and dry affected area
  • remove backing layer from patch and apply to the affected area (see pictorial representation)
  • remove patch from the skin after at most 8-hour application
  • apply to affected area not more than 3 to 4 times daily

children under 12 years of age: consult a doctor

Do Not Use
  • more than one 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 20-25°C (68-77°F)
  • protect product from direct sunlight and excessive moisture

Bulk Package Label



MAXIMUM STRENGTH

Pansolix® Pain Relieving Patch

4% Lidocaine

ODORFREE

NUMBS SENSITIVE NERVES FOR TEMPORARY RELIEF OF PAIN

  • BACK NECK
  • KNEES
  • ELBOWS
  • SHOULDERS

30 PATCHES 3-15/16" x 5-1/2" (10 cm x 14 cm)

Inactive Ingredients

dihydroxyaluminum aminoacetate, edetate disodium, glycerin, kaolin, methylparaben, polyacrylic acid, polysorbate 80, polyvinylpyrrolidone K90, propylene glycol, propylparaben, sodium polyacrylate, tartaric acid, titanium dioxide, water.

Questions and Comments

Call 1-855-314-1850

When Using This Product
  • use only as directed rashes
  • 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 or blistering
  • conditions 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 and Pets

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


Structured Label Content

Uses

for temporary relief of pain

Purpose

Topical Anesthetic

Warnings

For external use only

Directions

Adults and children 12 years of age and over:

  • clean and dry affected area
  • remove backing layer from patch and apply to the affected area (see pictorial representation)
  • remove patch from the skin after at most 8-hour application
  • apply to affected area not more than 3 to 4 times daily

children under 12 years of age: consult a doctor

Do Not Use
  • more than one 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 (Other information)
  • store at 20-25°C (68-77°F)
  • protect product from direct sunlight and excessive moisture

Bulk Package Label



MAXIMUM STRENGTH

Pansolix® Pain Relieving Patch

4% Lidocaine

ODORFREE

NUMBS SENSITIVE NERVES FOR TEMPORARY RELIEF OF PAIN

  • BACK NECK
  • KNEES
  • ELBOWS
  • SHOULDERS

30 PATCHES 3-15/16" x 5-1/2" (10 cm x 14 cm)

Inactive Ingredients

dihydroxyaluminum aminoacetate, edetate disodium, glycerin, kaolin, methylparaben, polyacrylic acid, polysorbate 80, polyvinylpyrrolidone K90, propylene glycol, propylparaben, sodium polyacrylate, tartaric acid, titanium dioxide, water.

Questions and Comments

Call 1-855-314-1850

When Using This Product
  • use only as directed rashes
  • 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 or blistering
  • conditions 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 and Pets

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


Advanced Ingredient Data


Raw Label Data

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