Lidopro Patch

Lidopro Patch
SPL v1
SPL
SPL Set ID 30c97646-db06-df84-e063-6394a90a7743
Route
TRANSDERMAL
Published
Effective Date 2025-03-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (84 mg) Lidocaine (336 mg)
Inactive Ingredients
Glycerin Polysorbate 80 Methylparaben Sodium Polyacrylate (8000 Mw) Tartaric Acid Water Dihydroxyaluminum Aminoacetate Polyacrylic Acid (8000 Mw) Propylparaben Sodium Polyacrylate (2500000 Mw) Kaolin Edetate Sodium Titanium Dioxide Propanediol Carboxymethylcellulose Sodium

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-03-20

Description

Lidocaine 4% Menthol 1%

Purpose

External Anesthetic External Analgesic


Medication Information

Purpose

External Anesthetic

External Analgesic

Description

Lidocaine 4% Menthol 1%

Uses

For the temporary relief of pain.

Warnings

For external use only.

Directions

Adults 18 years and older:

  • clean and dry affected area
  • open pouch and remove one patch
  • remove protective film from patch
  • apply one patch to the affected area of pain and leave in place for 8 to 12 hours
Do Not Use
  • on the face or rashes, on wounds or damaged skin
  • in the eyes, mouth, or other mucous membranes
  • on genitals
  • with a heating pad
  • right before or after heart surgery
  • any patch from a pouch that has been opened for 7 or more days
  • in large quantities, particularly over raw surfaces or blistered areas
  • if tamper-evident seal is torn, broken, or missing
  • more than 2 patches per day unless directed by a doctor
  • children under 18 years of age
Questions?

Call toll-free (800) 224-2048

Active Ingredient

Lidocaine 4%

Menthol 1%

Other Information
  • Some individuals may not experience pain relief until several minutes or hours after applying the patch
  • avoid storing product in direct sunlight
  • protect product from excessive moisture
  • store at 67-77ºF (19-25ºC)
Inactive Ingredients

Carboxymethylcellose sodium, Dihydroxyaluminum aminoacetate, Edetate sodium, Glycerin, Kaolin, Methyl parahydroxybenzoate, Partially neutralized Sodium polyacrylate, Polyacrylic acid, Polysorbate 80, Propyl parahydroxybenzoate, Propylene glycol, Sodium Polyacrylate, Tartaric acid, Titanium dioxide, water

When Using This Product
  • Avoid contact with eyes. If eye contact occurs, rinse thoroughly with water.
  • The risk of heart attack or stroke may increase if you use more than directed or for longer than directed.
Stop Use and Ask Doctor If

condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

Keep Out of Reach of Children.

If put in mouth, seek medical help or contact a Poison Control Center right away. Dispose if the used patches by folding sticky ends together.

Ask A Doctor Before Use If You Have
  • allergies to topical products
  • high blood pressure, heart disease, or kidney disease
Package Label Principal Display Panel

If Pregnant of Breast Feeding, Ask A Health Professional Before Use

Do not use during last 3 months of pregnancy because it may cause problems in the unborn child or complications during delivery.


Structured Label Content

Uses

For the temporary relief of pain.

Purpose

External Anesthetic

External Analgesic

Warnings

For external use only.

Directions

Adults 18 years and older:

  • clean and dry affected area
  • open pouch and remove one patch
  • remove protective film from patch
  • apply one patch to the affected area of pain and leave in place for 8 to 12 hours
Do Not Use (Do not use)
  • on the face or rashes, on wounds or damaged skin
  • in the eyes, mouth, or other mucous membranes
  • on genitals
  • with a heating pad
  • right before or after heart surgery
  • any patch from a pouch that has been opened for 7 or more days
  • in large quantities, particularly over raw surfaces or blistered areas
  • if tamper-evident seal is torn, broken, or missing
  • more than 2 patches per day unless directed by a doctor
  • children under 18 years of age
Questions?

Call toll-free (800) 224-2048

Active Ingredient (Active ingredient)

Lidocaine 4%

Menthol 1%

Other Information (Other information)
  • Some individuals may not experience pain relief until several minutes or hours after applying the patch
  • avoid storing product in direct sunlight
  • protect product from excessive moisture
  • store at 67-77ºF (19-25ºC)
Inactive Ingredients (Inactive ingredients)

Carboxymethylcellose sodium, Dihydroxyaluminum aminoacetate, Edetate sodium, Glycerin, Kaolin, Methyl parahydroxybenzoate, Partially neutralized Sodium polyacrylate, Polyacrylic acid, Polysorbate 80, Propyl parahydroxybenzoate, Propylene glycol, Sodium Polyacrylate, Tartaric acid, Titanium dioxide, water

When Using This Product (When using this product)
  • Avoid contact with eyes. If eye contact occurs, rinse thoroughly with water.
  • The risk of heart attack or stroke may increase if you use more than directed or for longer than directed.
Stop Use and Ask Doctor If (Stop use and ask doctor if)

condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

Keep Out of Reach of Children. (Keep out of reach of children.)

If put in mouth, seek medical help or contact a Poison Control Center right away. Dispose if the used patches by folding sticky ends together.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • allergies to topical products
  • high blood pressure, heart disease, or kidney disease
Package Label Principal Display Panel (PACKAGE LABEL PRINCIPAL DISPLAY PANEL)

If Pregnant of Breast Feeding, Ask A Health Professional Before Use (If pregnant of breast-feeding, ask a health professional before use)

Do not use during last 3 months of pregnancy because it may cause problems in the unborn child or complications during delivery.


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Raw Label Data

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