Lidoreal Patch

Lidoreal Patch
SPL v2
SPL
SPL Set ID 19f1c037-b4b8-47b0-b0f9-036691c1d307
Route
TOPICAL
Published
Effective Date 2024-07-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (4 mg) Menthol (1 mg)
Inactive Ingredients
Dihydroxyaluminum Aminoacetate Anhydrous Edetate Disodium Glycerin Hydroxyacetophenone Kaolin Mineral Oil Polyacrylic Acid (250000 Mw) Polysorbate 80 Povidone K90 Propylene Glycol Sodium Polyacrylate (2500000 Mw) Tartaric Acid Titanium Dioxide Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-05-15

Description

Lidocaine 4%

Purpose

Topical Anesthetic


Medication Information

Purpose

Topical Anesthetic

Description

Lidocaine 4%

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
  • if pain lasts after using the first patch, a second patch may be applied for up to another 8 to 12 hours
  • only use one patch at a time
  • wash hands with soap and water after applying or removing patch
  • reseal pouch containing unused patches after each 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?

877-367-3250

Active Ingredient

Lidocaine 4%

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 67-77°F (19-25°C)
Inactive Ingredients

dihydroxyaluminum aminoacetate, edetate disodium, glycerin, hydroxyacetophenone, kaolin, mineral oil, polyacrylic acid, polusorbate 80, polyvinyl pyrrolidone, propylene glycol, sodium polyacrylate, tartaric acid, titanium dioxide, water

Principal Display Panel

NDC 81877-725-15

Forreal Pharmaceuticals

YOUR SOLUTION TO BETTER HEALTHCARE.

LIDOREAL

Lidocaine 4% and Menthol 1% Gel-Patch

15 PATCHES

10 cm x 14 cm each

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.
Keep Out of Reach of Children.

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

Stop Use and Consult A Doctor If

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

Ask A Doctor Before Use If You Have
  • allergies to topical products
  • high blood pressure, heart disease, or kidney disease.
If Pregnant Or 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

Topical Anesthetic

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
  • if pain lasts after using the first patch, a second patch may be applied for up to another 8 to 12 hours
  • only use one patch at a time
  • wash hands with soap and water after applying or removing patch
  • reseal pouch containing unused patches after each use
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?

877-367-3250

Active Ingredient

Lidocaine 4%

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 67-77°F (19-25°C)
Inactive Ingredients

dihydroxyaluminum aminoacetate, edetate disodium, glycerin, hydroxyacetophenone, kaolin, mineral oil, polyacrylic acid, polusorbate 80, polyvinyl pyrrolidone, propylene glycol, sodium polyacrylate, tartaric acid, titanium dioxide, water

Principal Display Panel

NDC 81877-725-15

Forreal Pharmaceuticals

YOUR SOLUTION TO BETTER HEALTHCARE.

LIDOREAL

Lidocaine 4% and Menthol 1% Gel-Patch

15 PATCHES

10 cm x 14 cm each

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.
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 of the used patches by folding sticky ends together.

Stop Use and Consult A Doctor If (Stop use and consult a doctor if)

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

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.
If Pregnant Or Breast Feeding, Ask A Health Professional Before Use. (If pregnant or 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.


Advanced Ingredient Data


Raw Label Data

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