SPL v3
SPL
SPL Set ID 31d5e5c9-6ec4-4496-8a4c-cca39a2cbe32
Route
TOPICAL
Published
Effective Date 2024-12-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (4 g)
Inactive Ingredients
Dihydroxyaluminum Aminoacetate Edetate Disodium Glycerin Isopropyl Myristate Polyacrylic Acid (250000 Mw) Propylparaben Propylene Glycol Sodium Polyacrylate (2500000 Mw) Tartaric Acid Titanium Dioxide Polysorbate 80 Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-11-29

Description

Lidocaine 4%

Purpose

Topical Anesthetic


Medication Information

Purpose

Topical Anesthetic

Description

Lidocaine 4%

Uses

Temporarily relieves mild to moderate aches and pains of muscles and joints associated with muscle soreness, strains, sprains, arthritis, simple backache, muscle stiffness, bruises

Section 42229-5

INSTRUCTIONS FOR USE

  • Determine area of patch application. If the pain area is smaller than the patch, patches may be cut into smaller sizes with scissors 
  • Safely discard the remaining unused pieces of cut patches where children and pets cannot reach 
  • Remove the transparent protective film (clear plastic barrier) before application of patches to the skin 
  • Apply immediately after removing the protective film Apply 1 patch to the affected area so that the patch covers all or most of the painful area
  • Remove patch if irritation occurs

Children under 12 years of age: Consult a doctor.

Section 50565-1

Keep out of reach of children.If product is put in mouth, get medical help of contact a Poison Control Center right away. Package is not child resistant. Dispose of the used patches by folding sticky ends together.

Warnings

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, any patch from a pouch that has been opened for 7 or more days.

Ask a doctor before use if you are allergic to topical products, you are taking a diuretic, you have high blood pressure, heart disease, kidney disease, or you are pregnant.

When using this product wash hands after applying or removing patch. Avoid contact with eyes. If eye contact occurs, rinse thoroughly with water.

Stop use and consult your physician if rash, irritation, or itching develops, or condition worsens.

If pregnant or breastfeeding, ask a doctor before use while breastfeeding and during the first 6 months of pregnancy. Do not use during the last 3 months of pregnancy because it may cause problems in the unborn child or complications during delivery.

For external use only

Directions

Adults and children 12 years and over: apply 1 to 2 patches to the affected area of intact skin. Lidocaine patch should be removed after 12 hours of continuous use and remain off for at least 12 hours.

Product Label

Active Ingredient

Lidocaine 4%

Other Information

Some individuals may not experience pain relief until several minutes or hours after applying the patch. Store in a cool, dry place. Protect the product from excessive moisture or sunlight. Store at 67-77°F (19-25°C).

Inactive Ingredients

dihydroxyaluminum aminoacetate, edetate disodium, glycerin, isopropyl myristate, polyacrylic acid, propyl p-hydroxybenzoate, propylene glycol, sodium polyacrylate, tartaric acid, titanium dioxide, tween 80, water


Structured Label Content

Uses

Temporarily relieves mild to moderate aches and pains of muscles and joints associated with muscle soreness, strains, sprains, arthritis, simple backache, muscle stiffness, bruises

Section 42229-5 (42229-5)

INSTRUCTIONS FOR USE

  • Determine area of patch application. If the pain area is smaller than the patch, patches may be cut into smaller sizes with scissors 
  • Safely discard the remaining unused pieces of cut patches where children and pets cannot reach 
  • Remove the transparent protective film (clear plastic barrier) before application of patches to the skin 
  • Apply immediately after removing the protective film Apply 1 patch to the affected area so that the patch covers all or most of the painful area
  • Remove patch if irritation occurs

Children under 12 years of age: Consult a doctor.

Section 50565-1 (50565-1)

Keep out of reach of children.If product is put in mouth, get medical help of contact a Poison Control Center right away. Package is not child resistant. Dispose of the used patches by folding sticky ends together.

Purpose

Topical Anesthetic

Warnings

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, any patch from a pouch that has been opened for 7 or more days.

Ask a doctor before use if you are allergic to topical products, you are taking a diuretic, you have high blood pressure, heart disease, kidney disease, or you are pregnant.

When using this product wash hands after applying or removing patch. Avoid contact with eyes. If eye contact occurs, rinse thoroughly with water.

Stop use and consult your physician if rash, irritation, or itching develops, or condition worsens.

If pregnant or breastfeeding, ask a doctor before use while breastfeeding and during the first 6 months of pregnancy. Do not use during the last 3 months of pregnancy because it may cause problems in the unborn child or complications during delivery.

For external use only

Directions

Adults and children 12 years and over: apply 1 to 2 patches to the affected area of intact skin. Lidocaine patch should be removed after 12 hours of continuous use and remain off for at least 12 hours.

Product Label (Product label)

Active Ingredient

Lidocaine 4%

Other Information (Other information)

Some individuals may not experience pain relief until several minutes or hours after applying the patch. Store in a cool, dry place. Protect the product from excessive moisture or sunlight. Store at 67-77°F (19-25°C).

Inactive Ingredients (Inactive ingredients)

dihydroxyaluminum aminoacetate, edetate disodium, glycerin, isopropyl myristate, polyacrylic acid, propyl p-hydroxybenzoate, propylene glycol, sodium polyacrylate, tartaric acid, titanium dioxide, tween 80, water


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)