84291-005

84291-005
SPL v1
SPL
SPL Set ID 45944b40-d43b-a354-e063-6394a90ad3c5
Route
TOPICAL
Published
Effective Date 2025-12-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (4 U)
Inactive Ingredients
Water Glycerin Propylene Glycol Sodium Polyacrylate (2500000 Mw) Polyvinyl Alcohol Tartaric Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-12-11

Description

Lidocaine 4.0%

Purpose

Topical anesthetic


Medication Information

Purpose

Topical anesthetic

Description

Lidocaine 4.0%

Use

Temporarily relieves muscle soreness and minor joint pain

Section 50565-1

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

Section 50566-9

Your condition worsens

Localized skin reactions such as rash,itching, redness, swelling,or blistering occur

Symptoms persist for more than 7 days or clear up and then return within a few days

Section 50567-7

Use only as directed

Do not bandage tightly

Do not microwave

Avoid contact with eyes, mucous membranes, or rashes

Warnings

For external use only

Directions

Adults and children 12 years of age and older:

■ Clean and dry the affected area

■ Do not use more than 3 to 4 patches daily

■ Carefully peel off the protective film, starting from one corner

■ Apply the sticky side of the patch to the affected area and press firmly to ensure adhesion

■ Use only one patch at a time

■ Leave on for up to 8 to 12 hours

■ Discard the patch after a single use

Children under 12 years of age:Consult a physician

Do Not Use

■On cut, irritated, or swollen skin ■ With a heating pad or device

■If you are allergic to any active or inactive ingredients in this product

■For more than one week without consulting a doctor ■More than one patch at a time

■If the pouch is damaged or opened

Other Information

Store in a clean, dry place away from direct sunlight.

Do not store at temperatures above 30°C (86°F).

Protect from excessive moisture..

Active Ingredient(s)

Lidocaine 4.0%

Inactive Ingredients

Water, Glycerin, Propylene Glycol, Sodium Polyacrylate, Polyvinyl Alcohol, Tartaric Acid

Package Label Principal Display Panel


Structured Label Content

Use

Temporarily relieves muscle soreness and minor joint pain

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

Your condition worsens

Localized skin reactions such as rash,itching, redness, swelling,or blistering occur

Symptoms persist for more than 7 days or clear up and then return within a few days

Section 50567-7 (50567-7)

Use only as directed

Do not bandage tightly

Do not microwave

Avoid contact with eyes, mucous membranes, or rashes

Purpose

Topical anesthetic

Warnings

For external use only

Directions

Adults and children 12 years of age and older:

■ Clean and dry the affected area

■ Do not use more than 3 to 4 patches daily

■ Carefully peel off the protective film, starting from one corner

■ Apply the sticky side of the patch to the affected area and press firmly to ensure adhesion

■ Use only one patch at a time

■ Leave on for up to 8 to 12 hours

■ Discard the patch after a single use

Children under 12 years of age:Consult a physician

Do Not Use (Do not use)

■On cut, irritated, or swollen skin ■ With a heating pad or device

■If you are allergic to any active or inactive ingredients in this product

■For more than one week without consulting a doctor ■More than one patch at a time

■If the pouch is damaged or opened

Other Information (Other information)

Store in a clean, dry place away from direct sunlight.

Do not store at temperatures above 30°C (86°F).

Protect from excessive moisture..

Active Ingredient(s)

Lidocaine 4.0%

Inactive Ingredients (Inactive ingredients)

Water, Glycerin, Propylene Glycol, Sodium Polyacrylate, Polyvinyl Alcohol, Tartaric Acid

Package Label Principal Display Panel (Package Label - Principal Display Panel)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)