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

Purpose

Topical anesthetic

Description

Lidocaine 4.0%


Medication Information

Warnings

For external use only

Purpose

Topical anesthetic

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

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..

Inactive Ingredients

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

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

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

Active Ingredient(s)

Lidocaine 4.0%

Package Label Principal Display Panel


Structured Label Content

Warnings

For external use only

Purpose

Topical anesthetic

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

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..

Inactive Ingredients (Inactive ingredients)

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

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

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

Active Ingredient(s)

Lidocaine 4.0%

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


Advanced Ingredient Data


Raw Label Data

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