83559-010

83559-010
SPL v1
SPL
SPL Set ID 3b82989d-7cc3-23d3-e063-6294a90ae2a3
Route
TOPICAL
Published
Effective Date 2025-08-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (4 g)
Inactive Ingredients
Polysorbate 80 Glycerin Aluminum Glycinate Ethylhexylglycerin Carboxymethylcellulose Sodium Edta Water Sodium Acrylate Titanium Dioxide Styrene/acrylamide Copolymer (mw 500000) Phenoxyethanol Sorbitol Tartaric Acid Povidone

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-08-04

Description

Lidocaine 4%

Purpose

Topical anesthetic


Medication Information

Purpose

Topical anesthetic

Description

Lidocaine 4%

Use

Temporarily relieves muscle soreness and minor joint pains in the wrist, knees, back, neck, hips, shoulders, elbows.

Stop Use

Stop use and ask a doctor if

skin reactions such as redness, swelling, blistering or other discomfort occur.

symptoms persist for more than 7 days

Warnings

For external use only

Ask Doctor

If pregnant or breast-feeding, ask a health professional before use.

Children under age of 12: Consult a doctor

Directions

Adults and Children above 12 years old:

Clean and dry the affected area.

Tear off the protective film and apply the exposed part of the patch to the the affected area.

Carefully remove remaining film while pressing the patch firmly on the skin.

Remove patch from the skin after at most 8-hour application.

Do Not Use

on wounds or damaged skin

with a heating pad or device

with other ointments, creams, sprays, or liniments

if you are allergic to any ingredients of this product

When Using

use only as directed

avoid contact with the eyes, mucous membranes or rashes

do not bandage tightly

Active Ingredient

Lidocaine 4%

Inactive Ingredients

Glycerin,Sodium polyacrylate,Polyvinyl pyrrolidone,Phenoxyethanol,Tartaric Acid,Ethyl ethyl glycerol,Sodium carboxymethyl cellulose,Aluminum Glycinate,Styrene acrylic copolymer emulsion,EDTA,Titanium Dioxide,Polysorbate 80,Sorbitol,Purified Water

Principal Display Panel

Keep Out of Reach of Children

If swallowed accidentally, get medical help or contact with Poison Control Center immediately.


Structured Label Content

Use

Temporarily relieves muscle soreness and minor joint pains in the wrist, knees, back, neck, hips, shoulders, elbows.

Purpose

Topical anesthetic

Stop Use

Stop use and ask a doctor if

skin reactions such as redness, swelling, blistering or other discomfort occur.

symptoms persist for more than 7 days

Warnings

For external use only

Ask Doctor

If pregnant or breast-feeding, ask a health professional before use.

Children under age of 12: Consult a doctor

Directions

Adults and Children above 12 years old:

Clean and dry the affected area.

Tear off the protective film and apply the exposed part of the patch to the the affected area.

Carefully remove remaining film while pressing the patch firmly on the skin.

Remove patch from the skin after at most 8-hour application.

Do Not Use (Do not use)

on wounds or damaged skin

with a heating pad or device

with other ointments, creams, sprays, or liniments

if you are allergic to any ingredients of this product

When Using

use only as directed

avoid contact with the eyes, mucous membranes or rashes

do not bandage tightly

Active Ingredient

Lidocaine 4%

Inactive Ingredients (Inactive ingredients)

Glycerin,Sodium polyacrylate,Polyvinyl pyrrolidone,Phenoxyethanol,Tartaric Acid,Ethyl ethyl glycerol,Sodium carboxymethyl cellulose,Aluminum Glycinate,Styrene acrylic copolymer emulsion,EDTA,Titanium Dioxide,Polysorbate 80,Sorbitol,Purified Water

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Keep Out of Reach of Children (Keep Out Of Reach Of Children)

If swallowed accidentally, get medical help or contact with Poison Control Center immediately.


Advanced Ingredient Data


Raw Label Data

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