83781-014

83781-014
SPL v1
SPL
SPL Set ID 49703717-69a6-e480-e063-6394a90ac69c
Route
TOPICAL
Published
Effective Date 2026-01-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (3 g) Lidocaine (4 g)
Inactive Ingredients
Propylene Glycol Edetate Disodium Polyacrylic Acid (250000 Mw) Dihydroxyaluminum Aminoacetate Kaolin Methylparaben Glycerin Polysorbate 80 Propylparaben Water Sodium Polyacrylate (2500000 Mw) Povidone K90 Titanium Dioxide Tartaric Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2026-01-28

Description

Lidocaine 4% Menthol 3%

Purpose

Topical Analgesic


Medication Information

Purpose

Topical Analgesic

Description

Lidocaine 4% Menthol 3%

Use

For temporary relief of pain

Stop Use

localized skin reactions occur, such as rash, itching, redness, irritation, pain swelling and blistering conditions worsen



█ symptoms persist for more than 7 days



█ symptoms clear up and occur again within a few days

Warnings

For external use only

Questions
Ask Doctor

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



█ Children under 12 years of age: consult a doctor

Directions

Adults and Children above 12 years old

1.Clean and dry the skin.

2.Prepare the adhesive secure patch and peel off its backing.

3.Peel off the pain patch's protective film.

4.Apply to the target area.

5.Press to secure in place.Remove patch from the skin after at most 8 hours of application.

Children under 12 years of age: consult a doctor.

Do Not Use

█ more than 1 patch at a time

█ on wounds or damaged skin

█ with a heating pad

█ if you have ever had an allergic reaction to this product or any of its ingredients

When Using

█ use only as directed

█ avoid contact with the eyes, mucous membranes or rashes

█ do not bandage tightly

Active Ingredient

Lidocaine 4%

Menthol 3%

Other Information

█ avoid storing product in direct sunlight



█ protect product from excessive moisture



█ store at 20-25°C(68-77°F)

Inactive Ingredients

Aluminum Glycinate, Edetate Disodium, Ethylhexylglycerin, Glycerin, Kaolin, Phenoxyethanol, Polyvinylpyrrolidone, Propylene Glycol, Sodium Carboxymethylcellulose, Sodium Polyacrylate, Tartaric Acid, Water

Principal Display Panel

Keep Out of Reach of Children

Keep Out Of Reach Of Children

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


Structured Label Content

Use

For temporary relief of pain

Purpose

Topical Analgesic

Stop Use

localized skin reactions occur, such as rash, itching, redness, irritation, pain swelling and blistering conditions worsen



█ symptoms persist for more than 7 days



█ symptoms clear up and occur again within a few days

Warnings

For external use only

Questions
Ask Doctor

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



█ Children under 12 years of age: consult a doctor

Directions

Adults and Children above 12 years old

1.Clean and dry the skin.

2.Prepare the adhesive secure patch and peel off its backing.

3.Peel off the pain patch's protective film.

4.Apply to the target area.

5.Press to secure in place.Remove patch from the skin after at most 8 hours of application.

Children under 12 years of age: consult a doctor.

Do Not Use (Do not use)

█ more than 1 patch at a time

█ on wounds or damaged skin

█ with a heating pad

█ if you have ever had an allergic reaction to this product or any of its ingredients

When Using

█ use only as directed

█ avoid contact with the eyes, mucous membranes or rashes

█ do not bandage tightly

Active Ingredient

Lidocaine 4%

Menthol 3%

Other Information (Other information)

█ avoid storing product in direct sunlight



█ protect product from excessive moisture



█ store at 20-25°C(68-77°F)

Inactive Ingredients (Inactive ingredients)

Aluminum Glycinate, Edetate Disodium, Ethylhexylglycerin, Glycerin, Kaolin, Phenoxyethanol, Polyvinylpyrrolidone, Propylene Glycol, Sodium Carboxymethylcellulose, Sodium Polyacrylate, Tartaric Acid, Water

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

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

Keep Out Of Reach Of Children

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


Advanced Ingredient Data


Raw Label Data

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