83781-015

83781-015
SPL v1
SPL
SPL Set ID 49706db7-bacd-190f-e063-6394a90a3a8e
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
Dihydroxyaluminum Aminoacetate Glycerin Polyacrylic Acid (250000 Mw) Povidone K90 Propylene Glycol Sodium Polyacrylate (2500000 Mw) Methylparaben Titanium Dioxide Polysorbate 80 Tartaric Acid Water Kaolin Edetate Disodium Propylparaben

Identifiers & Packaging

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

Description

Lidocaine 4% Menthol 3%

Purpose

Topical Analgesic wrist, knees, back, neck, hips, shoulders, elbows.


Medication Information

Purpose

Topical Analgesic

wrist, knees, back, neck, hips, shoulders, elbows.

Description

Lidocaine 4% Menthol 3%

Use

For temporary relief of pain

Stop Use

1.If you experience any signs of worsening or skin damage, such as redness, irritation, swelling, or blistering.

2.If symptoms persist for more than 7 days, or if symptoms clear up and then reappear within a few days.

3.If you are pregnant or breastfeeding, consult a healthcare professional before use.

4.Chidren under 12 years of age:consult a doctor.

Warnings

For external use only

Questions
Ask Doctor

1.If you experience any signs of worsening or skin damage, such as redness, irritation, swelling, or blistering.

2.If symptoms persist for more than 7 days, or if symptoms clear up and then reappear within a few days.

3.If you are pregnant or breastfeeding, consult a healthcare professional before use.

4.Chidren 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.

Children under age of 12: Consult a doctor.

Do Not Use

1.Not for use by pregnant or nursing women, infants, or anyone allergic to any ingredient.

2.Do not use on wounds or damaged skin.

3.Do not use with other patch, ointments, creams, sprays, or liniments.

4.Do not tightly wrap the application area or use local heat sources (such as heating pads) on it.

5.Do not use more than 1 patch at a time.

6.Avoid contact with the eyes.

7.Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

When Using

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

Store in a clean, dry place outside of direct sunlight. Protect product from excessive moisture.

Inactive Ingredients

Aluminum Glycinate, Disodium EDTA, Ethylhexylglycerin, Glycerin, Kaolin, Phenoxyethanol, Polyvinylpyrrolidone, Propylene Glycol, Sodium Carboxymethyl Cellulose, 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

wrist, knees, back, neck, hips, shoulders, elbows.

Stop Use

1.If you experience any signs of worsening or skin damage, such as redness, irritation, swelling, or blistering.

2.If symptoms persist for more than 7 days, or if symptoms clear up and then reappear within a few days.

3.If you are pregnant or breastfeeding, consult a healthcare professional before use.

4.Chidren under 12 years of age:consult a doctor.

Warnings

For external use only

Questions
Ask Doctor

1.If you experience any signs of worsening or skin damage, such as redness, irritation, swelling, or blistering.

2.If symptoms persist for more than 7 days, or if symptoms clear up and then reappear within a few days.

3.If you are pregnant or breastfeeding, consult a healthcare professional before use.

4.Chidren 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.

Children under age of 12: Consult a doctor.

Do Not Use (Do not use)

1.Not for use by pregnant or nursing women, infants, or anyone allergic to any ingredient.

2.Do not use on wounds or damaged skin.

3.Do not use with other patch, ointments, creams, sprays, or liniments.

4.Do not tightly wrap the application area or use local heat sources (such as heating pads) on it.

5.Do not use more than 1 patch at a time.

6.Avoid contact with the eyes.

7.Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

When Using

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)

Store in a clean, dry place outside of direct sunlight. Protect product from excessive moisture.

Inactive Ingredients (Inactive ingredients)

Aluminum Glycinate, Disodium EDTA, Ethylhexylglycerin, Glycerin, Kaolin, Phenoxyethanol, Polyvinylpyrrolidone, Propylene Glycol, Sodium Carboxymethyl Cellulose, 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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