SPL v1
SPL
SPL Set ID eccfbb3c-3f42-4e20-824e-233cd83a7673
Route
TOPICAL
Published
Effective Date 2025-07-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (1 g) Lidocaine (4 g)
Inactive Ingredients
Polyacrylic Acid (300000 Mw) Polyacrylic Acid (800000 Mw) Dihydroxyaluminum Aminoacetate Glycerin Water Dmdm Hydantoin Edetate Disodium Anhydrous Sodium Polyacrylate (8000 Mw) Acrylamide/sodium Acryloyldimethyltaurate Copolymer (120000 Mpa.s At 1%) Tartaric Acid Titanium Dioxide Laurocapram Propylene Glycol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-07-10

Description

Lidocaine 4%  Menthol 1% 

Purpose

Topical anesthetic Topical analgesic

Storage and Handling

Store between 15-30℃(59-86℉) 


Medication Information

Purpose

Topical anesthetic

Topical analgesic

Storage and Handling

Store between 15-30℃(59-86℉) 

Description

Lidocaine 4%  Menthol 1% 

Use

For temporary relief of pain.

Warnings

For external use only.

Directions

Adults and children 12 years of age and older:Clean and dry affected area · Remove flm from patch and apply sticky side to desired area · Apply patch toaffected area not more than 3 times daily. Do not leave on skin for more than a total of8 hours per day. Canbe cut for custom sizing of pain area . Children under 12 years of age: Consult a doctor . Supervise childrenwhen they use this product.

Do Not Use

More than 1 patch at a time . On wounds or damaged skin . With a heating pad such as electric heating pad, as thismay result in excessive skin irritation or skin burn · lfyou are allergic to anyingredients of this product . ln largequantities, particularly over raw surfaces or blistered areas . More than one week without consulting a doctor.

Active Ingredient(s)

Lidocaine 4% 

Menthol 1% 

Inactive Ingredients

Acrylamide/Sodium acryloyldimethyltaurate copolymer, Dihydroxyaluminum aminoacetate, DMDMhydantoin, Edetic acid, Glycerin, Laurocapram, Polyacrylic acid, Propylene glycol, Sodium polyacrylateTartaric acid,Titanium dioxide. Water.

When Using This Product:

Use only as directed . Do not apply to wounds or damaged, broken, or irritated skin · Avoid contact with eyesmucous membranes or rashes. lf contact occurs, rinse thoroughly · Do not bandage tightly. Do not use at thesame time as other topical analgesics.

Keep Out of Reach of Children

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

Stop Use and Ask A Doctor If:

. Localized skin reactions occur, such as rash, itching, redness, irritation, pain and blistering as rare butserious burns can occur . Condition worsens · Symptoms persist for more than 7 days · Symptoms clear upand occur again within a few days.

If pregnant or breast feeding, ask a physician before use.

Package Label Principal Display Panel


Structured Label Content

Use

For temporary relief of pain.

Purpose

Topical anesthetic

Topical analgesic

Warnings

For external use only.

Directions

Adults and children 12 years of age and older:Clean and dry affected area · Remove flm from patch and apply sticky side to desired area · Apply patch toaffected area not more than 3 times daily. Do not leave on skin for more than a total of8 hours per day. Canbe cut for custom sizing of pain area . Children under 12 years of age: Consult a doctor . Supervise childrenwhen they use this product.

Do Not Use (Do not use)

More than 1 patch at a time . On wounds or damaged skin . With a heating pad such as electric heating pad, as thismay result in excessive skin irritation or skin burn · lfyou are allergic to anyingredients of this product . ln largequantities, particularly over raw surfaces or blistered areas . More than one week without consulting a doctor.

Active Ingredient(s)

Lidocaine 4% 

Menthol 1% 

Inactive Ingredients (Inactive ingredients)

Acrylamide/Sodium acryloyldimethyltaurate copolymer, Dihydroxyaluminum aminoacetate, DMDMhydantoin, Edetic acid, Glycerin, Laurocapram, Polyacrylic acid, Propylene glycol, Sodium polyacrylateTartaric acid,Titanium dioxide. Water.

Storage and Handling (STORAGE AND HANDLING)

Store between 15-30℃(59-86℉) 

When Using This Product: (When using this product:)

Use only as directed . Do not apply to wounds or damaged, broken, or irritated skin · Avoid contact with eyesmucous membranes or rashes. lf contact occurs, rinse thoroughly · Do not bandage tightly. Do not use at thesame time as other topical analgesics.

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.

Stop Use and Ask A Doctor If: (Stop use and ask a doctor if:)

. Localized skin reactions occur, such as rash, itching, redness, irritation, pain and blistering as rare butserious burns can occur . Condition worsens · Symptoms persist for more than 7 days · Symptoms clear upand occur again within a few days.

If pregnant or breast feeding, ask a physician before use.

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


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Raw Label Data

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