SPL v2
SPL
SPL Set ID 43616ad7-58bb-e5ad-e063-6394a90a192b
Route
TOPICAL
Published
Effective Date 2025-11-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-11-11

Description

Lidocaine 4 % +Menthol 1% w/w.

Purpose

Lidocaine: Topical anesthetic / Menthol: Topical analgesic

Storage and Handling

Store between 15-30℃(59-86℉) keep away from children


Medication Information

Purpose

Lidocaine: Topical anesthetic / Menthol: Topical analgesic

Storage and Handling

Store between 15-30℃(59-86℉) keep away from children

Description

Lidocaine 4 % +Menthol 1% w/w.

Use

For the temporary relief of minor pain.

Image

Warnings

For external use only.

Directions

Adults and children 12 years of age and older:

Clean and dry affected area

Remove film from patch and apply to the skin

Apply 1 patch at a time to the affected area, not more than 3 times daily.

Remove patch from the skin.

Do not leave on skin for more than a total of 8 hours per day

Children under 12 years of age:

Do not use, consult a physician.

Supervise children when 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 this may result in excessive skin irritation or skin burn

If you are allergic to any ingredients of this product

In large quantities, particularly over raw surfaces or blistered areas

Active Ingredient(s)

Lidocaine 4 % +Menthol 1% w/w.

Inactive Ingredients

Acryloyldime/ Sodium Acryloyldimethyltaurate copolymer, Dihydroxyaluminum aminoacetetel, DMDM hydantoin, Edetic acid,, Glycerin, Laurocapram,Polyacrylic acid, Propylene glycol, Sodium polyacrylate, Tartaric acid, Titanium dioxide, Water

When Using This Product:

Use only as directed

Do not bandage tightly

Avoid contact with eyes, mucous membranes or rashes

If contact occurs, rinse thoroughly with water

If Pregnant Or Breastfeeding

If pregnant or breastfeeding, ask a health professional before use.

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:

Localized skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blistering

Condition worsens

Symptoms persist for more than 7 days

Symptoms clear up and occur again within a few days


Structured Label Content

Use

For the temporary relief of minor pain.

Image (IMAGE)

Purpose

Lidocaine: Topical anesthetic / Menthol: Topical analgesic

Warnings

For external use only.

Directions

Adults and children 12 years of age and older:

Clean and dry affected area

Remove film from patch and apply to the skin

Apply 1 patch at a time to the affected area, not more than 3 times daily.

Remove patch from the skin.

Do not leave on skin for more than a total of 8 hours per day

Children under 12 years of age:

Do not use, consult a physician.

Supervise children when 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 this may result in excessive skin irritation or skin burn

If you are allergic to any ingredients of this product

In large quantities, particularly over raw surfaces or blistered areas

Active Ingredient(s)

Lidocaine 4 % +Menthol 1% w/w.

Inactive Ingredients (Inactive ingredients)

Acryloyldime/ Sodium Acryloyldimethyltaurate copolymer, Dihydroxyaluminum aminoacetetel, DMDM hydantoin, Edetic acid,, Glycerin, Laurocapram,Polyacrylic acid, Propylene glycol, Sodium polyacrylate, Tartaric acid, Titanium dioxide, Water

Storage and Handling (STORAGE AND HANDLING)

Store between 15-30℃(59-86℉) keep away from children

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

Use only as directed

Do not bandage tightly

Avoid contact with eyes, mucous membranes or rashes

If contact occurs, rinse thoroughly with water

If Pregnant Or Breastfeeding (If pregnant or breastfeeding)

If pregnant or breastfeeding, ask a health professional before use.

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.

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, swelling and blistering

Condition worsens

Symptoms persist for more than 7 days

Symptoms clear up and occur again within a few days


Advanced Ingredient Data


Raw Label Data

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