SPL v4
SPL
SPL Set ID 434cb8b2-a996-5360-e063-6394a90ada03
Route
TOPICAL
Published
Effective Date 2025-11-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

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

Description

Lidocaine 4 % +Menthol 1% w/w.

Purpose

Topical anesthetic

Storage and Handling

Store between 15-30℃(59-86℉)


Medication Information

Purpose

Topical anesthetic

Storage and Handling

Store between 15-30℃(59-86℉)

Description

Lidocaine 4 % +Menthol 1% w/w.

Use

For temporary relief of 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 sticky side to desired area

Apply patch to affected area not more than 3 times daily

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

Can be cut for custom sizing of pain area

Children under 12 years of age:

Do not use, consult a doctor

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

More than one week without consulting a doctor.

Active Ingredient(s)

Lidocaine 4 % +Menthol 1% w/w.

Inactive Ingredients

Acrylamide/Sodium acryloyldimethyltaurate copolymer, Dihydroxyaluminum aminoacetate,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 apply to wounds or damaged, broken, or irritated skin

Avoid contact with eyes, mucous membranes or rashes.If contact occurs, rinse thoroughly

Do not bandage tightly

Do not use at the same time as other topical analgesics.

If Pregnant Or Breastfeeding

If pregnant or breastfeeding, ask a physicianbefore 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 and blistering as rare but serious burns can occur

Condition worsens

Symptoms persist for more than 7 days

Symptoms clear up and occur again within a few days


Structured Label Content

Use (USE)

For temporary relief of pain.

Image (IMAGE)

Purpose

Topical anesthetic

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 sticky side to desired area

Apply patch to affected area not more than 3 times daily

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

Can be cut for custom sizing of pain area

Children under 12 years of age:

Do not use, consult a doctor

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

More than one week without consulting a doctor.

Active Ingredient(s)

Lidocaine 4 % +Menthol 1% w/w.

Inactive Ingredients (Inactive ingredients)

Acrylamide/Sodium acryloyldimethyltaurate copolymer, Dihydroxyaluminum aminoacetate,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℉)

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 eyes, mucous membranes or rashes.If contact occurs, rinse thoroughly

Do not bandage tightly

Do not use at the same time as other topical analgesics.

If Pregnant Or Breastfeeding (If pregnant or breastfeeding)

If pregnant or breastfeeding, ask a physicianbefore 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 and blistering as rare but serious burns can occur

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

All Sections (JSON)