SPL v1
SPL
SPL Set ID 40c5fa5a-e6fe-02d1-e063-6294a90aac92
Route
TOPICAL
Published
Effective Date 2025-10-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-10-01

Description

Lidocaine 4 % +Menthol 1% w/w


Medication Information

Warnings and Precautions

For external use only.

Indications and Usage

For the temporary relief of minor pain

Dosage and Administration

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

Description

Lidocaine 4 % +Menthol 1% w/w

Section 44425-7

Store between 15-30℃(59-86℉)

keep away from childre

Section 50565-1

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

Section 50567-7

Use only as directed

Do not bandage tightly

Avoid contact with eyes, mucous membranes or rashes

If contact occurs, rinse thoroughly with water

Section 50568-5

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

Section 50570-1

hildren under 12 years of age: Do not use, consult a physician.

Section 51727-6

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

Section 51945-4

Section 53414-9

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

Section 55105-1

Lidocaine: Topical anesthetic / Menthol: Topical analgesic

Section 55106-9

Lidocaine 4 % +Menthol 1% w/w


Structured Label Content

Indications and Usage (34067-9)

For the temporary relief of minor pain

Dosage and Administration (34068-7)

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

Warnings and Precautions (34071-1)

For external use only.

Section 44425-7 (44425-7)

Store between 15-30℃(59-86℉)

keep away from childre

Section 50565-1 (50565-1)

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

Section 50567-7 (50567-7)

Use only as directed

Do not bandage tightly

Avoid contact with eyes, mucous membranes or rashes

If contact occurs, rinse thoroughly with water

Section 50568-5 (50568-5)

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

Section 50570-1 (50570-1)

hildren under 12 years of age: Do not use, consult a physician.

Section 51727-6 (51727-6)

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

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Lidocaine: Topical anesthetic / Menthol: Topical analgesic

Section 55106-9 (55106-9)

Lidocaine 4 % +Menthol 1% w/w


Advanced Ingredient Data


Raw Label Data

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