83559-012 Active

83559-012 Active
SPL v3
SPL
SPL Set ID 44e27e7f-992f-d194-e063-6294a90a94e4
Route
TOPICAL
Published
Effective Date 2025-12-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (1 g) Lidocaine (4 g)
Inactive Ingredients
Ethylhexylglycerin Carboxymethylcellulose Sodium Water Edetate Disodium Kaolin Aluminum Glycinate Glycerin Povidone Phenoxyethanol Arnica Montana Flower Sodium Acrylate Tartaric Acid Propylene Glycol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-12-01

Description

Lidocaine 4% Menthol 1%

Purpose

Topical anesthetic Topical Analgesic


Medication Information

Purpose

Topical anesthetic

Topical Analgesic

Description

Lidocaine 4% Menthol 1%

Use

for the temporary relief of minor aches and pains of muscles and joints associated with *Simple backache

*Arthritis *Strains *Bruises *Sprains

Stop Use

localized skin reactions occur such as rash, itching, redness, irritation, pain, swelling or blistering

condition worsens

symptoms persist for more than 7 days or clear up and occur again within a few days

Warnings

For external use only

Questions

Questions or comments?

[email protected]

Ask Doctor

If pregnant or breast-feeding,ask a health professional before use.

Directions

Adults and children 12 years of age and over

apply 1 patch to clean, dry affected area

remove patch from backing and apply sticky side to affected area

wash hands thoroughly after applying

apply only 1 patch to affected area at a time

do not use more than 3 patches in 24 hours

remove patch after 8 hours; do not reuse

after use, fold patch so sticky sides adhere together and discard safely

Children under 12 years of age: ask a doctor

Do Not Use

more than one patch at a time

on wounds or damaged skin

with a heating pad or other heat source

with other ointments, creams, sprays, or liniments

for more than one week without consulting a doctor

if you have ever had an allergic reaction to this product or any of its ingredients

When Using

use only as directed

do not bandage tightly

avoid contact with eyes and mucous membranes

Active Ingredient

Lidocaine 4%

Menthol 1%

Other Information

store at 20°- 25°C(68°- 77°F)

protect from moisture, heat, and direct sunlight

see bottom of package for LOT and EXP

Inactive Ingredients

Aluminum Glycinate, Arnica Montana Flower Extract, Edetate Disodium, Ethylhexylglycerin, Glycerin, Kaolin, Phenoxyethanol,

Polyvinylpyrrolidone, Propylene Glycol, Sodium Carboxymethylcellulose, Sodium Polyacrylate, Tartaric Acid, Water

Principal Display Panel

Keep Out of Reach of Children

Keep out of reach of children and pets . lf swallowed get medical help or contact Poison

Control Center right away(1-800-222 -1222).


Structured Label Content

Use

for the temporary relief of minor aches and pains of muscles and joints associated with *Simple backache

*Arthritis *Strains *Bruises *Sprains

Purpose

Topical anesthetic

Topical Analgesic

Stop Use

localized skin reactions occur such as rash, itching, redness, irritation, pain, swelling or blistering

condition worsens

symptoms persist for more than 7 days or clear up and occur again within a few days

Warnings

For external use only

Questions

Questions or comments?

[email protected]

Ask Doctor

If pregnant or breast-feeding,ask a health professional before use.

Directions

Adults and children 12 years of age and over

apply 1 patch to clean, dry affected area

remove patch from backing and apply sticky side to affected area

wash hands thoroughly after applying

apply only 1 patch to affected area at a time

do not use more than 3 patches in 24 hours

remove patch after 8 hours; do not reuse

after use, fold patch so sticky sides adhere together and discard safely

Children under 12 years of age: ask a doctor

Do Not Use (Do not use)

more than one patch at a time

on wounds or damaged skin

with a heating pad or other heat source

with other ointments, creams, sprays, or liniments

for more than one week without consulting a doctor

if you have ever had an allergic reaction to this product or any of its ingredients

When Using

use only as directed

do not bandage tightly

avoid contact with eyes and mucous membranes

Active Ingredient

Lidocaine 4%

Menthol 1%

Other Information (Other information)

store at 20°- 25°C(68°- 77°F)

protect from moisture, heat, and direct sunlight

see bottom of package for LOT and EXP

Inactive Ingredients (Inactive ingredients)

Aluminum Glycinate, Arnica Montana Flower Extract, Edetate Disodium, Ethylhexylglycerin, Glycerin, Kaolin, Phenoxyethanol,

Polyvinylpyrrolidone, Propylene Glycol, Sodium Carboxymethylcellulose, 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 and pets . lf swallowed get medical help or contact Poison

Control Center right away(1-800-222 -1222).


Advanced Ingredient Data


Raw Label Data

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