83559-003

83559-003
SPL v2
SPL
SPL Set ID 159266a8-94fa-e2ff-e063-6394a90a9a77
Route
TOPICAL
Published
Effective Date 2024-04-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (5 g)
Inactive Ingredients
Glycerin Carboxymethylcellulose Sodium, Unspecified Form Titanium Dioxide Dihydroxyaluminum Aminoacetate Anhydrous Water Povidone Tartaric Acid Ethylhexylglycerin Phenoxyethanol Edetate Disodium Sodium Acrylate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-04-07

Description

Menthol 5%

Purpose

Topical analgesic


Medication Information

Purpose

Topical analgesic

Description

Menthol 5%

Use

temporarily relieves minor aches and pains of muscles and joints associated with:■simple backache■arthritis■ strains■bruises ■sprains

Stop Use

Stop use and ask a doctor if

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

■ conditions worsen

■ symptoms persist for more than 7 days

■ symptoms clear up and occur again within a few days

Warnings

For external use only

Questions

Call 718-975-2586

Ask Doctor

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

Directions

Adults and children 12 years of age and over:

■ clean and dry affected area

■ remove film from patch and apply to the skin

■ apply 1 patch at a time to affected area, not more than 3 to 4 times daily

■ remove patch from the skin after at most 8 hours of application

Children under 12 years of age: consult a doctor

Do Not Use

■ on wounds or damaged skin with a heating pad

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

When Using

When using this product

■ use only as directed

■ avoid contact with the eyes mucous membranes or rashes ■ do not bandage tightly

Active Ingredient

Menthol 5%

Other Information

■ avoid storing product in direct sunlight

■ protect product from excessive moisture

■ store at 20-25°C(68-77°F)

Inactive Ingredients

Aluminum Glycinate, Edetate Disodium, Ethylhexylglycerin, Glycerin, Phenoxyethanol, Polyvinylpyrrolidone, Sodium Carboxymethylcellulose, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Water

Principal Display Panel

Keep Out of Reach of Children

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


Structured Label Content

Use

temporarily relieves minor aches and pains of muscles and joints associated with:■simple backache■arthritis■ strains■bruises ■sprains

Purpose

Topical analgesic

Stop Use

Stop use and ask a doctor if

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

■ conditions worsen

■ symptoms persist for more than 7 days

■ symptoms clear up and occur again within a few days

Warnings

For external use only

Questions

Call 718-975-2586

Ask Doctor

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

Directions

Adults and children 12 years of age and over:

■ clean and dry affected area

■ remove film from patch and apply to the skin

■ apply 1 patch at a time to affected area, not more than 3 to 4 times daily

■ remove patch from the skin after at most 8 hours of application

Children under 12 years of age: consult a doctor

Do Not Use (Do not use)

■ on wounds or damaged skin with a heating pad

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

When Using

When using this product

■ use only as directed

■ avoid contact with the eyes mucous membranes or rashes ■ do not bandage tightly

Active Ingredient

Menthol 5%

Other Information (Other information)

■ avoid storing product in direct sunlight

■ protect product from excessive moisture

■ store at 20-25°C(68-77°F)

Inactive Ingredients (Inactive ingredients)

Aluminum Glycinate, Edetate Disodium, Ethylhexylglycerin, Glycerin, Phenoxyethanol, Polyvinylpyrrolidone, Sodium Carboxymethylcellulose, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Water

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

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.


Advanced Ingredient Data


Raw Label Data

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