SPL v1
SPL
SPL Set ID 434c13c2-52ee-000f-e063-6294a90af7e7
Route
TOPICAL
Published
Effective Date 2025-11-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (5 g)
Inactive Ingredients
Polyvinyl Alcohol Isopropyl Myristate Titanium Dioxide Polysorbate 80 Glycerin Polyacrylic Acid (800000 Mw) Tartaric Acid Edetic Acid Dihydroxyaluminum Aminoacetate Polyacrylic Acid (300000 Mw) Propylene Glycol Water Dmdm Hydantoin Sodium Polyacrylate (8000 Mw)

Identifiers & Packaging

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

Description

Menthol 5% w/w.

Purpose

Topical analgesic

Storage and Handling

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


Medication Information

Purpose

Topical analgesic

Storage and Handling

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

Description

Menthol 5% w/w.

Use

Temporary relives of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, sprains.

Image

Warnings

For external use only.

Directions

Adults and children 12 years of age and older:

Carefully remove backing from patch

Apply sticky side of patch to affected area.

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

Repeat as necessary, but no more than 3 times daily .

Discard patch after single use.

Children under 12 years of age: do not use, consult a physician.

Supervise children when they use this product.

Do Not Use

On wounds, cuts, damaged or infected skin

On eyes, mouth, genitals, or any other mucous membranes

If contact occurs, rinse thoroughly with water.

Active Ingredient(s)

Menthol 5% w/w.

Inactive Ingredients

Dihydroxyaluminum aminoacetate, DMDM hydantoin, Edetic acid, Glycerin, Isopropyl myristate, Polyacrylic acid, Polysorbate 80, Polyvinyl alcohol, Propylene glycol, Sodium polyacrylate, Tartaric acid, Titanium dioxide, Water

When Using This Product:

Use only as directed

Rear cases of serious burns have been reported with products of this type

Do not bandage tightly or use with a heating pad such as an electric heating pad, as this may result in excessive skin irritation or skin burn

Avoid contact with eyes and mucous membranes

Do not apply to wounds or damaged skin.

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

If Pregnant Or Breastfeeding

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

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:

Condition worsens

Redness is present

Irritation develops

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

You experience signs of skin injury, such as pain, swelling or blistering where the product was applied as rare but the serious burns can occur.


Structured Label Content

Use

Temporary relives of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, sprains.

Image (IMAGE)

Purpose

Topical analgesic

Warnings

For external use only.

Directions

Adults and children 12 years of age and older:

Carefully remove backing from patch

Apply sticky side of patch to affected area.

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

Repeat as necessary, but no more than 3 times daily .

Discard patch after single use.

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)

On wounds, cuts, damaged or infected skin

On eyes, mouth, genitals, or any other mucous membranes

If contact occurs, rinse thoroughly with water.

Active Ingredient(s)

Menthol 5% w/w.

Inactive Ingredients (Inactive ingredients)

Dihydroxyaluminum aminoacetate, DMDM hydantoin, Edetic acid, Glycerin, Isopropyl myristate, Polyacrylic acid, Polysorbate 80, Polyvinyl alcohol, 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

Rear cases of serious burns have been reported with products of this type

Do not bandage tightly or use with a heating pad such as an electric heating pad, as this may result in excessive skin irritation or skin burn

Avoid contact with eyes and mucous membranes

Do not apply to wounds or damaged skin.

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 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: (Stop use and ask a doctor if:)

Condition worsens

Redness is present

Irritation develops

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

You experience signs of skin injury, such as pain, swelling or blistering where the product was applied as rare but the serious burns can occur.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)