SPL v2
SPL
SPL Set ID 43499e6c-e77e-b994-e063-6394a90a6151
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
Water Glycerin Polyacrylic Acid (300000 Mw) Polysorbate 80 Titanium Dioxide Polyvinyl Alcohol Propylene Glycol Sodium Polyacrylate (8000 Mw) Dihydroxyaluminum Aminoacetate Isopropyl Myristate Tartaric Acid Polyacrylic Acid (800000 Mw) Dmdm Hydantoin Edetic Acid

Identifiers & Packaging

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

Description

Menthol 5% w/w.


Medication Information

Warnings and Precautions

For external use only.

Indications and Usage

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

Dosage and Administration

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.

Description

Menthol 5% w/w.

Section 44425-7

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

Section 50565-1

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

Section 50567-7

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.

Section 50569-3

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.

Section 50570-1

On wounds, cuts, damaged or infected skin

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

If contact occurs, rinse thoroughly with water.

Section 51727-6

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

Section 51945-4

Section 53414-9

ask a health professional before use.

Section 55105-1

Topical analgesic

Section 55106-9

Menthol 5% w/w.


Structured Label Content

Indications and Usage (34067-9)

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

Dosage and Administration (34068-7)

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.

Warnings and Precautions (34071-1)

For external use only.

Section 44425-7 (44425-7)

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

Section 50565-1 (50565-1)

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

Section 50567-7 (50567-7)

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.

Section 50569-3 (50569-3)

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.

Section 50570-1 (50570-1)

On wounds, cuts, damaged or infected skin

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

If contact occurs, rinse thoroughly with water.

Section 51727-6 (51727-6)

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

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

ask a health professional before use.

Section 55105-1 (55105-1)

Topical analgesic

Section 55106-9 (55106-9)

Menthol 5% w/w.


Advanced Ingredient Data


Raw Label Data

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