Drug Facts

Drug Facts
SPL v5
SPL
SPL Set ID d066002d-8ceb-4d16-9744-d5ca25d2ad5a
Route
TOPICAL
Published
Effective Date 2025-06-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Levomenthol (100 mg) Salicylic Acid (150 mg)
Inactive Ingredients
Benzalkonium Chloride Citric Acid Monohydrate Glyceryl Monostearate Hydroxyethyl Acrylate/sodium Acryloyldimethyl Taurate Copolymer (100000 Mpa.s At 1.5%) Lanolin Polysorbate 80 Propylene Glycol Water Stearic Acid Potassium Hydroxide Xanthan Gum

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-12-12

Description

Menthol Methyl Salicylate


Medication Information

Warnings and Precautions

For external use only

Do not use:

On wounds or damaged skin

With a heating pad

On a child under 12 years of age with arthritis-like conditions

Ask a doctor before use if

you have redness over the affected area

When using this product

Avoid contact with eyes

Do not bandage tightly

Stop use and ask a doctor if

Condition worsens or symptoms persist for more than 7 days

Symptoms clear up and occur again within a few days

Excessive skin irritation occurs

Indications and Usage

For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains.

Dosage and Administration

Adults 12 years of age and older:

apply to affected area not more than 3 to 4 times daily

wash hands with soap and water after apply

Children under 12 years of age:ask a doctor

Description

Menthol Methyl Salicylate

Section 50565-1

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

Section 51727-6

Benzalkonium Chloride Solution, Citric Acid Monohydrate, Glyceryl Monostearate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Lanolin, Polysorbate 80, Propylene Glycol, Purified Water (Aqua), Stearic Acid, Potassium Hydroxide, Xanthan Gum

Section 51945-4

Section 55105-1

Topical analgesic

Section 55106-9

Menthol

Methyl Salicylate


Structured Label Content

Indications and Usage (34067-9)

For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains.

Dosage and Administration (34068-7)

Adults 12 years of age and older:

apply to affected area not more than 3 to 4 times daily

wash hands with soap and water after apply

Children under 12 years of age:ask a doctor

Warnings and Precautions (34071-1)

For external use only

Do not use:

On wounds or damaged skin

With a heating pad

On a child under 12 years of age with arthritis-like conditions

Ask a doctor before use if

you have redness over the affected area

When using this product

Avoid contact with eyes

Do not bandage tightly

Stop use and ask a doctor if

Condition worsens or symptoms persist for more than 7 days

Symptoms clear up and occur again within a few days

Excessive skin irritation occurs

Section 50565-1 (50565-1)

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

Section 51727-6 (51727-6)

Benzalkonium Chloride Solution, Citric Acid Monohydrate, Glyceryl Monostearate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Lanolin, Polysorbate 80, Propylene Glycol, Purified Water (Aqua), Stearic Acid, Potassium Hydroxide, Xanthan Gum

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Topical analgesic

Section 55106-9 (55106-9)

Menthol

Methyl Salicylate


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)