Drug Facts

Drug Facts
SPL v16
SPL
SPL Set ID cba7c084-379f-4a16-aeba-b11ca6e20d8a
Route
TOPICAL
Published
Effective Date 2024-10-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (100 mg) Salicylic Acid (150 mg)
Inactive Ingredients
Citric Acid Monohydrate Glyceryl Monostearate Methylparaben Propylene Glycol Propylparaben Water Stearic Acid Trolamine Lanolin Polysorbate 80

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2012-06-01 Until 2026-12-01

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 or mucous membrane

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

Temporarily relieves the minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains.

Dosage and Administration

Use only as directed

Adults and children 12 years of age and older; apply to affected area not more than 3 to 4 times daily

Children under 12 years of age: ask a doctor

Description

Menthol Methyl Salicylate

Section 50565-1

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

Section 51727-6

Citric Acid, Glyceryl Monostearate, Lanolin, Methylparaben, Propylene Glycol, Propylparaben, Purified Water, Polysorbate 80, Stearic Acid, Trolamine

Section 51945-4

Section 55105-1

Topical analgesic

Section 55106-9

Menthol

Methyl Salicylate


Structured Label Content

Indications and Usage (34067-9)

Temporarily relieves the minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains.

Dosage and Administration (34068-7)

Use only as directed

Adults and children 12 years of age and older; apply to affected area not more than 3 to 4 times daily

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 or mucous membrane

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 to avoid accidental ingestion.If swallowed, get medical help or contact a Poison Control Center Immediately.

Section 51727-6 (51727-6)

Citric Acid, Glyceryl Monostearate, Lanolin, Methylparaben, Propylene Glycol, Propylparaben, Purified Water, Polysorbate 80, Stearic Acid, Trolamine

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)