SPL v3
SPL
SPL Set ID e9db590f-b19a-3fe8-e053-2995a90a4e74
Route
TOPICAL
Published
Effective Date 2022-09-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (200 mg) Menthol (60 mg)
Inactive Ingredients
Mineral Oil Water

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2022-09-30
Description

Methyl Salicylate, DL-Menthol

Medication Information

Warnings and Precautions

Warnings For external use only. Flammable ■ Keep away from fire, flame, sparks and heated surfaces. Tight cap firmly. Stop use and ask a doctor if ■ Condition worsens or symptoms persist for more than 7days or clear up and occur again within a few days When using this product ■ Use only as direct ■ Avoid contact with eyes ■ Do not apply to wounds or damaged skin ■ Do not bandage tightly If pregnant or breast-feeding, ask a health professional before use Keep out of reach of childre

Indications and Usage

■ Adults and children 2 years of age and older: apply to the affected area no more than 3 to 4 times daily ■ children under 2 years of age: consult a doctor

Dosage and Administration

topocal use

Description

Methyl Salicylate, DL-Menthol

Section 50565-1

Keep out of reach of children

Section 51727-6

mineral oil, lantrol, Sorbitan Monostearate, etc

Section 51945-4

Section 55105-1

temporary relief aches and pains of muscles and joints associated with: • arthritis • simple backache • sprains • strains • bruises

Section 55106-9

Methyl Salicylate, DL-Menthol

Structured Label Content

Indications and Usage (34067-9)

■ Adults and children 2 years of age and older: apply to the affected area no more than 3 to 4 times daily ■ children under 2 years of age: consult a doctor

Dosage and Administration (34068-7)

topocal use

Warnings and Precautions (34071-1)

Warnings For external use only. Flammable ■ Keep away from fire, flame, sparks and heated surfaces. Tight cap firmly. Stop use and ask a doctor if ■ Condition worsens or symptoms persist for more than 7days or clear up and occur again within a few days When using this product ■ Use only as direct ■ Avoid contact with eyes ■ Do not apply to wounds or damaged skin ■ Do not bandage tightly If pregnant or breast-feeding, ask a health professional before use Keep out of reach of childre

Section 50565-1 (50565-1)

Keep out of reach of children

Section 51727-6 (51727-6)

mineral oil, lantrol, Sorbitan Monostearate, etc

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

temporary relief aches and pains of muscles and joints associated with: • arthritis • simple backache • sprains • strains • bruises

Section 55106-9 (55106-9)

Methyl Salicylate, DL-Menthol

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:01:07.013961 · Updated: 2026-03-14T23:01:17.657881