SPL v2
SPL
SPL Set ID d4944ee3-23a3-f0b8-e053-2995a90a6ef1
Route
TOPICAL
Published
Effective Date 2018-11-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Camphor, (-)- (59 mg) Levomenthol (8 mg) Salicylic Acid (46 mg)
Inactive Ingredients
Acetone Chloroxylenol

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2022-01-02
Description

L-Menthol, L-Camphor, Methyl Salicylate

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 children

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

For external use only

Description

L-Menthol, L-Camphor, Methyl Salicylate

Section 50565-1

Keep out of reach of children

Section 51727-6

acetone, chloroxylenol, water

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

L-Menthol, L-Camphor, Methyl Salicylate

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)

For external use only

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 children

Section 50565-1 (50565-1)

Keep out of reach of children

Section 51727-6 (51727-6)

acetone, chloroxylenol, water

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)

L-Menthol, L-Camphor, Methyl Salicylate

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:01:07.012889 · Updated: 2026-03-14T23:01:17.657881