SPL v3
SPL
SPL Set ID e0c9f22a-165a-4558-ba3c-8592f1bd0016
Route
TOPICAL
Published
Effective Date 2023-02-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (15 g) Menthol (8 g) Camphor (natural) (3 g)
Inactive Ingredients
Alcohol Arnica Montana Whole Bis-peg-12 Dimethicone (70 Mpa.s) Bis-peg-10 Dimethicone/dimer Dilinoleate Copolymer Water Eucalyptus Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-02-10
Description

Camphor 3% Menthol 8% Methyl salicylate 15%

Purpose

Topical Analgesic

Medication Information

Purpose

Topical Analgesic

Description

Camphor 3% Menthol 8% Methyl salicylate 15%

Uses

Provides penetrating pain relief for the temporary relief of minor aches and pains of muscles and joints

Section 50565-1

Warnings

For External Use Only. Flammable. Keep away from heat or flame.



Do not use:

• on wounds or damaged skin

• with a heating pad

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

When using this product avoid contact with eyes or mucous membranes, do not bandage tightly.



Stop use and ask a doctor if condition worsen or symptoms persist more than 7 days, symptoms clear up and occur again within a few days and/or excessive skin irritation occurs.



Keep out of reach of children

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

Directions

Adults and children 12 years and over: Spray evenly onto affected areas no more than 3 to 4 times daily. Apply spray to affected areas and

allowed to dry or thoroughly massage until penetrated. Wash hands with soap and water after use.

Drug Facts

Product Label

Other Information

• Store at 59°F - 77°F

Active Ingredients

Camphor 3%

Menthol 8%

Methyl salicylate 15%

Inactive Ingredients

Alcohol Denat., Arnica Montana Flower Extract, Bis-Peg 12 Dimethicone, Bis-Peg 10 Dimethicone, Water

Questions Or Comments?

Call toll-free 1.888.829.7165

Structured Label Content

Uses

Provides penetrating pain relief for the temporary relief of minor aches and pains of muscles and joints

Section 50565-1 (50565-1)

Purpose

Topical Analgesic

Warnings

For External Use Only. Flammable. Keep away from heat or flame.



Do not use:

• on wounds or damaged skin

• with a heating pad

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

When using this product avoid contact with eyes or mucous membranes, do not bandage tightly.



Stop use and ask a doctor if condition worsen or symptoms persist more than 7 days, symptoms clear up and occur again within a few days and/or excessive skin irritation occurs.



Keep out of reach of children

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

Directions

Adults and children 12 years and over: Spray evenly onto affected areas no more than 3 to 4 times daily. Apply spray to affected areas and

allowed to dry or thoroughly massage until penetrated. Wash hands with soap and water after use.

Drug Facts

Product Label (Product label)

Other Information (Other information)

• Store at 59°F - 77°F

Active Ingredients (Active ingredients)

Camphor 3%

Menthol 8%

Methyl salicylate 15%

Inactive Ingredients (Inactive ingredients)

Alcohol Denat., Arnica Montana Flower Extract, Bis-Peg 12 Dimethicone, Bis-Peg 10 Dimethicone, Water

Questions Or Comments? (Questions or comments?)

Call toll-free 1.888.829.7165

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:28.404352 · Updated: 2026-03-14T23:13:00.870746