b6a6237d-b471-4102-b5df-fc389f5f9258

SPL v3
SPL
SPL Set ID b6a6237d-b471-4102-b5df-fc389f5f9258
Route
topical
Published
Effective Date 2023-11-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
salicylic acid (11 g) levomenthol (4 g) camphor (synthetic)
Inactive Ingredients
alcohol aminomethylpropanol arnica montana flower carbomer interpolymer type a (allyl sucrose crosslinked) cetostearyl alcohol ethylhexylglycerin phenoxyethanol glycerin polysorbate 80 water

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2023-02-16
Purpose

Topical Analgesic

Description

Camphor 4% Menthol 4% Methyl salicylate 11%

Medication Information

Warnings

For external use only



Do not use

  • on wounds or damaged skin
  • with a heating pad
  • on children 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

  • condition worsen or symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days
  • excessive skin irritation occurs

Keep out of reach of children.

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

Uses

Penetrating pain relief for the temporary relief of minor aches and pains of muscle and joint pain associated with arthritis, backache, strains, sprains and bruises.

Purpose

Topical Analgesic

Directions

Adults and children 12 years and over. Use no more than 3-4 times daily. Apply cream to affected areas and thoroughly massage until penetrated. Wash hands with soap and water after use.

Other Information

• Store at 59°F - 77°F

• If seal is broken, do not use

Inactive Ingredients

Alcohol Denat., Aminomethyl propanol, Arnica Montana Flower Extract, Carbopol Ultrez 10, Cetearyl Alcohol, Ethylhexylglycerin, Phenoxyethanol, Glycerin, Polysorbate 80, Water

Description

Camphor 4% Menthol 4% Methyl salicylate 11%

Section 50565-1

Drug Facts

Product Label

Active Ingredients

Camphor 4%

Menthol 4%

Methyl salicylate 11%

Questions Or Comments?

Call toll-free 1.888.829.7165

Structured Label Content

Warnings

For external use only



Do not use

  • on wounds or damaged skin
  • with a heating pad
  • on children 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

  • condition worsen or symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days
  • excessive skin irritation occurs

Keep out of reach of children.

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

Uses

Penetrating pain relief for the temporary relief of minor aches and pains of muscle and joint pain associated with arthritis, backache, strains, sprains and bruises.

Purpose

Topical Analgesic

Directions

Adults and children 12 years and over. Use no more than 3-4 times daily. Apply cream to affected areas and thoroughly massage until penetrated. Wash hands with soap and water after use.

Other Information (Other information)

• Store at 59°F - 77°F

• If seal is broken, do not use

Inactive Ingredients (Inactive ingredients)

Alcohol Denat., Aminomethyl propanol, Arnica Montana Flower Extract, Carbopol Ultrez 10, Cetearyl Alcohol, Ethylhexylglycerin, Phenoxyethanol, Glycerin, Polysorbate 80, Water

Section 50565-1 (50565-1)

Drug Facts

Product Label (Product label)

Active Ingredients (Active ingredients)

Camphor 4%

Menthol 4%

Methyl salicylate 11%

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: 2026-02-15T12:04:28.385877 · Updated: 2026-03-14T23:13:00.870746