37368566-b14e-4d5c-bdde-6eea9073974f

SPL v1
SPL
SPL Set ID 37368566-b14e-4d5c-bdde-6eea9073974f
Route
topical
Published
Effective Date 2025-06-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
salicylic acid (11 g) menthol (4 g) camphor (natural)
Inactive Ingredients
water rice bran oil cetyl alcohol isopropyl palmitate sodium hydroxide glycerin eucalyptus oil arnica montana carbomer copolymer type a ceteth-10 phosphate dihexadecyl phosphate dimethyl sulfone diethylene glycol monophenyl ether

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2025-06-20

Purpose

Topical Analgesic

Description

Camphor 4%,  Menthol 4%,  Methyl salicylate 11%


Medication Information

Warnings

For external use only. Do not apply to vulva or vagina.



 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
  • do not point towards face while squeezing

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 Control 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 older. 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

Inactive Ingredients

water, rice bran oil, cetyl alcohol, isopropyl palmitate, sodium hydroxide, glycerin, eucalyptus oil, arnica montana, carbomer copolymer type a, ceteth-10 phosphate, dihexadecyl phosphate, dimethyl sulfone, dimethyl sulfone, diethylene glycol monophenyl ether

Description

Camphor 4%,  Menthol 4%,  Methyl salicylate 11%

Section 50565-1

Drug Facts

Product Label

Active Ingredients

Camphor 4%, 

Menthol 4%, 

Methyl salicylate 11%


Structured Label Content

Warnings

For external use only. Do not apply to vulva or vagina.



 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
  • do not point towards face while squeezing

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 Control 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 older. 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

Inactive Ingredients (Inactive ingredients)

water, rice bran oil, cetyl alcohol, isopropyl palmitate, sodium hydroxide, glycerin, eucalyptus oil, arnica montana, carbomer copolymer type a, ceteth-10 phosphate, dihexadecyl phosphate, dimethyl sulfone, dimethyl sulfone, diethylene glycol monophenyl ether

Section 50565-1 (50565-1)

Drug Facts

Product Label (Product label)

Active Ingredients (Active ingredients)

Camphor 4%, 

Menthol 4%, 

Methyl salicylate 11%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)