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

Description

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

Purpose

Topical Analgesic


Medication Information

Purpose

Topical Analgesic

Description

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

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.

Section 50565-1

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. 

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.

Drug Facts

Product Label

Other Information

• Store at 59°F - 77°F

Active Ingredients

Camphor 4%, 

Menthol 4%, 

Methyl salicylate 11%

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


Structured Label Content

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.

Section 50565-1 (50565-1)

Purpose

Topical Analgesic

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. 

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.

Drug Facts

Product Label (Product label)

Other Information (Other information)

• Store at 59°F - 77°F

Active Ingredients (Active ingredients)

Camphor 4%, 

Menthol 4%, 

Methyl salicylate 11%

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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)