METHYL SALICYLATE 25%- methyl salicylate cream 
Oncora Pharma, LLC

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Uses

For the temporary relief of minor aches and pains of muscles and joints, associated with simpled backache, arthritis, strains, bruises and sprains.

For external use only.

When using this product

Stop use and ask a doctor if

Keep out of reach of children

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

If pregnant or breast-feeding, ask a health professional before use.

Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily.

Children under 2 years of age, consult a doctor.

Protect the product in this container from excessive heat and direct sun.

Methyl Salicylate 25%

Arnica Montana Extract, Cetearly Alcohol, Dimethyl Sulfone, Ethylhexylglycerin, Glucosamine Sulfate, Glycerin, Glyceryl Stearate, Isostearyl Palmitate, PEG-100 Stearate, Phenoxyethanol, Propylene Glycol, Silica, Sodium Chondroitin Sulfate, Sodium Polyacrylate, Stearic Acid, Triethanolamine, Water

Purpose

Topical Analgesic

label

METHYL SALICYLATE 25% 
methyl salicylate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:85477-301
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE250 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)  
GLYCERYL STEARATE (UNII: 230OU9XXE4)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TRIETHANOLAMINE (UNII: 9O3K93S3TK)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ARNICA MONTANA (UNII: O80TY208ZW)  
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
SODIUM CHONDROITIN SULFATE (PORCINE; 5500 MW) (UNII: H5BJH23Z9A)  
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
PEG-100 STEARATE (UNII: YD01N1999R)  
CETEARYL ALCOHOL (UNII: 2DMT128M1S)  
ISOSTEARYL PALMITATE (UNII: 9EHU0R7ER1)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:85477-301-10118 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/11/2025
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01706/11/2025
Labeler - Oncora Pharma, LLC (119482542)
Establishment
NameAddressID/FEIBusiness Operations
Pure Source LLC080354456manufacture(85477-301)

Revised: 7/2025
Document Id: 38e43dff-f89e-6248-e063-6294a90aaaf1
Set id: 3766e3a9-94a8-4c3e-e063-6394a90aa24a
Version: 2
Effective Time: 20250701
 
Oncora Pharma, LLC