METHYL SALICYLATE 25%- methyl salicylate cream

METHYL SALICYLATE 25% by

Drug Labeling and Warnings

METHYL SALICYLATE 25% by is a Otc medication manufactured, distributed, or labeled by Oncora Pharma, LLC, Pure Source LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Uses

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

WARNINGS

For external use only.

WHEN USING

When using this product

• Avoid contact with the eyes
• Do not bandage tightly

STOP USE

Stop use and ask a doctor if

• rash or irritation develops and lasts
• condition worsens
• if symptoms persist more than 7 days or clear up and occur again in a few days.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

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

PREGNANCY OR BREAST FEEDING

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

DOSAGE & ADMINISTRATION

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.

STORAGE AND HANDLING

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

ACTIVE INGREDIENT

Methyl Salicylate 25%

INACTIVE INGREDIENT

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

METHYL SALICYLATE 25% 
methyl salicylate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85477-301
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	250 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85477-301-10	118 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	06/11/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		06/11/2025

Labeler - Oncora Pharma, LLC (119482542)

Establishment
Name	Address	ID/FEI	Business Operations
Pure Source LLC		080354456	manufacture(85477-301)