Label: METHYL SALICYLATE 25%- methyl salicylate cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated July 1, 2025

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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.

  • 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

    label

  • INGREDIENTS AND APPEARANCE
    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)
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