Label: METHYL SALICYLATE cream

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

Drug Label Information

Updated May 15, 2024

If you are a consumer or patient please visit this version.

  • Active Ingredient                                                                                     Purpose

    Methyl Salicylate 25% (NSAID: Nonsteroidal anti-inflammatory drug)            Topical Analgesic

  • PURPOSE

  • Uses

    Temporarily relieves mild to moderate aches & pains of muscles & joints associated with:

    • strains • sprains • simple backache • arthritis • bruises

  • Warnings

    For external use only
    Stomach bleeding warning: This product contains an NSAID, which may cause stomach bleeding.
    The chance is small but higher if you:

    • are age 60 or older • have had stomach ulcers or bleeding problems
    • take a blood thinning (anticoagulant) or steroid drug
    • take other drugs containing an NSAID (aspirin, ibuprofen, naproxen, or others]
    • have 3 or more alcoholic drinks every day while using this product • take more or for a longer time than directed

    Do not use

    • on the face or rashes • on wounds or damaged skin • if allergic to aspirin or other NSAIDs
    • with a heating pad • when sweating (such as from exercise or heat)
    • right before or after heart surgery

    Ask a doctor before use if
    • you are allergic to topical products • the stomach bleeding warning applies to you
    • you have high blood pressure, heart disease, or kidney disease • you are taking a diuretic

    When using this product

    • wash hands after applying or removing patch. Avoid contact with eyes. If eye contact occurs, rinse thoroughly with water.
    • the risk of heart attack or stroke may increase if you use more than directed or for longer than directed

    Stop use and ask a doctor if
    • stomach pain or upset gets worse or lasts • you feel faint, vomit blood, or have bloody or black stools
    These are signs of stomach bleeding. • rash, itching or skin irritation develops
    • condition worsens
    • symptoms last for more than 3 days • symptoms clear up and occur again within a few days

    If pregnant or breast-feeding,

    ask a doctor before use while breast-feeding and during the first 6 months of pregnancy. Do not use during the last 3 months of pregnancy because it may cause problems in the unborn child or complications during delivery.
    Keep out of reach of children. If put in mouth, get medical help or contact a Poison Control Center right away. Package not child resistant. Dispose of the used patches after folding sticky ends together.

  • KEEP OUT OF REACH OF CHILDREN

  • Directions

     • Use only as directed
    Adults and children 12 years of age and older: Apply to affected area not more than 3 to 4 times daily •children under 12 years of age: consult a physician

  • Other information

    • Store at 20-25°C (68-77°F) • Avoid storing product in direct sunlight
    •Protect product from excessive moisture

  • Inactive ingredients

    Aqua (deionized water), arnica montana (arnica) extract, boswellia serrata extract, cetearyl olivate, cetyl alcohol, dimethyl sulfone (MSM), ethylhexylglycerin, glycerin, glyceryl stearate, hemp, PEG-100 stearate, phenoxyethanol, polysorbate-20, resveratrol, sodium laurylglucosides hydroxypropylsulfonate, sorbital olivate, stearic acid

  • Product label

    image description

  • INGREDIENTS AND APPEARANCE
    METHYL SALICYLATE 
    methyl salicylate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79643-004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE250 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)  
    CETEARYL OLIVATE (UNII: 58B69Q84JO)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    HEMP (UNII: TD1MUT01Q7)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    RESVERATROL (UNII: Q369O8926L)  
    SODIUM LAURYLGLUCOSIDES HYDROXYPROPYLSULFONATE (UNII: Z6GFR7R72Y)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79643-004-01100 g in 1 TUBE; Type 0: Not a Combination Product05/01/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01705/01/2024
    Labeler - PHARMACURE LLC (055983858)