Label: METHYL SALICYLATE 10%- methyl salicylate patch

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

Drug Label Information

Updated June 7, 2025

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

View All Sections
  • ​

    Drug Facts

  • Active ingredients:

    Methyl Salicylate 10% (NSAID: nonsteroidal anti-inflammatory drug)

  • Purpose

    External analgesic

  • Uses

    Temporarily relieves aches & pains of muscles & joints associated with:

    • Stains
    • 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 as NSAID (aspirin, ibuprofen, naproxen, or others)
    • have 3 or more alcoholic drinks every day while using this product

    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)
    • any patch from a pouch that has been open for 14 or more days
    • right before or after heat surgery

    Ask a doctor before use if

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

    When using this product

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

    Stop 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 right away. Package not child resistant. Dispose of the used patches after folding sticky ends together.

  • Directions

    Adults and Children 10 years of age and older:

    • only use one patch at a time
    • clean and dry affected area
    • remove patch from backing film and apply to skin (see illustration)
    • apply 1 patch to the affective area of intact skin up to 24 hours.
    • do not use more than 2 patches per day  do not use for more than 3 days in a row
    • the used patch should be removed from the skin when a new one is applied
  • Other information

    • Store at 20-25°C (66-77°F)
    • Avoid storing product in direct sunlight
    • Protect product from excessive moisture
    • Some individuals may not experience pain relief until several hours after applying the patch
  • Inactive ingredients

    Alpha Tocopherol Acetate, Aluminum Glycinate, Aluminum Hydroxide, Aluminum Sulphate, Borax, Carbomer, Collodial Silicon Dioxide, DMDM Hydantoin, Glycerin, Kaolin, Polyacrylic Acid, Polyvinyl Alcohol, Polyvinylpyrrolidone, Propylene Glycol, Purified Water, Sodium Carboxymethyl Cellulose, Sodium Propylene Glycol, Sodium Polyacrylate, Sorbitol, Sorbitan Monooleate, Tartric Acid & Titanium Dioxide 

  • Questions or comments?

    Call 877-227-3137

  • PRINCIPAL DISPLAY PANEL

    methyl salicylate jpg

    NDC 85231-101-15

    METHYL SALICYLATE 10%
    Topical Analgesic (NSAID)

    Pain Relieving Gel Patch

    Soothing and Effective Long Lasting Relief

    24 Hour Application

    15 Patches

    3.94 in x 5.5 in EACH

    Packaged For:

    ViolaCare Inc.

    Parsippany, New Jersey, 07054

  • INGREDIENTS AND APPEARANCE
    METHYL SALICYLATE 10% 
    methyl salicylate patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:85231-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE10 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    KAOLIN (UNII: 24H4NWX5CO)  
    POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)  
    POLYVINYL ALCOHOL (100000 MW) (UNII: 949E52Z6MY)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
    SORBITOL (UNII: 506T60A25R)  
    SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
    TARTARIC ACID (UNII: W4888I119H)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:85231-101-1515 in 1 BOX05/01/2025
    11 in 1 POUCH
    110 g in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)05/01/2025
    Labeler - ViolaCare, Inc. (119452160)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!