Label: METHYL SALICYLATE 10%- methyl salicylate patch

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated September 10, 2024

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • Drug Facts

  • Active ingredients:

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

  • Purpose

    Topical analgesic

  • Uses

    Temporarily relieves 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 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 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 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 36 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 (68-77°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

    Hypoallergenic Acrylic Adhesive

  • Questions or comments?

    833.711.8833

    • info@ionpharmausa.com
  • PRINCIPAL DISPLAY PANEL

    methyl salicylate jpg NDC 82944-101-10

    METHYL SALICYLATE 10%
    Topical Analgesic (NSAID)

    TOPICAL PAIN PATCH

    For Temporary Pain Relief

    Flexible Patch Innovation

    Soothing and Effective
    Long Lasting Relief

    WATER
    RESISTANT
    TECHNOLOGY

    Qty: 10 Flexible Patches
    (5 Per Resealable Pouch) x2
    3 x 5 (7.62cm x 12.7cm)

    APPLY FOR 36 HOURS

    ION PHARMA
    MADE IN
    USA

  • INGREDIENTS AND APPEARANCE
    METHYL SALICYLATE 10% 
    methyl salicylate patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82944-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE10 g
    Inactive Ingredients
    Ingredient NameStrength
    ACRYLIC ACID (UNII: J94PBK7X8S)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82944-101-1010 in 1 BOX06/01/2023
    15 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)06/01/2023
    Labeler - ION PHARMA, LLC (118739596)