Label: METHYL SALICYLATE 10%- methyl salicylate patch

  • Category: HUMAN OTC DRUG LABEL

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated June 5, 2023

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

    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

    PRINCIPAL DISPLAY PANEL Methyl Salicylate 10% Patch

  • 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 not finalpart34806/01/2023
    Labeler - ION PHARMA, LLC (118739596)