Methyl Salicylate 25%

Methyl Salicylate 25% is an FDA-registered drug product whose active ingredient is METHYL SALICYLATE 25%. It is labelled by iON Pharma, LLC taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 82944-105, application 505G(a)(3), label effective 20260428. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing METHYL SALICYLATE 25% are most often described in connection with: temporarily relieves, aches pains, muscles joints, strains sprains, simple backache, arthritis bruises. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Uses Uses: Temporarily relieves aches & pains of muscles & joints associated with: Strains Sprains Simple Backache Arthritis Bruises

Directions section 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 affected area or 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 unless prescribed and instructed by a healthcare provider the used patch should be removed from the skin when a new one is applied.

Do not use section Warning: For external use only. Stomach bleeding warning: This product contains a 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 a 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 14 or more days right before or after heart surgery do not bandage tightly

What is Methyl Salicylate 25% used for?
Uses Uses: Temporarily relieves aches & pains of muscles & joints associated with: Strains Sprains Simple Backache Arthritis Bruises

Who makes Methyl Salicylate 25%?
iON Pharma, LLC is the labeler of record for Methyl Salicylate 25%.

What form does Methyl Salicylate 25% come in?
administered by topical. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Methyl Salicylate 25% prescription or over-the-counter?
The FDA label for this product is recorded as human otc drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Has Methyl Salicylate 25% been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.