Methyl Salicylate 10%

Methyl Salicylate 10% is an FDA-registered drug product whose active ingredient is METHYL SALICYLATE. It is labelled by ION PHARMA, LLC taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 82944-101, application 505G(a)(3), label effective 20260428. It is one of 5 FDA drug label records sharing the active ingredient METHYL SALICYLATE. 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 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 Temporarily relieves aches & pains of muscles & joints associated with: Strains Sprains Simple Backache Arthritis Bruises

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

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.

FDA lists 5 drug label records with METHYL SALICYLATE as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

What is Methyl Salicylate 10% used for?
Uses Temporarily relieves aches & pains of muscles & joints associated with: Strains Sprains Simple Backache Arthritis Bruises

Who makes Methyl Salicylate 10%?
ION PHARMA, LLC is the labeler of record for Methyl Salicylate 10%. 5 FDA label records share the active ingredient METHYL SALICYLATE, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does Methyl Salicylate 10% 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 10% 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.

Are there other products containing METHYL SALICYLATE?
Yes. 5 FDA drug label records list METHYL SALICYLATE as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has Methyl Salicylate 10% 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.