Eagle Brand Medicated Roll On

Eagle Brand Medicated Roll On is an FDA-registered drug product whose active ingredient is MENTHOL, METHYL SALICYLATE. It is labelled by PT. EAGLE INDO PHARMA taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 60954-020, application M017, label effective 20260428. It is one of 12 FDA drug label records sharing the active ingredient MENTHOL, 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 MENTHOL, METHYL SALICYLATE are most often described in connection with: temporarily relieves, minor aches, pains muscles, joints associated, simple backache, strains bruises. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Uses Temporarily relieves the minor aches and pains of muscles and joints associated with: simple backache strains bruises sprains

Directions Use only as directed adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily children under 2 years of age: ask a doctor

Warnings For external use only Do not use on wounds or damage skin with a heating pad Ask a doctor before use if you have redness over affected area When using this product avoid contact with eyes or mucous membranes do not bandage tightly Stop use and ask a doctor if condition worsens or symptoms persist for more than 7 days symptoms clear up and occur again within a few days excessive skin irritation occurs Keep out of reach of children Avoid accidental poisoning. If swallowed, get medical help or contact a Poison Control Center right away.

FDA lists 12 drug label records with MENTHOL, 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 Eagle Brand Medicated Roll On used for?
Uses Temporarily relieves the minor aches and pains of muscles and joints associated with: simple backache strains bruises sprains

Who makes Eagle Brand Medicated Roll On?
PT. EAGLE INDO PHARMA is the labeler of record for Eagle Brand Medicated Roll On. 12 FDA label records share the active ingredient MENTHOL, 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 Eagle Brand Medicated Roll On 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 Eagle Brand Medicated Roll On 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 MENTHOL, METHYL SALICYLATE?
Yes. 12 FDA drug label records list MENTHOL, 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 Eagle Brand Medicated Roll On 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.