Medicated Callus Removers

Medicated Callus Removers is an FDA-registered drug product whose active ingredient is SALICYLIC ACID. It is labelled by Premier Brands of America Inc taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 56104-913, application M030, label effective 20260527. It is one of 265 FDA drug label records sharing the active ingredient SALICYLIC ACID. 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 SALICYLIC ACID are most often described in connection with: removal calluses, relieves pain. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Uses for the removal of calluses relieves pain by removing calluses

Directions wash affected area and dry thoroughly if necessary, cut medicated patch to fit callus carefully adhere medicated patch direclty over callus cover medicated patch with pad after 48 hours, remove medicated patch repeat this procedure every 48 hours as needed for up to 14 days (until callus is removed) may soak callus in warm water for 5 minutes to assist in removal

Warnings For external use only. Do not use if you are a diabetic if you have poor blood circulation on irritated skin or on any area that is infected or reddened Stop use and ask a doctor if discomfort persists Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

FDA lists 265 drug label records with SALICYLIC ACID 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 Medicated Callus Removers used for?
Uses for the removal of calluses relieves pain by removing calluses

Who makes Medicated Callus Removers?
Premier Brands of America Inc is the labeler of record for Medicated Callus Removers. 265 FDA label records share the active ingredient SALICYLIC ACID, 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 Medicated Callus Removers 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 Medicated Callus Removers 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 SALICYLIC ACID?
Yes. 265 FDA drug label records list SALICYLIC ACID 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 Medicated Callus Removers 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.