Mederma Advanced Scar

Mederma Advanced Scar is an FDA-registered drug product whose active ingredient is ALLANTOIN. It is labelled by PMI Branded Pharmaceuticals, Inc. taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 73302-201, application M016, label effective 20260716. It is one of 9 FDA drug label records sharing the active ingredient ALLANTOIN. 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 ALLANTOIN are most often described in connection with: temporarily protects, helps relieve, chapped cracked. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Uses • Temporarily protects and helps relieve chapped or cracked skin

Directions • Apply as needed

Warnings • For external use only When using this product • Do not get into eyes Stop use and ask a doctor if • Condition worsens • Symptoms last more than 7 days or clear up and occur again within a few days Do not use on • Deep puncture wounds • Animal bites • Serious burns Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

FDA lists 9 drug label records with ALLANTOIN 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 Mederma Advanced Scar used for?
Uses • Temporarily protects and helps relieve chapped or cracked skin

Who makes Mederma Advanced Scar?
PMI Branded Pharmaceuticals, Inc. is the labeler of record for Mederma Advanced Scar. 9 FDA label records share the active ingredient ALLANTOIN, 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 Mederma Advanced Scar 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 Mederma Advanced Scar 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 ALLANTOIN?
Yes. 9 FDA drug label records list ALLANTOIN 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 Mederma Advanced Scar 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.