Urea 40

Urea 40 is an FDA-registered drug product whose active ingredient is UREA. It is labelled by Krewe Pharma, LLC taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 87021-603, label effective 20260602. It is one of 7 FDA drug label records sharing the active ingredient UREA. 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 UREA are most often described in connection with: very dry, usage intensely, skin-softening cream, urea helps, thickened skin, targeted application, hardened thick, rough patches. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Usage: Intensely exfolitating and skin-softening cream with Urea 40%. Helps smooth and soften very, dry, rough, and thickened skin. Suitable for targeted application on areas with very dry, hardened or thick skin, rough patches and calluses, uneven, scaly, or flaky skin texture and thickened nail surface appearance. Helps soften and improve the cosmetic appearance of thickened or irregular nails.

Apply Urea 40% Cream to affected area(s) twice per day, or as directed by your physician. Rub in until completely absorbed.

WARNINGS SECTION Caution: Discontinue use and consult a physician if redness or Irritation occurs. When using this product avoid contact with eyes, lips or mucous membranes.

FDA lists 7 drug label records with UREA 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.

2 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.

What is Urea 40 used for?
Usage: Intensely exfolitating and skin-softening cream with Urea 40%. Helps smooth and soften very, dry, rough, and thickened skin. Suitable for targeted application on areas with very dry, hardened or thick skin, rough patches and calluses, uneven, scaly, or flaky skin texture and thickened nail surface appearance. Helps soften and improve the cosmetic appearance of thickened or irregular nails.

Who makes Urea 40?
Krewe Pharma, LLC is the labeler of record for Urea 40. 7 FDA label records share the active ingredient UREA, 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 Urea 40 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 Urea 40 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 UREA?
Yes. 7 FDA drug label records list UREA 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 Urea 40 been recalled?
2 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.

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.