UREDEX

UREDEX is an FDA-registered drug product whose active ingredient is UREA. It is labelled by Blue Heron Pharmaceuticals, LLC taken by topical and marketed as a human prescription drug product. Identifiers on file: NDC 85622-601, label effective 20260713. 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: promotion normal, healing hyperkeratotic, surface lesions, retarded local, infection necrotic, tissue fibrinous, purulent debris, eschar urea. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

INDICATIONS: For debridement and promotion of normal healing of hyperkeratotic surface lesions, particularly where healing is retarded by local infection, necrotic tissue, fibrinous or purulent debris or eschar. Urea is useful for the treatment of hyperkeratotic conditions such as dry, rough skin, dermatitis, psoriasis, xerosis, ichthyosis, eczema, keratosis pilaris, keratosis palmaris, keratoderma, corns and calluses, as well as damaged, ingrown and devitalized nails.

DOSAGE AND ADMINISTRATION: Apply to affected area(s) twice per day or as directed by a physician. Rub in until completely absorbed. Apply to diseased or damaged nail(s) twice per day, or as directed by a physician.

CONTRAINDICATIONS: This product is contraindicated in persons with known or suspected hypersensitivity to any of the ingredients of the product.

WARNING: KEEP OUT OF REACH OF CHILDREN.

ADVERSE REACTIONS: Transient stinging, burning, itching or irritation may occur and normally disappear upon discontinuing the use of this product.

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.

What is UREDEX used for?
INDICATIONS: For debridement and promotion of normal healing of hyperkeratotic surface lesions, particularly where healing is retarded by local infection, necrotic tissue, fibrinous or purulent debris or eschar. Urea is useful for the treatment of hyperkeratotic conditions such as dry, rough skin, dermatitis, psoriasis, xerosis, ichthyosis, eczema, keratosis pilaris, keratosis palmaris, …

Who makes UREDEX?
Blue Heron Pharmaceuticals, LLC is the labeler of record for UREDEX. 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 UREDEX 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 UREDEX prescription or over-the-counter?
The FDA label for this product is recorded as human prescription 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 UREDEX 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.