Evara
Evara is an FDA drug label for the active ingredient UREA 40.5 CREAM manufactured by Oncora Pharma, LLC administered by TOPICAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20260501.
- Generic name
- UREA 40.5 CREAM
- Manufacturer
- Oncora Pharma, LLC
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- TOPICAL
- Dosage form
- N/A
- NDC
- 85477-308
- Application
- N/A
- Label effective
- 20260501
About this product
Evara is an FDA-registered drug product whose active ingredient is UREA 40.5 CREAM. It is labelled by Oncora Pharma, LLC taken by topical and marketed as a human prescription drug product. Identifiers on file: NDC 85477-308, label effective 20260501. 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.
What it is used for
Across FDA labelling, products containing UREA 40.5 CREAM are most often described in connection with: indications usage, promotion normal, healing hyperkeratotic, surface lesions, retarded local, infection necrotic, tissue brinous, purulent debris. Wording differs between labels, and the full indications section on this page takes precedence when it is present.
Indications & Usage
INDICATIONS & USAGE 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 eshar. 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 & Administration
DOSAGE AND ADMINISTRATION Apply Evara to affected skin twice per day, or as directed by your physician. Rub in until completely absorbed. Apply to diseased or damaged nail(s) twice per day, or as directed by a physician.
Contraindications
CONTRAINDICATIONS This product is contraindicated in persons with known or suspected hypersensitivity to any of the ingredients of the product.
Warnings
WARNINGS Avoid contact with eyes, lips and mucous membranes.
Adverse Reactions
ADVERSE REACTIONS: Discontinue use and consult a physician if redness or irritation occurs.
Frequently asked questions
What is Evara used for?
INDICATIONS & USAGE 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 eshar. 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 Evara?
Oncora Pharma, LLC is the labeler of record for Evara.
What form does Evara 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 Evara 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.
Has Evara 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.
This page reproduces FDA Structured Product Labelling data for identification and reference. It is not medical advice, does not diagnose or treat any condition, and does not sell or price any medicine.