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Urea 41% drug information

UREA
Oncora Pharma, LLC · TOPICAL

Product NDC: 85477-905

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Source label information, not individualized medical advice. This record applies to the product and labeler shown below. Compare the exact formulation, strength and country with your package and the current source label.
Generic nameUREA
Labeler / manufacturerOncora Pharma, LLC
RouteTOPICAL
Drug classDrug class not supplied in source label
Product NDC85477-905
Label effective date2025-06-11

Official product label reference

Urea 41% — Oncora Pharma, LLC

This page contains 7 source sections for UREA, topical route. Label set 37576876-738c-ac79-e063-6394a90a84fe, version 1.

Retrieved 2026-10-02 · openFDA dataset updated 2026-10-02 · Check the current DailyMed label

Label records can cover multiple strengths or package sizes. A label listing does not by itself establish FDA approval or current market availability. Check the source and application history for this specific product.

Uses described in the label

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 and administration — label text
DOSAGE AND ADMINISTRATION Apply Urea 41% 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.
Supply and packaging
HOW SUPPLIED Urea 41% Cream 8 oz. (227 g): NDC 85477-905-30
Safe handling warning
STORAGE Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from freezing and excessive heat. Keep container tightly closed. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Official sources and product identifiers

Substances listed: UREA

RxNorm identifiers: 1436933

Package NDC codes

85477-905-30

Further research and background

These are external searches for related information. Research, encyclopedia and news articles have not been imported into this product record.

Coverage and corrections

The text is extracted from a US structured product label. Tables are represented as text where supplied; formatting and illustrations may be lost. A missing section does not mean a risk is absent. This reference has not been independently reviewed by a clinician and is not a live safety-alert service.

Source retrieved 2026-10-02. Read the source policy.