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Urea 41 drug information

UREA 41
Oncora Pharma, LLC · TOPICAL

Product NDC: 85477-306

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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 41
Labeler / manufacturerOncora Pharma, LLC
RouteTOPICAL
Drug classDrug class not supplied in source label
Product NDC85477-306
Label effective date2026-03-06

Official product label reference

Urea 41 — Oncora Pharma, LLC

This page contains 5 source sections for UREA 41, topical route. Label set ff306984-a52b-48d8-88a8-3a4c72109e63, 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 AND USAGE Urea 41% Cream is indicated 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. It is also indicated for the treatment of hyperkeratotic conditions such as: dry, rough skin dermatitis psoriasis xerosis ichthyosis eczema keratosis pilaris keratosis palmaris keratoderma corns and calluses damaged, ingrown, or devitalized nails
Dosage and administration — label text
DOSAGE AND ADMINISTRATION Apply Urea 41% Cream to affected area(s) twice daily or as directed by a physician. Rub into the skin until completely absorbed. For nail conditions, apply to diseased or damaged nails twice daily or as directed by a physician.
Warnings
WARNINGS For external use only. Avoid contact with eyes, lips, or mucous membranes. Discontinue use and consult a physician if redness, irritation, or sensitivity occurs. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.
Product description
DESCRIPTION Urea 41% Cream used to soften and moisturize dry, rough, and hyperkeratotic skin.
Supply and packaging
HOW SUPPLIED Urea 41% Cream is supplied as: 8 oz (227 g) container NDC: 85477-306-27 Dispensed by prescription.

Official sources and product identifiers

Substances listed: UREA

Package NDC codes

85477-306-27

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.