urea 41% cream
37576876-738c-ac79-e063-6394a90a84fe
34391-3
HUMAN PRESCRIPTION DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
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
This product is contraindicated in persons with known or suspected hypersensitivity to any of the ingredients of the product.
Adverse Reactions
Discontinue use and consult a physician if redness or irritation occurs.
How Supplied
Urea 41% Cream 8 oz. (227 g): NDC 85477-905-30
Description
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.
Medication Information
Warnings
Avoid contact with eyes, lips and mucous membranes.
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
This product is contraindicated in persons with known or suspected hypersensitivity to any of the ingredients of the product.
Adverse Reactions
Discontinue use and consult a physician if redness or irritation occurs.
How Supplied
Urea 41% Cream 8 oz. (227 g): NDC 85477-905-30
Description
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.
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.
Urea 41% Cream™
Distributed by
Oncora Pharma
Dallas, TX 75161
Adverse Reactions:
Discontinue use and consult a physician if redness or irritation occurs.
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.
Structured Label Content
Warnings (WARNINGS)
Avoid contact with eyes, lips and mucous membranes.
Dosage and Administration (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.
How Supplied (HOW SUPPLIED)
Urea 41% Cream 8 oz. (227 g): NDC 85477-905-30
Storage (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.
Urea 41% Cream™
Distributed by
Oncora Pharma
Dallas, TX 75161
Adverse Reactions: (ADVERSE REACTIONS:)
Discontinue use and consult a physician if redness or irritation occurs.
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.
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Raw Label Data
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Additional Information
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Source: dailymed · Ingested: 2026-02-15T11:47:37.528343 · Updated: 2026-03-14T22:27:42.927819