Urea 41% Cream

Urea 41% Cream
SPL v1
SPL
SPL Set ID 37576876-738c-ac79-e063-6394a90a84fe
Route
TOPICAL
Published
Effective Date 2025-06-11
Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Urea (410 mg)
Inactive Ingredients
Ceteareth-20 Cetyl Alcohol Paraffin Propylene Glycol Water C13-14 Isoparaffin Xanthan Gum Polyacrylamide (10000 Mw) Phenoxyethanol Laureth-7 Ethylhexylglycerin

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2025-06-11

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.

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


Medication Information

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.

Warnings

Avoid contact with eyes, lips and mucous membranes.

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

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.

Warnings (WARNINGS)

Avoid contact with eyes, lips and mucous membranes.

How Supplied (HOW SUPPLIED)

Urea 41% Cream 8 oz. (227 g): NDC 85477-905-30

Contraindications (CONTRAINDICATIONS)

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

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.

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.


Advanced Ingredient Data


Raw Label Data

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