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Urea 40 Percent

Generic: Urea

Verified·Apr 23, 2026
NDC
72162-1668
RxCUI
198342
Route
TOPICAL
ICD-10 indication
L85.0

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About Urea 40 Percent

What is this medication? Urea 40 percent is a high-potency topical medication classified as a keratolytic agent, which means it helps break down and soften thickened or hardened skin. It is primarily prescribed to treat hyperkeratotic conditions such as psoriasis, eczema, ichthyosis, and severe calluses or corns. By increasing the moisture content of the skin and dissolving the protein matrix that holds dead skin cells together, this medication promotes the shedding of rough skin and restores a smoother texture to affected areas. In addition to treating skin conditions, urea 40 percent is frequently used for the non-surgical debridement of damaged or diseased nails. When applied to the nails, it helps soften and thin the nail plate, making it easier to remove sections affected by fungal infections or physical trauma. This process allows for better penetration of subsequent antifungal treatments and can help relieve pressure associated with thickened or ingrown nails. The medication is for external use only and should be applied exactly as directed by a healthcare professional.

Copay & patient assistance

  • Patient Copay Amount: Not Publicly Available
  • Maximum Annual Benefit Limit: Not Publicly Available
  • Core Eligibility Restrictions: Not Publicly Available
  • RxBIN, PCN, and Group numbers: Not Publicly Available

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Prescribing information

From the FDA-approved label for Urea 40 Percent. Official source: DailyMed (NLM) · Label effective Mar 27, 2026

Indications and usage
INDICATIONS: This product is useful for the treatment of hyperkeratotic conditions such as dry, rough skin, xerosis, ichthyosis, skin cracks and fissures, dermatitis, eczema, psoriasis, keratoses and calluses.
Dosage and administration
DOSAGE AND ADMINISTRATION: Use as directed by your physician. See label booklet for full Prescribing Information.
Contraindications
CONTRAINDICATIONS: This product is contraindicated in persons with known or suspected hypersensitivity to any of the ingredients of the product.
Warnings
WARNINGS: FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. KEEP OUT OF REACH OF CHILDREN. Avoid contact with eyes, lips and mucous membranes. General: This product is to be used as directed by a physician and should not be used to treat any condition other than that for which it was prescribed. If redness or irritation occurs, discontinue use and consult a physician. Information for Patients: Patients should discontinue the use of this product if the condition becomes worse or if a rash develops in the area being treated or elsewhere. Avoid contact with eyes, lips and mucous membranes. Carcinogenesis, Mutagenesis and Impairment of Fertility: Long-term animal studies for carcinogenic potential have not been performed on this product to date. Studies on reproduction and fertility also have not been performed. Pregnancy: Category C . Animal reproduction studies have not been conducted with this product. It is also not known whether this product can affect reproduction capacity or cause fetal harm when administered to a pregnant woman. This product should be used by a pregnant woman only if clearly needed or when potential benefits outweigh potential hazards to the fetus. Nursing Mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when this product is administered to a nursing woman.
Adverse reactions
ADVERSE REACTIONS: Transient stinging, burning, itching or irritation may occur and normally disappear upon discontinuing the use of this product.
Use in pregnancy
Pregnancy: Category C . Animal reproduction studies have not been conducted with this product. It is also not known whether this product can affect reproduction capacity or cause fetal harm when administered to a pregnant woman. This product should be used by a pregnant woman only if clearly needed or when potential benefits outweigh potential hazards to the fetus.

Label text is reproduced as-is from the FDA-approved label. We do not paraphrase, summarize, or omit. Content above is for informational purposes only and is not medical advice. Always consult your prescribing clinician or pharmacist before making decisions about your medication.

Conditions we've indexed resources for

Click a condition to see copay cards, grants, and PA rules specific to it. For the full list of FDA-approved indications, see Prescribing information above.

Prior authorization & coverage

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How this page is sourced

  • Drug identity verified against openFDA NDC Directory.
  • Label text (when shown) originates from NLM DailyMed.
  • Copay and assistance URLs verified periodically; if you hit a broken link, tell us.

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