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Dermacure (Umecta) Package Insert

Status:
Prescription (Rx) Facts
Strength:
410 mg/g
Brand names:
Active ingredient:
Similar drugs:

Source: FDA drug labeling via NLM DailyMed · About this document

Prescribing information (package insert) - Dermacure

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.

CONTRAINDICATIONS

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

WARNINGS

Avoid contact with eyes, lips and mucous membranes.

ADVERSE REACTIONS:

Discontinue use and consult a physician if redness or irritation occurs.

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.

HOW SUPPLIED

DERMACURE Urea 41% Cream 8 oz. (227 g): NDC 85477-909-30

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.

About this document

Source: FDA drug labeling via NLM DailyMed · View the label on DailyMed

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Drug information for Dermacure

Rx or OTC
Prescription (Rx)?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • Rx
Active ingredient Urea 410 mg/g
Dosage form Cream
Route Topical
Marketing status listed in the FDA NDC Directory
Company (applicant) Oncora Pharma, LLC
FDA approval UNAPPROVED DRUG OTHERUnapproved drug
Manufacturers 1 labelers list this drug on DailyMed
Packages (NDC)
Package
410 mg/g – 227 g in 1 jar NDC 85477-909-30

Source: FDA drug labeling via NLM DailyMed, data as of October 31, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.