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Urea 41 Package Insert

Status:
Prescription (Rx) Facts
Strength:
41 mg/g
Active ingredient:

Prescribing information (package insert) - Urea 41

DESCRIPTION

Urea 41% Cream used to soften and moisturize dry, rough, and hyperkeratotic skin.

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

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.

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.

HOW SUPPLIED

Urea 41% Cream is supplied as:

8 oz (227 g) container

NDC: 85477-306-27

Dispensed by prescription.

About this document

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

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Drug information for Urea 41

Rx or OTC
Prescription (Rx)?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • Rx
Active ingredient Urea 41 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
41 mg/g – 227 g in 1 jar NDC 85477-306-27

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.