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Urevia 10 (Umecta) Package Insert

Status:
Prescription (Rx) Facts
Strength:
100 mg/mL
Brand names:
Active ingredient:

Prescribing information (package insert) - Urevia 10

Indications & Usage:

Usage: Intensely exfolitating and skin-softening cream with Urea 39%. Helps smooth and soften very, dry, rough, and thickened skin. Suitable for targeted application on areas with very dry, hardened or thick skin, rough patches and calluses, uneven, scaly, or flaky skin texture and thickened nail surface appearance. Helps soften and improve the cosmetic appearance of thickened or irregular nails.

Contraindications:

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

Warnings:

Keep out of the reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Dosage and Administration:

Apply Urea 10% Lotion to affected area(s) twice per day, or as directed by your physician. Rub in until completely absorbed.

Storage:

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from freezing and excessive heat.

Adverse Reactions:

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

How Supplied:

Urevia 10% Lotion

85622-0600-04

4 fl oz (118 mL)

Manufactured For:

Blue Heron Pharma

New Port Richey, FL 34652

About this document

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

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Drug information for Urevia 10

Rx or OTC
Prescription (Rx)?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • Rx
Active ingredient Urea 100 mg/mL
Dosage form Lotion
Route Topical
Marketing status not in the current FDA NDC Directory
Company (applicant) Blue Heron Pharmaceuticals, LLC
FDA approval UNAPPROVED DRUG OTHERUnapproved drug
Manufacturers 1 labelers list this drug on DailyMed
Packages (NDC)
Package
100 mg/mL – 118 ml in 1 jar / 1 in 1 jar NDC 85622-600-04

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.