The following Structured Product Label (SPL) was submitted to the FDA by Blue Heron Pharmaceuticals, Llc for the product Urevia 10 (NDC 85622-600). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding indications & usage:, contraindications:, warnings:, dosage and administration:, storage:, adverse reactions:, how supplied:, label:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
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.
This product is contraindicated in persons with known or suspected hypersensitivity to any of the ingredients of the product.
Keep out of the reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
Apply Urea 10% Lotion to affected area(s) twice per day, or as directed by your physician. Rub in until completely absorbed.
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from freezing and excessive heat.
Discontinue use and consult a physician if redness or irritation occurs.
Urevia 10% Lotion
85622-0600-04
4 fl oz (118 mL)
Manufactured For:
Blue Heron Pharma
New Port Richey, FL 34652
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