FDA Label for Urea 41%
View Indications, Usage & Precautions
Urea 41% Product Label
The following document was submitted to the FDA by the labeler of this product Oncora Pharma, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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
Urea 41% Cream 8 oz. (227 g): NDC 85477-905-30
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.
Urea 41% Cream™
Distributed by
Oncora Pharma
Dallas, TX 75161
* Please review the disclaimer below.
