Urea 41% by Oncora Pharma, LLC UREA 41%- urea cream

Urea 41% by

Drug Labeling and Warnings

Urea 41% by is a Prescription medication manufactured, distributed, or labeled by Oncora Pharma, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

UREA 41% 
urea cream

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 85477-905
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
UREA (UNII: 8W8T17847W) (UREA - UNII:8W8T17847W)	UREA	410 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CETEARETH-20 (UNII: YRC528SWUY)
CETYL ALCOHOL (UNII: 936JST6JCN)
PARAFFIN (UNII: I9O0E3H2ZE)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
XANTHAN GUM (UNII: TTV12P4NEE)
POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
LAURETH-7 (UNII: Z95S6G8201)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85477-905-30	227 g in 1 BOTTLE; Type 0: Not a Combination Product	06/11/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		06/11/2025

Labeler - Oncora Pharma, LLC (119482542)