Urea 41 by Oncora Pharma, LLC UREA 41 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]

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.

PRINCIPAL DISPLAY PANEL

Urea Cream 41%

For dry, rough, cracked, and callused skin.

For external use only. Not for ophthalmic use.

8 oz (227 g)

Distributed by:
Oncora Pharma
Dallas, TX 75161

pdp

INGREDIENTS AND APPEARANCE

UREA 41 
urea 41 cream

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 85477-306
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
UREA (UNII: 8W8T17847W) (UREA - UNII:8W8T17847W)	UREA	41 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CETEARYL ALCOHOL (UNII: 2DMT128M1S)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CETEARETH-20 (UNII: YRC528SWUY)
PARAFFIN (UNII: I9O0E3H2ZE)
POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)
XANTHAN GUM (UNII: TTV12P4NEE)
LAURETH-7 (UNII: Z95S6G8201)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85477-306-27	227 g in 1 JAR; Type 0: Not a Combination Product	03/06/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		03/06/2026

Labeler - Oncora Pharma, LLC (119482542)