Urea 41

Manufacturer
Oncora Pharma, LLC
Effective date
2026-03-06
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:08:54

Label at a glance#

ProductUrea 41
Active ingredientUREA
Label structure6 sections

Indications and uses

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 ...

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.

Label contents#

Full prescribing information#

DESCRIPTION

DESCRIPTION SECTION

Urea 41% Cream used to soften and moisturize dry, rough, and hyperkeratotic skin.

INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

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

DOSAGE & ADMINISTRATION SECTION

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

HOW SUPPLIED SECTION

Urea 41% Cream is supplied as:

8 oz (227 g) container

NDC: 85477-306-27

Dispensed by prescription.

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.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
pdp

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130854770306271GTIN-13: 0854770306271
EAN-13: 0854770306271
GTIN-12: 854770306271
UPC-A: 854770306271
GTIN storage (14 digits): 00854770306271
urea-41-1.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85477-306-27Urea 41227 g in 1 JARCREAM2271

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
85477-306-27GM - Gram85477-306b193e121-68fe-4b5e-bde3-ce4e8b1564d512026-04-20

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85477-30685477-306-27

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Urea 41UREA 41Oncora Pharma, LLCff306984-a52b-48d8-88a8-3a4c72109e632026-03-06WarningsExact identifier
ndc (package): 85477-306-27
ndc (product): 85477-306
ndc11 (package): 85477030627
spl id: b128343f-a2d2-416d-b349-d5e39bdc3671
spl set id: ff306984-a52b-48d8-88a8-3a4c72109e63

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.