Evara 40.5% cream

Manufacturer
Oncora Pharma, LLC
Effective date
2026-05-01
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:17:34

Label at a glance#

ProductEvara
Active ingredientUREA
Label structure8 sections

Dosage and administration

Apply Evara 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.

Label contents#

Full prescribing information#

INDICATIONS & USAGE

INDICATIONS & USAGE SECTION

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

CONTRAINDICATIONS SECTION

This product is contraindicated in persons with known or suspected hypersensitivity to any of the ingredients of the product.

WARNINGS

WARNINGS SECTION

Avoid contact with eyes, lips and mucous membranes.

ADVERSE REACTIONS:

ADVERSE REACTIONS SECTION

Discontinue use and consult a physician if redness or irritation occurs.

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

Apply Evara 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

HOW SUPPLIED SECTION

Evara Urea 40.5% Cream 8 oz. (227 g): NDC 85477-308-08

STORAGE

SAFE HANDLING WARNING SECTION

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.

Evara

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

pdp
pdp

Distributed by

Oncora Pharma

Dallas, TX 75228

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2741686urea 40.5 % Topical CreamPSN2
2741686urea 405 MG/ML Topical CreamSCD2
2741686urea 40.5 % Topical CreamSY2

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130854770308084GTIN-13: 0854770308084
EAN-13: 0854770308084
GTIN-12: 854770308084
UPC-A: 854770308084
GTIN storage (14 digits): 00854770308084
evara-1.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85477-308-08Evara227 g in 1 BOTTLECREAM2272

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85477-30885477-308-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 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
EvaraUREA 40.5 CREAMOncora Pharma, LLC098d85ca-7f48-45a1-80ed-4d57936842b92026-05-01Warnings, Adverse reactionsExact identifier
ndc (package): 85477-308-08
ndc (product): 85477-308
ndc11 (package): 85477030808
spl id: 3fc2bb16-70ef-41f8-9a6a-a6a42bf58e5f
spl set id: 098d85ca-7f48-45a1-80ed-4d57936842b9

Reported adverse events (FAERS/openFDA)#

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