Urea 41%

Product NDC
59088-489
11-digit product format
590880489
Labeler code
59088
Product ID
59088-489_da5d8eae-8d63-d354-e053-2995a90a7999
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Urea
Dosage form
CREAM
Route
TOPICAL
Labeler
PureTek Corporation
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2022-06-07
Substance
UREA
Active strength
410 mg/g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Urea 41%UREAPureTek Corporationda5d8eae-8d64-d354-e053-2995a90a79992022-06-07Warnings, Adverse reactionsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

WARNINGS FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. KEEP OUT OF REACH OF CHILDREN. Avoid contact with eyes, lips and mucous membranes. General This product is to be used as directed by a physician and should not be used to treat any condition other than that for which it was prescribed. If redness or irritation occurs, discontinue use and consult a physician. Information for Patients Patients should discontinue the use of this product if the condition becomes worse or if a rash develops in the area being treated or elsewhere. Avoid contact with eyes, lips and mucous membranes. Carcinogenesis, Mutagenesis and Impairment of Fertility: Long-term animal studies for carcinogenic potential have not been performed on this product to date. Studies on reproduction and fertility also have not been performed. Pregnancy: Category C . Animal reproduction studies have not been conducted with this product. It is also not known whether this product can affect reproduction capacity or cause fetal harm when administered to a pregnant woman. This product should be used by a pregnant woman only if clearly needed or when potential benefits outweigh potential hazards to the fetus. Nursing Mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when this product is administered to a nursing woman.

Adverse reactions cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

adverse reactions

ADVERSE REACTIONS: Transient stinging, burning, itching or irritation may occur and normally disappear upon discontinuing the medication.

Additional Listing Data#

Finished product
Yes
Brand name base
Urea 41%
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
UREA410 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8W8T17847W
Rxcui1436933

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59088-489-16Urea 41%227 g in 1 BOTTLECREAM2271

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59088-489-16GM - Gram59088-48922a1e7d7-5852-424e-8a1b-30fd54f4a45212022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59088-489UREA 41% (UREA) CREAM [PURETEK CORPORATION]1Current NDC, Legacy NDC, 1 package rows20220608_da5d8eae-8d64-d354-e053-2995a90a7999.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1436933urea 41 % Topical CreamPSNda5d8eae-8d64-d354-e053-2995a90a79991
1436933urea 410 MG/ML Topical CreamSCDda5d8eae-8d64-d354-e053-2995a90a79991
1436933urea 41 % Topical CreamSYda5d8eae-8d64-d354-e053-2995a90a79991

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59088-489-1659088048916227 g in 1 BOTTLE (59088-489-16) 227 g2022-06-070000-00-00NoNoCurrent