UREA

Product NDC
24470-939
11-digit product format
244700939
Labeler code
24470
Product ID
24470-939_0fa43016-708e-c2e2-e063-6394a90ab5de
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
UREA
Dosage form
CREAM
Route
TOPICAL
Labeler
Cintex Services, LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2024-01-23
Substance
UREA
Active strength
400 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
UREAUREACintex Services, LLC0fa4445e-554c-c791-e063-6294a90a97132024-01-23Warnings, Adverse reactionsExact identifier

Warnings cross-check#

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

warnings and cautions

WARNINGS: KEEP OUT OF REACH OF CHILDREN. PRECAUTIONS: FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. 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 use of this product.

Additional Listing Data#

Finished product
Yes
Brand name base
UREA
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
UREA400 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8W8T17847W
Rxcui198342

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
24470-939-01UREA28.35 g in 1 BOTTLE, PLASTICCREAM28.351
24470-939-01UREA1 in 1 CARTONCREAM11
24470-939-03UREA85 g in 1 BOTTLE, PLASTICCREAM851
24470-939-07UREA198.4 g in 1 BOTTLE, PLASTICCREAM198.41

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
24470-939-01GM - Gram24470-9392a136667-6a8d-4141-a357-7cc6287d13b312024-03-12
24470-939-03GM - Gram24470-9390d3d3e19-d217-4035-9498-a082f6af722e12024-03-12
24470-939-07GM - Gram24470-939431b6ac4-2f6c-4928-93f1-e80aa9338e6112024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24470-939UREA CREAM [CINTEX SERVICES, LLC]1Current NDC, 4 package rows20240124_0fa4445e-554c-c791-e063-6294a90a9713.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198342urea 40 % Topical CreamPSN0fa4445e-554c-c791-e063-6294a90a97131
198342urea 400 MG/ML Topical CreamSCD0fa4445e-554c-c791-e063-6294a90a97131
198342urea 40 % Topical CreamSY0fa4445e-554c-c791-e063-6294a90a97131

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
24470-939-01244700939011 BOTTLE, PLASTIC in 1 CARTON (24470-939-01) / 28.35 g in 1 BOTTLE, PLASTIC2024-01-23NoNoCurrent
24470-939-032447009390385 g in 1 BOTTLE, PLASTIC (24470-939-03) 85 g2024-01-23NoNoCurrent
24470-939-0724470093907198.4 g in 1 BOTTLE, PLASTIC (24470-939-07) 198.4 g2024-01-23NoNoCurrent