warnings
KEEP OUT OF REACH OF CHILDREN.
Urea 39% Cream
openFDA label record#
This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.
Verified complete openFDA source JSON
- Brand name
- Urea 39% Cream
- Generic name
- UREA 39% CREAM
- Manufacturer
- BioComp Pharma, Inc.
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- e79004b9-ffbc-3d06-e053-2995a90a8cd7
- SPL ID
- 4846ec49-3653-db3d-e063-6294a90aa815
- Version
- 3
- Effective date
- 2026-01-13
- Source export date
- 2026-09-28
- Source partition
- 12
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/663999d0fe1757c1e2cd13a4799d76d875f663e0bc57701092264ebe7febfc18/drug-label-0012-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 06:26:57
| Harmonized routes |
|---|
| TOPICAL |
Harmonized identifier links#
Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
| Type | Scope | Identifier | Source field |
|---|---|---|---|
| brand name | Urea 39% Cream | openfda.brand_name | |
| generic name | UREA 39% CREAM | openfda.generic_name | |
| manufacturer name | BioComp Pharma, Inc. | openfda.manufacturer_name | |
| ndc | package | 44523-801-08 | openfda.package_ndc |
| ndc | product | 44523-801 | openfda.product_ndc |
| ndc11 | package | 44523080108 | derived:openfda.package_ndc |
| rxcui | 1093289 | openfda.rxcui | |
| spl id | 4846ec49-3653-db3d-e063-6294a90aa815 | id | |
| spl set id | e79004b9-ffbc-3d06-e053-2995a90a8cd7 | set_id | |
| unii | 8W8T17847W | openfda.unii |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
Transient stinging, burning, itching or irritation may occur and normally disappear upon discontinuing the use of this product.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.