warnings
WARNINGS SECTION Caution: Discontinue use and consult a physician if redness or Irritation occurs. When using this product avoid contact with eyes, lips or mucous membranes.
Urea 40
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 40
- Generic name
- UREA
- Manufacturer
- Krewe Pharma, LLC
- Product type
- HUMAN OTC DRUG
- SPL set ID
- 415c4efd-95bd-4276-900c-e9da70266cd4
- SPL ID
- 74f07bb6-27de-49ad-bfc6-5ea8074e57af
- Version
- 1
- Effective date
- 2026-06-02
- Source export date
- 2026-09-28
- Source partition
- 4
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/c7ca0b7091cdaeab3f27713a6eef00adcf8fe722383633ddce61531b4c840544/drug-label-0004-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 05:26:20
| 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 40 | openfda.brand_name | |
| generic name | UREA | openfda.generic_name | |
| manufacturer name | Krewe Pharma, LLC | openfda.manufacturer_name | |
| ndc | package | 87021-603-04 | openfda.package_ndc |
| ndc | product | 87021-603 | openfda.product_ndc |
| ndc11 | package | 87021060304 | derived:openfda.package_ndc |
| rxcui | 198342 | openfda.rxcui | |
| spl id | 74f07bb6-27de-49ad-bfc6-5ea8074e57af | id | |
| spl set id | 415c4efd-95bd-4276-900c-e9da70266cd4 | set_id | |
| unii | 8W8T17847W | openfda.unii |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.