warnings
Warnings For topical use only. Avoid contact with eyes, lips or mucous membranes.
Urea Cream 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 Cream 40%
- Generic name
- UREA
- Manufacturer
- Laser Pharmaceuticals, LLC
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- ef2db58d-e760-417d-8574-45a411c49b47
- SPL ID
- 42f70c2c-33ab-99df-e063-6394a90a5f86
- Version
- 13
- Effective date
- 2025-11-06
- 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 05:25:26
| 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 Cream 40% | openfda.brand_name | |
| generic name | UREA | openfda.generic_name | |
| manufacturer name | Laser Pharmaceuticals, LLC | openfda.manufacturer_name | |
| ndc | package | 16477-340-01 | openfda.package_ndc |
| ndc | package | 16477-340-07 | openfda.package_ndc |
| ndc | package | 16477-340-03 | openfda.package_ndc |
| ndc | product | 16477-340 | openfda.product_ndc |
| ndc11 | package | 16477034003 | derived:openfda.package_ndc |
| ndc11 | package | 16477034001 | derived:openfda.package_ndc |
| ndc11 | package | 16477034007 | derived:openfda.package_ndc |
| rxcui | 198342 | openfda.rxcui | |
| spl id | 42f70c2c-33ab-99df-e063-6394a90a5f86 | id | |
| spl set id | ef2db58d-e760-417d-8574-45a411c49b47 | set_id | |
| unii | 8W8T17847W | openfda.unii |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
warnings and cautions
Urea Cream 40% Rx Only For external use only. Not for ophthalmic use.
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.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.