warnings
Warnings For topical use only. Avoid contact with eyes, lips or mucous membranes. KEEP OUT OF REACH OF CHILDREN.
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
- Akron Pharma Inc.
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- 0ce643e9-cf13-4b51-8ffd-8d5636d73e51
- SPL ID
- 6153c0bc-1246-4396-a26d-cd066b909ef5
- Version
- 3
- Effective date
- 2024-09-25
- Source export date
- 2026-11-06
- 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/2026-11-06/39f3c0903357a80632a5484c9d6a804272f4b297080aa9c5a01a84db133f7a03/drug-label-0012-of-0014.json.zip
- Source manifest SHA-256
- 4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
- Import run
- 20261108T063105Z
- Imported at
- 2026-11-08 08:01:53
| 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 | Akron Pharma Inc. | openfda.manufacturer_name | |
| ndc | package | 71399-8456-1 | openfda.package_ndc |
| ndc | package | 71399-8456-3 | openfda.package_ndc |
| ndc | package | 71399-8456-7 | openfda.package_ndc |
| ndc | product | 71399-8456 | openfda.product_ndc |
| ndc11 | package | 71399845601 | derived:openfda.package_ndc |
| ndc11 | package | 71399845607 | derived:openfda.package_ndc |
| ndc11 | package | 71399845603 | derived:openfda.package_ndc |
| rxcui | 198342 | openfda.rxcui | |
| spl id | 6153c0bc-1246-4396-a26d-cd066b909ef5 | id | |
| spl set id | 0ce643e9-cf13-4b51-8ffd-8d5636d73e51 | 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
Adverse Reactions Transient stinging, burning, itching or irritation may occur and normally disappear upon discontinuing the medication. To report a serious adverse event or obtain product information, call 1-877-255-6999.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.