warnings
Warnings For topical use only. Avoid contact with eyes, lips or mucous membranes.
Urea Cream 40 Percent
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 Percent
- Generic name
- UREA
- Manufacturer
- Method Pharmaceuticals, LLC
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- 0920f780-b504-1fea-e063-6394a90ae5a9
- SPL ID
- 49ee2dc0-c081-673b-e063-6294a90aa6c6
- Version
- 5
- Effective date
- 2026-01-15
- 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 06:27:04
| 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 Percent | openfda.brand_name | |
| generic name | UREA | openfda.generic_name | |
| manufacturer name | Method Pharmaceuticals, LLC | openfda.manufacturer_name | |
| ndc | package | 58657-489-03 | openfda.package_ndc |
| ndc | package | 58657-489-07 | openfda.package_ndc |
| ndc | package | 58657-489-01 | openfda.package_ndc |
| ndc | product | 58657-489 | openfda.product_ndc |
| ndc11 | package | 58657048903 | derived:openfda.package_ndc |
| ndc11 | package | 58657048901 | derived:openfda.package_ndc |
| ndc11 | package | 58657048907 | derived:openfda.package_ndc |
| rxcui | 198342 | openfda.rxcui | |
| spl id | 49ee2dc0-c081-673b-e063-6294a90aa6c6 | id | |
| spl set id | 0920f780-b504-1fea-e063-6394a90ae5a9 | 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 use of this product. To report SUSPECTED ADVERSE REACTIONS, contact Method Pharmaceuticals, LLC at 1-877-250-3427; or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.