Urea 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 40 Percent
- Generic name
- UREA
- Manufacturer
- Method Pharmaceuticals, LLC
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- d35b75e1-937d-ebc4-e053-2a95a90ac0d8
- SPL ID
- 4aad643a-b8f7-e2cb-e063-6394a90affec
- Version
- 8
- Effective date
- 2026-02-12
- Source export date
- 2026-09-28
- Source partition
- 11
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/aa96b5a2be6b394393acd0090f6948bdf99e0e8e00666f81608929c8fa83db77/drug-label-0011-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 06:19:01
| 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 Percent | openfda.brand_name | |
| generic name | UREA | openfda.generic_name | |
| manufacturer name | Method Pharmaceuticals, LLC | openfda.manufacturer_name | |
| ndc | package | 58657-487-01 | openfda.package_ndc |
| ndc | package | 58657-487-07 | openfda.package_ndc |
| ndc | package | 58657-487-03 | openfda.package_ndc |
| ndc | product | 58657-487 | openfda.product_ndc |
| ndc11 | package | 58657048703 | derived:openfda.package_ndc |
| ndc11 | package | 58657048707 | derived:openfda.package_ndc |
| ndc11 | package | 58657048701 | derived:openfda.package_ndc |
| rxcui | 198342 | openfda.rxcui | |
| spl id | 4aad643a-b8f7-e2cb-e063-6394a90affec | id | |
| spl set id | d35b75e1-937d-ebc4-e053-2a95a90ac0d8 | set_id | |
| unii | 8W8T17847W | openfda.unii |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
WARNINGS: FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. KEEP OUT OF REACH OF CHILDREN. Avoid contact with eyes, lips and mucous membranes. General: This product is to be used as directed by a physician and should not be used to treat any condition other than that for which it was prescribed. If redness or irritation occurs, discontinue use and consult a physician. Information for Patients: Patients should discontinue the use of this product if the condition becomes worse or if a rash develops in the area being treated or elsewhere. Avoid contact with eyes, lips and mucous membranes. Carcinogenesis, Mutagenesis and Impairment of Fertility: Long-term animal studies for carcinogenic potential have not been performed on this product to date. Studies on reproduction and fertility also have not been performed. Pregnancy: Category C . Animal reproduction studies have not been conducted with this product. It is also not known whether this product can affect reproduction capacity or cause fetal harm when administered to a pregnant woman. This product should be used by a pregnant woman only if clearly needed or when potential benefits outweigh potential hazards to the fetus. Nursing Mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when this product is administered to a nursing woman.
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.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.