FDA label c7772272-e9c8-4fad-ae20-1fe955afa802
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
- SPL set ID
- 894b8b98-0f8f-44bd-ac6a-584e3b30d157
- SPL ID
- c7772272-e9c8-4fad-ae20-1fe955afa802
- Version
- 5
- Effective date
- 2011-03-16
- Source export date
- 2026-09-28
- Source partition
- 5
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0005-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/9839785a692b692224cd5f90f9e3a9514c9923a6f521ab83eed3bedc7c0e1d05/drug-label-0005-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 05:29:05
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 |
|---|---|---|---|
| spl id | c7772272-e9c8-4fad-ae20-1fe955afa802 | id | |
| spl set id | 894b8b98-0f8f-44bd-ac6a-584e3b30d157 | set_id |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
WARNINGS U40 Foam is for external use only. It is not for ophthalmic, oral, anal or intravaginal use. Contact with eyes, lips and all mucous membranes should be avoided. U40 Foam should not be used by persons who have a known hypersensitivity to urea or any of the other listed ingredients.
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 is possible. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.