Home FDA labels 41e367e1-3f71-43f9-8fa2-5ab8e1e36110 FDA label 41e367e1-3f71-43f9-8fa2-5ab8e1e36110 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 (canonical bytes are SHA-256 checked before publication)
SPL set ID 3856cdef-6be3-496f-afb9-a2e40b1abd08
SPL ID 41e367e1-3f71-43f9-8fa2-5ab8e1e36110
Version 7
Effective date 2024-05-21
Source export date 2026-10-12
Source partition 3
Source file https://download.open.fda.gov/drug/label/drug-label-0003-of-0014.json.zip
Source object key raw/openfda/drug-label/2026-10-12/f40eac55ff4c5d55c3d8bbc5766ea7e21e4196960cfb4703b96a406b491c0cd5/drug-label-0003-of-0014.json.zip
Source manifest SHA-256 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run 20261013T011858Z
Imported at 2026-10-13 01:31:14 Harmonized identifier links# Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
Harmonized identifiers page 1 of 1 · 2 matching rows.
Warnings cross-check# openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Warnings sections page 1 of 1 · 1 matching rows.
warnings WARNINGS Urea 35% Hydrating Topical 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. Urea 35% Hydrating Topical 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 sections page 1 of 1 · 1 matching rows.
adverse reactions ADVERSE REACTIONS Transient stinging, burning, itching or irritation is possible.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.