warnings
5 WARNINGS For External Use Only • Avoid Contact With Eyes and Mouth • Keep Out of Reach of Children Store at 25º C (77º F); exclusions permitted to 15º to 30ºC (59º to 86º F). See USP Controlled Room Temperature
FDA label ea3b3d7c-ca55-260b-e053-2995a90a7624
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
- dd7806d9-50cf-486b-97ce-afeaef02d699
- SPL ID
- ea3b3d7c-ca55-260b-e053-2995a90a7624
- Version
- 5
- Effective date
- 2022-10-04
- 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 06:19:51
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 | ea3b3d7c-ca55-260b-e053-2995a90a7624 | id | |
| spl set id | dd7806d9-50cf-486b-97ce-afeaef02d699 | set_id |
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
6 ADVERSE REACTIONS Prophylaxis and Treatment of Gout Flares: The most commonly reported adverse reaction in clinical trials for the prophylaxis and treatment of gout was mild skin irritation at the site of application.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.