FDA.reportPublic FDA data

FDA label d24232ae-4862-6455-e053-2a95a90a9e4d

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
e66eb094-06e0-4cf8-96eb-a5a633498f1c
SPL ID
d24232ae-4862-6455-e053-2a95a90a9e4d
Version
2
Effective date
2021-12-03
Source export date
2026-09-28
Source partition
2
Source file
https://download.open.fda.gov/drug/label/drug-label-0002-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/f7d2b6e3f8600cd856280ab55a9c6fa54a642647191d164f9d1110e89f3f4097/drug-label-0002-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:17:17

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 For external use only When using this product avoid direct contact with eyes some users of this product may experience a mild skin irritation if skin irritation becomes severe, stop use and consult a physician do not use on children under 12 years of age unless directed by a physician sun exspoure should be limited by using a sunscreen agent, a sun blocking agent, or protective clothing to cover bleached skin when using and after using this product in order to prevent darkening from reoccurring avoid overuse of hydroquinone which has been associated with a rare skin condition called ochronosis​​

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.