FDA label 1dfa28ee-9907-4ca4-ae1a-b2ee40990c34

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
ed382263-5346-4c0e-a652-3d9ed41d41cb
SPL ID
1dfa28ee-9907-4ca4-ae1a-b2ee40990c34
Version
3
Effective date
2017-06-13
Source export date
2026-10-12
Source partition
6
Source file
https://download.open.fda.gov/drug/label/drug-label-0006-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/b25dad4aaef9c88f0e827394a34fbbd1ce7d71422fa46b5d1e123befad498c1d/drug-label-0006-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:49:12

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 2 · 5 matching rows.

warnings

Warnings Avoid getting into eyes. For external use only. Keep out of reach of children.

warnings

Warnings Avoid getting into eyes. For external use only. Keep out of reach of children.

warnings

Warnings Avoid contact with eyes, nose, mouth, or lips. In case of accidental contact, patient should rinse eyes thoroughly with water and contact physician. Sunscreen use is an essential aspect of hydroquinone therapy because even minimal sunlight exposure sustains melanocytic activity.

warnings

Warning Avoid contact with eyes, nose, mouth and lips. in case of accidental contact, patient should rinse eyes thoroughly with water and contact physician. Sunscreen is an essential aspect of hydroquinone therpay because even minimal sunlight exposure sustains melanocytic activity. Contains sodium metabisulfite, a sulfite that may cause allergic - type reactions including anaphylactic symptoms and life- threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.

Reported adverse events (FAERS/openFDA)#

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