FDA label 8b8f4397-c0f1-4022-b70a-5328bac54204

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
eef16915-e2cf-4483-9b99-9efcf012904a
SPL ID
8b8f4397-c0f1-4022-b70a-5328bac54204
Version
2
Effective date
2017-06-13
Source export date
2026-10-12
Source partition
1
Source file
https://download.open.fda.gov/drug/label/drug-label-0001-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/7928c8e8c6256620071a8b7e5b93eb8dfa543649c08d17a01ea02251012ba58c/drug-label-0001-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:25:48

Warnings cross-check#

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

Warnings sections page 1 of 1 · 3 matching rows.

warnings

Avoid contact with eyes, nose, mouth and lips. In case of accidental contact, patient should rinse thoroughly with water and contact a physician. Sunscreen use is an essential part of hydroquinone therapy because even minimal amounts of 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.

warnings

Avoid contact with eyes, nose, mouth and lips. In case of accidental contact, patient should rinse thoroughly with water and contact a physician. Sunscreen use is an essential aspect of hydroquinone therapy 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 asthamtic 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.

warnings

Warnings For external use only Do not use on damaged or broken skin Stop use and ask a doctor if rash occurs When using this product, keep out of eyes. Rinse with water to remove. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Reported adverse events (FAERS/openFDA)#

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