FDA label a5f17279-5e4f-8c28-e053-2a95a90a6691

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
9b3d564a-de28-4a92-87f0-0ea750e3bfa5
SPL ID
a5f17279-5e4f-8c28-e053-2a95a90a6691
Version
3
Effective date
2020-05-18
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 01:34:50

Warnings cross-check#

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Warnings sections page 1 of 1 · 1 matching rows.

warnings

V. WARNINGS A. Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions (e.g. hives, itching, wheezing, anaphylaxis, severe asthma attack) in certain susceptible persons. 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. B. May produce exogenous ochronosis, a gradual blue-black darkening of the skin, the occurrence of which should prompt discontinuation of treatment. C. Sunscreen use is an essential aspect of hydroquinone therapy because minimal sunlight sustains melanocytic activity. The sunscreen agents in Glytone SunVanish provide sun protection during skin lightening therapy. During the day, supplement therapy by using an effective broad spectrum sunscreen and avoiding unnecessary sun exposure, or wear sun-protective clothing to cover treated areas in order to prevent repigmentation from occurring.

Adverse reactions cross-check#

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Adverse reactions sections page 1 of 1 · 1 matching rows.

adverse reactions

VII. ADVERSE REACTIONS No systemic adverse reactions to hydroquinone have been reported. Occasional hypersensitivity (localized contact dermatitis) may occur in which case the medication should be discontinued and the physician notified immediately. Sensitivity to sodium metabisulfite is a potential. See WARNINGS.

Reported adverse events (FAERS/openFDA)#

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