FDA label a5f13ce4-dfb2-5565-e053-2a95a90a50dc

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
defcd89b-c608-4157-a940-7606d9eb26ae
SPL ID
a5f13ce4-dfb2-5565-e053-2a95a90a50dc
Version
3
Effective date
2020-05-18
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 05:16:11

Warnings cross-check#

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Warnings sections page 1 of 1 · 1 matching rows.

warnings

V. WARNINGS A. Contains sodium bisulfite, 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. There are no sunscreen agents in Glytone Skin Lightening Gel. Since minimal sunlight exposure may reverse the lightening effect of this preparation, an effective broad spectrum sunscreen should be used during the day, and unnecessary sun exposure avoided, or sun-protective clothing should be worn to cover treated areas in order to prevent repigmentation from occurring. For daytime lightening of unwanted hyperpigmented areas, Glytone SunVanish Skin Lightening Cream Broad Spectrum SPF 25 should be considered.

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 bisulfite is a potential. See WARNINGS .

Reported adverse events (FAERS/openFDA)#

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