FDA label 812d78ea-a14e-e3a2-e053-2a91aa0a6ff5

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
f1fd0340-7975-435f-9de8-3064c6e2250e
SPL ID
812d78ea-a14e-e3a2-e053-2a91aa0a6ff5
Version
8
Effective date
2019-02-05
Source export date
2026-08-01
Source partition
10
Source file
https://download.open.fda.gov/drug/label/drug-label-0010-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-08-01/928e480b2a9ec5fd356ebc3e5dcca70f0f57b8a051cfbb174a4421de39bb77a2/drug-label-0010-of-0014.json.zip
Source manifest SHA-256
bdd1454d0606b622b70458a306b8a10d8a8787db06fd9f46e69c7f7a4524b630
Import run
20260801T225920Z
Imported at
2026-08-01 23:25:53

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. There are no sunscreen agents in Glytone Skin Lightening Cream. 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 metabisulfite is a potential. See WARNINGS .