FDA label 0ea0540b-782d-d622-e063-6394a90ace9d

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
9a1069df-db5d-4ffd-a2da-9137fb7dd4f3
SPL ID
0ea0540b-782d-d622-e063-6394a90ace9d
Version
4
Effective date
2024-01-10
Source export date
2026-10-12
Source partition
11
Source file
https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/a497e765d824a2e2aa9e88d5f0eea2aae9dcba363989e5f163395cda5c3c9dd8/drug-label-0011-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:39:02

Warnings cross-check#

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Warnings sections page 1 of 1 · 1 matching rows.

warnings

WARNINGS Hydroquinone is a skin bleaching agent which may produce undesired effects if not used as directed. The physician should be familiar with the contents of this insert before prescribing or dispensing this product. Avoid unnecessary sun exposure, use an effective broad-spectrum sunscreen agent or protective clothing should be worn to cover bleached skin to prevent re-pigmentation from occurring. Hydroquinone may produce exogenous ochronosis, a gradual blue-black darkening of the skin. If his condition occurs, discontinue treatment and consult your physician. Avoid contact with eyes and mucous membranes. Keep out of reach of children. In case of accidental ingestion, call a physician or a poison control center immediately.

Adverse reactions cross-check#

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

adverse reactions

Adverse Reactions The following reactions have been reported: dryness and fissuring of paranasal and infraorbital areas, erythema, and stinging. Occasional hypersensitivity (localized contact dermatitis) may develop. If this occurs, the medication should be discontinued, and the physician notified immediately.

Reported adverse events (FAERS/openFDA)#

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