FDA label a26c966e-7124-4e45-b87d-2bd5d777e9b4

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
6bfcc6a9-899b-4ad7-b4e8-67d95fd04708
SPL ID
a26c966e-7124-4e45-b87d-2bd5d777e9b4
Version
2
Effective date
2017-11-29
Source export date
2026-10-12
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/2026-10-12/befa34274042a52f589b22fe2add0b1c6f0a385c96447c28303de164bb144af5/drug-label-0010-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:32:35

Warnings cross-check#

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Warnings sections page 1 of 1 · 1 matching rows.

warnings

WARNINGS 1. 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 medication. 2. To evaluate possible susceptibility to irritation or sensitivity, each patient should begin by applying the medication to a small portion of unbroken skin at or near the pigmented area over a period of several days. Minor redness is not necessarily a contraindication, but treatment should be discontinued if itching, excessive inflammation or vesicle formation occurs. Use of MELQUIN-3 ® TOPICAL SOLUTION in paranasal and infraorbital areas increases the chance of irritations (See ADVERSE REACTIONS ). If no improvement is seen after two months of treatment, use of this product should be discontinued. 3. There are no sunblocking or sunscreening agents in MELQUIN-3 ® TOPICAL SOLUTION . Sun exposure should be minimized by using a sunscreen agent, or protective clothing to cover bleached skin in order to prevent repigmentation from occuring. For daytime treatment use NUQUIN HP 4% CREAM, NUQUIN HP 4% GEL or MELPAQUE HP 4% CREAM. 4. Keep this and all other medications out of reach of children. In case of accidental ingestion, call a physician or a poison control center immediately. 5. Avoid contact with eyes. In case of accidental contact, patient should rinse eyes thoroughly with water and contact physician. A bitter taste and anesthetic effect may occur if applied to the lips.

Adverse reactions cross-check#

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

adverse reactions

ADVERSE REACTIONS No systemic adverse reactions have been reported. Occasional hypersensitivity (localized contact dermatitis) may occur in which case 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.