FDA label bb0c2006-4184-4a86-bb19-e19a4325a3af

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
f9d3f466-12db-433d-9a25-751624041b68
SPL ID
bb0c2006-4184-4a86-bb19-e19a4325a3af
Version
3
Effective date
2014-10-11
Source export date
2026-08-17
Source partition
5
Source file
https://download.open.fda.gov/drug/label/drug-label-0005-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-08-17/28baf16af715ee15453297f68cf3645a4d0fd0920220426fbe9d0c3d228bd86d/drug-label-0005-of-0014.json.zip
Source manifest SHA-256
ca19d5b1416b6b66a9d383bfdc77d90e91adfeefe16ffcc1ac6b06ceb90d8d73
Import run
20260818T065550Z
Imported at
2026-08-18 07:21:09

Warnings cross-check#

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Warnings sections page 1 of 1 · 1 matching rows.

warnings

Hydroquinone is a skin - bleaching agent, which may produce unwanted cosmetic effects if not used as directed. The physician should be familiar with the contents of this insert before prescribing or dispensing this product. Test for skin sensitivity before using by applying a small amount to an unbroken patch of skin and check within 24 hours. Minor redness is not a contraindication, but where there is itching or vesicle formation or excessive inflammatory response, product should be discontinued and physician consulted. Close patient supervision is recommended. Warnings: Avoid contact with eyes, nose, mouth, and lips. In case of accidental contact, patient should rinse thoroughly with water and contact a physician. Sunscreen use is an essential aspect of hydroquinone therapy because even minimal sunlight exposure sustains melanocytic activity. Contains sodium metabusulfite, a sulfite that may cause allergic - type reactions including anaphylactic symptoms and life - threatening or elss severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in te general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people

Adverse reactions cross-check#

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

adverse reactions

No systemic adverse reactions ahve been reported. Occasional hypersensitivity (localized contact dermatitis) may occur, in which case the product should be discontinues and the physician notified immediately.