FDA label 5a4e3679-60da-4c02-b325-5b7aafafb375

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
5d843214-4ede-4bd5-a919-c8faca9ccade
SPL ID
5a4e3679-60da-4c02-b325-5b7aafafb375
Version
1
Effective date
2012-05-10
Source export date
2026-09-28
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/2026-09-28/9839785a692b692224cd5f90f9e3a9514c9923a6f521ab83eed3bedc7c0e1d05/drug-label-0005-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:29:48

Warnings cross-check#

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Warnings sections page 1 of 1 · 1 matching rows.

warnings

WARNINGS Caution 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 medication. Test for skin sensitivity before using by applying a small amount to an unbroken patch of skin and check in 24 hours. Minor redness is not a contraindication, but where there is itching or vesicle formation or excessive inflammatory response, further treatment is not advised. Close patient supervision is recommended. 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 lips. Sunscreen use is an essential aspect of hydroquinone therapy because even minimal sunlight exposure sustains melanocytic activity. Warning Contains sodium metabisulfite, a sulfite that may cause serious allergic type reactions (e.g., hives, itching, wheezing, anaphylaxis, severe asthma attacks) in certain susceptible persons.

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.