FDA label 5409ad5a-a055-4be6-881c-ea374f202dd4

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
62c05873-cdf8-4a4a-9744-e4dbe3e822ff
SPL ID
5409ad5a-a055-4be6-881c-ea374f202dd4
Version
3
Effective date
2016-05-23
Source export date
2026-10-12
Source partition
1
Source file
https://download.open.fda.gov/drug/label/drug-label-0001-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/7928c8e8c6256620071a8b7e5b93eb8dfa543649c08d17a01ea02251012ba58c/drug-label-0001-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:26:02

Warnings cross-check#

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Warnings sections page 1 of 1 · 1 matching rows.

warnings

Warnings A. Caution: Hydroquinone is a depigmenting 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. B.Test for skin sensitivity before using Aclaro® (hydroquinone USP 4%) emulsion 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, vesicle formation, or excessive inflammatory response, further treatment is not advised. Close patient supervision is recommended. Contact with the eyes should be avoided. If no lightening effect is noted after two months of treatment, use of Aclaro® emulsion should be discontinued. C. Sunscreen use is an essential aspect of hydroquinone therapy because even minimal sunlight exposure sustains melanocyte activity. The sunscreens in Aclaro® emulsion provide the necessary sun protection during therapy. During and after the use of Aclaro® emulsion, sun exposure should be limited or sun-protective clothing should be used to cover the treated areas to prevent repigmentation. D. Keep this and all medications out of the reach of children. In case of accidental ingestion, contact a physician or poison control center immediately. E. Contains sodium metabisulfite, a sulfite that may cause serious allergic reactions (e.g., hives, itching, wheezing, anaphylaxis, severe asthma attack) in certain susceptible persons. F. On rare occasions, a gradual blue-black darkening of the skin may occur. If this occurs, the product should be discontinued and a physician contacted immediately.

Adverse reactions cross-check#

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

adverse reactions

Adverse Reactions No systemic reactions have been reported. Occasional cutaneous 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.