FDA label 055355a2-6900-425d-8d8e-fd43af9e4218

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
fd5010a5-be5f-419d-a6d2-215ae2009da2
SPL ID
055355a2-6900-425d-8d8e-fd43af9e4218
Version
4
Effective date
2013-04-02
Source export date
2026-10-12
Source partition
12
Source file
https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/edd23646015c9adc800cdbe2b778398a2d2b70e90dce5721ef2b191499a0397f/drug-label-0012-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:49:24

Warnings cross-check#

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Warnings sections page 1 of 1 · 1 matching rows.

warnings

A CAUTION: Hydroqurone is a depigmenting agent that may produce unwanted cosmetic effects if not used as directed. The physician should be familar with the contents of this insert before prescribing or dispensing this medication.B. Test for skin sensitivity before using EpiQuin Micro 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 eves should be avoided. If no lightening effect is noted after two months of treatment, use of EpiQuin Micro should be discontinued. C.Sunscreen use is an essential aspect of hydroquinone therapy, because even minimal sunlight sustains melanocytic activity. To prevent repigmentation during treatment and maintenance therapy. sun exposure on treated skin should be avoided by application of a broad spectrum sunscreen (SPF 15 or greater) of by use of protective clothing. D. Keep this and aI medications out of reach of children. In case of accidental ingestion, contact a physician or a poison control center immediately. E. WARNING: Contains sodium metabisulfite,a sulfite that may cause serious allergic reactions (e.g., hives, itching, wheezing,anaphylaxis, severe asthma attack) in certain suscepllble persons.F. On rare occasions, a gradual blue-black darkening of the skin may occur, in which case, use of EpiQuin Micro 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 (Iocalized contact dermatitis) may occur, in which case the medication should be discontinued and physician notified immediately.

Reported adverse events (FAERS/openFDA)#

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