FDA label 34dda0ad-a4e9-4d94-9ae0-180e24813be1

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
3fdf77d2-1b32-4d08-b9fa-07869988f5f0
SPL ID
34dda0ad-a4e9-4d94-9ae0-180e24813be1
Version
3
Effective date
2015-01-17
Source export date
2026-10-12
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/2026-10-12/13cbfcd236c665f0ee69e2d9141331148dcdff45d1679c92f029cfba27dd74a2/drug-label-0005-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:42:36

Warnings cross-check#

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Warnings sections page 1 of 1 · 1 matching rows.

warnings

Warning 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 skn sensitivity before using Aclaro PD (hydroquinone USP 4%) bioadhesive 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, vasicle 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 PD bioadhesive emulsion should be discontinued. C. Sunscreen use is an essential aspect of hydroquinone therapy because even minimal sunlight exposure sustains melanocyte activity. The suncreens in Aclro PD Bioadhesive emulsion provides the necessary sun protection during therapy. During and after the use of Aclaro PD bioadhesive 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 ingenstion, contact a physician or poison control center immediately. E. On rare occasions, a gradual blue-black darkening of the skim 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.