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
- 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
Harmonized identifier links#
Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
| Type | Scope | Identifier | Source field |
|---|---|---|---|
| spl id | 34dda0ad-a4e9-4d94-9ae0-180e24813be1 | id | |
| spl set id | 3fdf77d2-1b32-4d08-b9fa-07869988f5f0 | set_id |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
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#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
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.