FDA label 812c7e75-4c32-07f3-e053-2991aa0a43b1
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
- dc333304-b8e8-449e-87f5-2d692cbaa1dc
- SPL ID
- 812c7e75-4c32-07f3-e053-2991aa0a43b1
- Version
- 5
- Effective date
- 2019-02-05
- Source export date
- 2026-09-28
- Source partition
- 10
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0010-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/4bbc9760f647649b787710953d978bd6419e899ba8b90f32c3d972aae43947f8/drug-label-0010-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 06:11:53
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 | 812c7e75-4c32-07f3-e053-2991aa0a43b1 | id | |
| spl set id | dc333304-b8e8-449e-87f5-2d692cbaa1dc | set_id |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
V. WARNINGS A. 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. B. Test for skin sensitivity before using SunVanish 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 warm water and contact their physician. If no bleaching or lightening effect is noted after 2 months of treatment, SunVanish should be discontinued. SunVanish is formulated for use as a skin bleaching agent and should not be used for the prevention of sunburn. C. Sunscreen use is an essential aspect of hydroquinone therapy because even minimal sunlight exposure sustains melanocytic activity. The sunscreens in SunVanish provide the necessary sun protection during skin bleaching therapy. After clearing and during maintenance therapy, sun exposure should be avoided on bleached skin by application of a broad spectrum sunscreen greater than SPF 15 and protective clothing to prevent repigmentation. D. Keep this and all medication out of the reach of children. In case of accidental ingestion, call a physician or a poison control center immediately. E. WARNING: Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions (e.g. hives, itching, wheezing, anaphylaxis, severe asthma attack) in certain susceptible persons. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
VII. ADVERSE REACTIONS No systemic adverse reactions to hydroquinone have been reported. Occasional hypersensitivity (localized contact dermatitis) may occur in which case the medication should be discontinued and the physician notified immediately. Sensitivity to sodium metabisulfate is a potential. See WARNINGS .
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.