FDA label ebf0e8fb-7ff8-2a26-e053-2a95a90a1180

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
5c4ea0c9-6b61-4e2c-97cd-60fd9b46e47c
SPL ID
ebf0e8fb-7ff8-2a26-e053-2a95a90a1180
Version
3
Effective date
2022-10-26
Source export date
2026-09-28
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/2026-09-28/9839785a692b692224cd5f90f9e3a9514c9923a6f521ab83eed3bedc7c0e1d05/drug-label-0005-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:28:09

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

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. Test for skin sensitivity before using Hydroquinone Cream by applying asmall amount to an unbroken patch of skin and check in 24 hours. Minorredness is not a contraindication, but where there is itching or vesicleformation or excessive inflammatory response, further treatment is notadvised. Close patient supervision is recommended.Contact with the eyes should be avoided. In case of accidental contact, pa- tient should rinse eyes thoroughly with water and contact physician. A bitter taste and anesthetic effect may occur if applied to lips. Keep out of reach of children. If no bleaching or lightening effect is noted after 2 months oftreatment use, Hydroquinone Cream should be discontinued. This product isformulated for use as a skin bleaching agent and should not be used for the prevention of sunburn. Sunscreen use is an essential aspect of Hydroquinone therapy becauseeven minimal sunlight exposure sustains melanocytic activity. After clear-ing and during maintenance therapy, sun exposure should be avoided on bleached skin by application of a sunscreen or sunblock agent, or protective clothing to prevent repigmentation. There are no sunblocking or sunscreening agents in COMPLEX HQ+ and since minimal sunlight exposure may reverse the bleaching effect of this preparation, it should be used only at night or on areas of the body covered by protective clothing. During the daytime, sunblocking or broad spectrum sunscreen preparations or protective clothing should be used to prevent the bleached areas from repigmentation. Keep this and all medications out of the reach of children. In case of ac-cidental ingestion, call a physician or a poison control center immediately. Warning: Contains sodium metabisulfite, a sulfite that may cause serious allergic type reactions (e.g. hives, itching, wheezing, anaphylaxis, severe asthma attacks) in certain susceptible persons.

Reported adverse events (FAERS/openFDA)#

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