Hydro-Q

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)

Brand name
Hydro-Q
Generic name
HYDROQUINONE
Manufacturer
Dermavance Pharmaceuticals
Product type
HUMAN PRESCRIPTION DRUG
SPL set ID
486781be-498a-49b4-9a80-2dfd02f5e358
SPL ID
c8c85250-96ad-4bd8-9f74-a55737881fd3
Version
4
Effective date
2023-01-12
Source export date
2026-10-12
Source partition
9
Source file
https://download.open.fda.gov/drug/label/drug-label-0009-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/fb14b8f3d34b45230a84f851c029385f512adf3f002423a9b78d4f7ca626ecec/drug-label-0009-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:25:06
Harmonized routes table
Harmonized routes
TOPICAL

Warnings cross-check#

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Warnings sections page 1 of 1 · 1 matching rows.

warnings

WARNINGS CAUTION: Hydroquinone is a depigmenting agent that 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 HYDRO-Q ® by applying a small amount of the gel to an unbroken patch of skin and check within 24 hours. Minor redness is not a contraindication but where there is itching and vesicle 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 2 months of treatment the use of HYDRO-Q ® should be discontinued. HYDRO-Q ® is formulated for the treatment of dyschromia and should not be used for the prevention of sunburn. 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) or by use of protective clothing Keep this and all medications out of reach of children. In case of accidental ingestion, contact a physician or a poison control center immediately. WARNING: Contains sodium metabisulfite, a sulfite that may cause serious allergic reactions (e.g., hives, itching, wheezing, anaphylaxis, severe asthma attack) in certain susceptible persons On rare occasions, a gradual blue-black darkening of the skin may occur, in which case, use of HYDRO-Q ® 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.