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
- 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 |
|---|
| TOPICAL |
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 |
|---|---|---|---|
| brand name | Hydro-Q | openfda.brand_name | |
| generic name | HYDROQUINONE | openfda.generic_name | |
| manufacturer name | Dermavance Pharmaceuticals | openfda.manufacturer_name | |
| ndc | package | 30815-0040-1 | openfda.package_ndc |
| ndc | product | 30815-0040 | openfda.product_ndc |
| ndc11 | package | 30815004001 | derived:openfda.package_ndc |
| rxcui | 310926 | openfda.rxcui | |
| spl id | c8c85250-96ad-4bd8-9f74-a55737881fd3 | id | |
| spl set id | 486781be-498a-49b4-9a80-2dfd02f5e358 | set_id | |
| unii | XV74C1N1AE | openfda.unii |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
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#
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.