Hydroquinone
Other Dermatologicals
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- Drug class
- Other Dermatologicals
- Availability
- Prescription and OTC
- Routes
- Topical
- Markets covered
- 3
- Products on record
- 7
- FDA reports (12 mo)
- 58
Overview
Hydroquinone is an active pharmaceutical ingredient in the Other Dermatologicals group (D11AX). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.
Regulatory status by market
| Market | Regulator | Products | Last revision |
|---|---|---|---|
| US United States | FDA | 3 | October 23, 2025 |
| GB United Kingdom | MHRA | 3 | November 7, 2025 |
| CA Canada | Health Canada | 1 | March 22, 2025 |
USUnited States· FDA
3 products
Uses
Uses helps prevent sunburn If used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun
How to take
GBUnited Kingdom· MHRA
3 products
Uses
For Topical Administration For reducing hyperpigmentation of skin, such as persistent freckles and brown marks (lentigines) and irregular pigmentation of negroid skin.
How to take
CACanada· Health Canada
1 product
Uses
ERFA HYDROQUINONE is indicated for: the short-term treatment of hyperpigmented skin conditions such as chloasma, melasma, ‘liver spots’, ‘age spots’, freckles, senile/solar lentigines, and post- inflammatory hyperpigmentation. • UV protection (sunscreen, and/ or protective clothing) should be used.
See Warnings and Precautions. • If reduction of pigmentation is not observed within 8-12 weeks of treatment (3 weeks for melasma), therapy should be discontinued and the hyperpigmented skin assessed for potentially more serious conditions.
See Warnings and Precautions. • Hyperpigmented skin should be thoroughly assessed for malignant lesions. 1 Pediatrics Pediatrics (<18 years): No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use.
2 Geriatrics Geriatrics (≥65 years): No appropriate data are available to Health Canada; therefore, Health Canada has not authorized an indication for geriatric use.
Sources & citations
- [1]FDA DailyMed · 16efa2db-8172-40… · revised October 23, 2025 [PDF]
- [2]MHRA (UK) · PL492260023 · revised November 7, 2025
- [3]Health Canada (DPD) · 02491702 · revised March 22, 2025
- [4]OpenFDA adverse-event reports (US), 12 months ending June 4, 2026.
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.