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Hydroquinone is a skin depigmenting ingredient also called 1,4-dihydroxybenzene. It has been used topically for hyperpigmented skin conditions such as melasma, freckles, lentigines, and other areas of excess melanin. Current single-ingredient hydroquinone 4 percent prescription labels on DailyMed can carry an unapproved drug status.
read more about hydroquinone ...Topical hydroquinone inhibits enzymatic oxidation of tyrosine to dopa and suppresses other melanocyte metabolic processes. This produces reversible depigmentation of treated skin. Sunlight and ultraviolet exposure can stimulate repigmentation.
FDA states that skin-lightening products containing hydroquinone are not approved for over-the-counter sale in the United States. Prescription hydroquinone skin products can still be obtained through healthcare professionals, but current single-ingredient 4 percent products listed on DailyMed can be marketed as unapproved drugs rather than FDA-approved drug products.
Current prescription hydroquinone 4 percent labeling describes application to affected hyperpigmented areas twice daily, in the morning and before bedtime. Treatment stops if no improvement is seen after two months. Sunscreen and reduced ultraviolet exposure are used to limit repigmentation.
Hydroquinone can cause irritation, redness, stinging, contact dermatitis, and exogenous ochronosis with blue-black skin darkening. FDA has also received reports of facial swelling and serious skin reactions. Safety in pregnancy and in children age 12 and younger has not been established in current 4 percent labeling.
Topical hydroquinone has been used to lighten areas of excess skin pigmentation such as melasma, freckles, and lentigines.
No. FDA states that hydroquinone skin-lightening products are not approved for over-the-counter sale.
Yes. Exogenous ochronosis is a recognized adverse effect that causes gradual blue-black darkening of treated skin.
Ultraviolet exposure can stimulate repigmentation of treated areas.
DailyMed - HYDROQUINONE 4% cream. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ba2b7504-17bb-4b9e-8db1-937f83d75a03. Date Accessed October 1, 2026.
FDA Warns Consumers of Skin Products Containing Mercury and/or Hydroquinone. U.S. Food and Drug Administration. https://www.fda.gov/consumers/health-fraud-scams/fda-warns-consumers-skin-products-containing-mercury-andor-hydroquinone. Date Accessed October 1, 2026.
Hydroquinone. Drugs and Lactation Database (LactMed). https://www.ncbi.nlm.nih.gov/books/NBK500669/. Date Accessed October 1, 2026.
Hydroquinone. PubChem. https://pubchem.ncbi.nlm.nih.gov/compound/Hydroquinone. Date Accessed October 1, 2026.
Hydroquinone. StatPearls. https://www.ncbi.nlm.nih.gov/books/NBK539693/. Date Accessed October 1, 2026.