Hydroquinone: uses, strength, evidence, and side effects

At a glance

U.S. status

Prescription (U.S.)

Jobs

Melasma · Post-inflammatory hyperpigmentation · Dark spots

Watch for

Prescription-only in the U.S. since 2020; any OTC or imported 'whitening' cream containing it is unapproved. Use in cycles of a few months, never continuously.

Access

Prescription 4% cream is inexpensive; the approved triple-combination cream is costly and often not covered. Telehealth compounding is common; check the pharmacy.

Forms and strengths

4% cream (Rx; most products are marketed without FDA approval)
Triple combination 4% hydroquinone / 0.05% tretinoin / 0.01% fluocinolone (Rx, the only FDA-approved product)
Compounded higher strengths (Rx)

How to use it

Thin layer to the spots nightly for 8–12 weeks, then a break; daily broad-spectrum sunscreen is mandatory or the pigment returns. Many clinicians alternate with azelaic acid or tranexamic acid during breaks.

Side effects and cautions

Irritation and redness
Halo lightening around spots
Exogenous ochronosis (blue-black discoloration) with prolonged or high-strength use

Get advice first if

Not recommended in pregnancy. Stop and seek care if darkening or blue-black patches appear. Imported skin-lightening products have been found to contain mercury and undisclosed hydroquinone.

Regulatory status

Under the 2020 CARES Act, OTC hydroquinone is no longer legally marketed in the U.S.; FDA issued warning letters in 2022 and says the triple-combination cream is the only approved hydroquinone product. Banned in E.U. cosmetics; prescription elsewhere.

In the trends

Trending in the wrong direction: 'glow' creams from overseas marketplaces are where FDA keeps finding mercury and hydroquinone.

Sources on file

These links support the claims above. Reviewed September 1, 2026. Drug labels link to DailyMed searches so the current label is always one click away.