Safety
Hydroquinone can cause exogenous ochronosis, a gradual blue-black darkening of the skin; stop if it appears. The FDA has reported rashes, facial swelling and skin discoloration with skin-lightening products. Blends with tretinoin are usually avoided in pregnancy, blends with a steroid are for short courses, and daily sunscreen is part of the treatment. Melasma usually returns when treatment stops.
Talk to a licensed clinician about your health history and every medication you take before you start.
Legal status
Prescription only; compounded and not FDA-approved. Prescription hydroquinone cream is prepared by a compounding pharmacy for an individual prescription. Compounded products are not FDA-approved, and the FDA does not review them for safety, effectiveness or quality. Lawful only as Tri-Luma or as a cream a pharmacy compounds for your prescription. Over-the-counter hydroquinone has been illegal since the 2020 CARES Act change, and the FDA warned 12 sellers in 2022. Compounded blends are not FDA-approved.
What prescription hydroquinone cream is
Prescription hydroquinone cream contains hydroquinone, usually 4% or more, often with tretinoin, a mild steroid or azelaic acid. The only FDA-approved hydroquinone drug is Tri-Luma (fluocinolone 0.01%, hydroquinone 4%, tretinoin 0.05%), for short-term treatment of moderate to severe melasma of the face. Since the CARES Act took effect on Sept 23, 2020, no over-the-counter hydroquinone product is legally marketed in the US.
Dosing
Cream, mixed by a compounding pharmacy (Tri-Luma is the approved version), in short courses. The blends we track use 4% hydroquinone (Nurx) up to 12% (Musely). Tri-Luma is a thin film once a day at least 30 minutes before bed, stopped once the melasma is under control; it is not for maintenance. Your clinician sets the dose for you.
How well it works
In two 8-week Tri-Luma trials of 641 adults with facial melasma, melasma cleared in 38% and 13% of people on the triple cream, against 15% and 4% on hydroquinone with tretinoin alone. Individual results vary.
Prescription hydroquinone cream cost
None of the online providers we compare publishes a monthly price for it. For a full breakdown, read How much does an online dermatologist cost?. For the steps, read How to get a tretinoin prescription online.