Hydroquinone Overview

What is hydroquinone (HQ)?

Hydroquinone is a skin bleaching ingredient used to reduce the appearance of dark spots on the skin. It has been used safely and effectively for more than 40 years.

How does the U.S. Food and Drug Administration (FDA) currently classify hydroquinone?

The US Food and Drug Administration (FDA) classifies hydroquinone as a skin bleaching ingredient used to lighten areas of darkened skin.

Is hydroquinone considered a drug?

The FDA considers hydroquinone a drug.  Hydroquinone is currently distributed over-the-counter at 2% potency and pursuant to a physician’s order or by prescription through a pharmacy at 4% strength.


Safety & Effectiveness

Is 4% HQ safe when used under a physician’s care?

4% HQ, which is only available by prescription, has been prescribed to  patients suffering from skin conditions such as discoloration caused by overexposure to the sun, hyperpigmentation, and soft tissue deficits, all without a single reported adverse event. Products that include Hydroquinone 4% require education by a physician on proper use to minimize any risk from excess sun exposure to sensitive skin.

What about side effects?

An extremely rare side effect, ochronosis, which can lead to pigment discoloration of the skin, can be associated with overuse or inappropriate use of hydroquinone.  Hydroquinone 4% use should be managed by physicians who in the office can explain carefully the appropriate use of the product and the importance of sunscreen use.

How widely used is HQ?

Hydroquinone has been used in millions of patients and is a component of many products that are available to patients and consumers.   The lower dose products are available over the counter in most pharmacies.  The higher dose products are only available as a prescription.  Many physicians view hydroquinone as the gold standard for treating discolorations of the skin.

Is there a link between use of HQ and cancer?

No cases of skin cancer or internal malignancy in humans related to the topical application of hydroquinone have been reported in more than 40 years of manufacturing and use.

Over The Counter Access

Why is it important to have access to HQ?

Millions of patients are affected by dyschromias such as uneven skin tone, age spots and sun damage each year. Restricting skin bleaching drug products to prescription use only would eliminate a safe, effective, readily accessible and affordable treatment for millions of patients.

Who is affected by dyschromias?

Dyschromias affects millions of Americans each year but disproportionately affects minority patient populations including African Americans, Latinos and Asians. Removing a safe, effective and readily available treatment would pose an unnecessary burden on populations for whom health disparities abound.