Hydroquinone and the (FDA) OTC Monograph
What is Hydroquinone?
Dr. Katie Rodan and Dr. Kathy Fields consider hydroquinone “the gold standard”. Hydroquinone has been used by
dermatologists for more than 40 years to lighten hyperpigmentation. The Food and Drug Administration (FDA) cre-
ated the skin bleaching OTC (Over-the-Counter) Monograph in 1982 and currently allows over-the-counter sales of
products with 1.5% to 2% hydroquinone, such as the Rodan + Fields REVERSE Skin Lightening Toner and Skin
Lightening Treatment. When used evenly over the entire face, hydroquinone reduces the appearance of discolorations
to create a more even skin tone.
Hydroquinone is found naturally in a wide variety of foods, including, berries, pears, wheat, and coffee making it likely
that we ingest far more hydroquinone than we absorb topically from skin creams containing either OTC 2% or pre-
scription 4% hydroquinone applied to limited areas of the face or body.
What is an OTC Monograph?
The FDA creates regulatory standards for non-prescription drugs (OTC Monograph) following a three phase rule mak-
ing process to determine safety and effectiveness. REVERSE Skin Lightening Toner and Skin Lightening Treatment
comply with all applicable FDA regulations.
How Does Hydroquinone Lighten the Skin?
Excessive amounts of melanin (pigment) production result from exposure to UV radiation, heat and other sources
of injury to the skin, such as healing from acne. Excessive melanin production may appear as freckles, age spots,
post-acne dark marks, or general dull appearance. Hydroquinone works by inhibiting tyrosinase, a key enzyme in the
physiological pathway that produces excessive pigmentation and is the only ingredient recognized for skin lightening
in the OTC Monograph.
Once the Skin is Lightened, Can Dullness and Dark Marks Return?
Yes. Treatment with hydroquinone is not a permanent correction for dullness, age spots or dark marks. Exposure to
UV light will trigger the return of the abnormal pigmentation and uneven pigmentation. That is why it is imperative that
broad-spectrum sunscreen, as well as protective clothing be used every day to protect skin from the damage caused
by sun exposure.
Why is Hydroquinone Under Scrutiny?
Tests involving the oral ingestion of high quantities of hydroquinone by laboratory rats resulted in the development of
tumors or liver damage. There has never been any link between the topical application of hydroquinone and such
outcomes in humans. Buildup of blue-black pigment in skin (ochronosis) has been observed in Africa after long term
application of high doses (typically 5 times higher than what is permitted in the US) of low-grade hydroquinone over
large areas of the body. Rarely has ochronosis been observed in the United States associated with appropriate use of
medical grade hydoquinone at the recommended dosage for topical application.
Is Hydroquinone Safe? Is it Sold in Europe and Asia?
Europe and Asia currently allow hydroquinone at 2-5% concentration by prescription. The drug is valued worldwide
but is regulated to protect against misuse and bad formulations.
What are Some Alternatives?
Hydroquinone is the only skin lightener recognized by the FDA OTC monograph. Skin brighteners, like licorice, kojic
acid, and bearberry extract to name a few, do not lighten brown discolorations but rather provide brightening of a
Since its inception for use as a pharmaceutical treatment for excessive / irregular skin pigmentation, there has been
an extremely low rate of reported side effects in the United States. Further, most reported adverse effects outside
the U.S. are associated with a questionable grade of material and likely due to contaminants or extreme misuse.
Dr. Rodan and Dr. Fields have prescribed hydroquinone throughout their years of medical practice, have used it on
their own skin, and have formulated with it in numerous skincare products. They recognize it as the cornerstone for
the treatment of uneven pigmentation and dullness associated with sun damage, hormones, and post inflammatory
hyperpigmentation following a healed acne lesion.
It is the goal of Rodan + Fields Dermatologists to provide our customers with safe and effective products and we will
follow the FDA’s position concerning hydroquinone.
Hydroquinone is not recommended during pregnancy and breast feeding because studies have never been per-
formed and therefore risk to a fetus is unknown.
If you are concerned about using hydroquinone, check with your health professional. We are absolutely committed to
our customers’ safety.