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