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October 1985

Safety of Over-the-Counter Hydroquinone Bleaching Creams

Author Affiliations

Revlon Research Center, Inc 2121 Route 27 Edison, NJ 08818

Arch Dermatol. 1985;121(10):1239. doi:10.1001/archderm.1985.01660100019002

To the Editor.—  In the January 1985 Archives, Hoshaw et al1 describe two patients, American blacks, who developed ochronosislike pigmentation "following the use of 2% hydroquinone-containing bleaching creams." Several over-the-counter (OTC) products are named and ascribed the concentration of 2% hydroquinone. In telephone conversations with two of the authors, I learned that no chemical assay was made of any product nor were the manufacturers consulted regarding the concentration of active agent contained in their products. The authors essentially relied on the 2% limit for OTC products contained in the Food and Drug Administration (FDA)-proposed monograph published in the Federal Register on Nov 3, 1978.Manufacturers may consider it prudent but not obligatory to follow FDA guidelines. Chemical assays of these OTC products have disclosed variation in quantity, even to an excess of 7%. Because patients who purchase bleaching creams will use many brands of such products, depending on satisfaction

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