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C.B. FLEET'S YEAST-X ANTI-ITCH CREAM AND FEMININE POWDER CITED BY FDA

This article was originally published in The Tan Sheet

Executive Summary

C.B. FLEET'S YEAST-X ANTI-ITCH CREAM AND FEMININE POWDER CITED BY FDA in a recent warning letter for implying that the products treat vaginal yeast infections. The agency noted that "it is our position that the term 'Yeast-X' in the product name in conjunction with" statements made in labeling "indicates that the two products are intended for the treatment of vaginal yeast infections and the irritation that can accompany such infections." However, the Yeast-X products "do not contain any ingredients which are generally recognized as an effective treatment," FDA pointed out. The agency underscored that only two ingredients, clotrimazole and miconazole, have been approved by FDA via the Rx-to-OTC switch route for the treatment of vaginal yeast infections after a physician has made an initial diagnosis. FDA said it is "not aware of any adequate and well-controlled studies published in the literature that indicate that a product containing any of [the ingredients contained in Yeast-X] is safe and effective for the treatment of vaginal yeast infections." The active ingredients in the Yeast-X Anti-Itch Cream and Feminine Powder are hydrocortisone and zinc oxide, respectively. Based on an October 1992 inspection and a "recent update inspection" of Lynchburg, Va.-based C.B. Fleet, FDA discovered that labeling for Yeast-X Medicated Anti-Itch Cream stated that the product is intended "for the temporary relief of external feminine itching, and itching associated with minor skin irritations, inflammation and rashes." Labeling also emphasized that the product's active ingredient is 1% hydrocortisone and included the phrase: "If using Yeast-X for temporary relief of itching due to a yeast infection. . . ." FDA charged that labeling statements for Yeast-X Medicated Anti-Itch Cream "are not in accordance with the required labeling for interim marketing of over-the-counter drug products containing from .5% to 1% hydrocortisone" or its hydrocortisone acetate equivalent. Because hydrocortisone is an Rx-to-OTC switch, "there can be no deviation from the required language," the agency added. Regarding Yeast-X Medicated Feminine Powder With Zinc Oxide, FDA observed that labeling for the product asserted that it "soothes itching," "absorbs moisture," and is "especially formulated with zinc oxide, a proven medicated skin protectant to soothe minor feminine irritations and reduce chaffing in sensitive areas." Labeling for the powder also noted that it is "gentle enough to be used on even a baby's skin" and "its benzethonium chloride ingredient helps neutralize odor." Consumers are instructed to "apply to the external vaginal area after bathing or whenever you feel the need." Active ingredients listed for the Yeast-X Medicated Feminine Powder include topical starch USP (corn starch) and zinc oxide; labeling also said that the product "contains benzethonium chloride." "We are unaware of any substantial scientific evidence that documents that this drug is generally recognized as safe and effective for the treatment, cure, mitigation or prevention of its labeled indications," FDA concluded. In a June response to the agency, C.B. Fleet said that it disagreed with the citations in the warning letter. The company is currently awaiting a reply from FDA. The warning letter to C.B. Fleet represents at least the third time in recent months that a company has been cited by the agency for marketing products to treat vaginal yeast infections. In May, FDA issued warning letters to Lake Pharmaceutical for Yeast-Gard and Bezwecken for Yeastat, asserting that the products in question are not effective for treating yeast infections ("The Tan Sheet" June 14, p. 16).
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