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Clinique Exceptionally Soothing info booklets created in response to FDA warning letter.

This article was originally published in The Rose Sheet

Executive Summary

CLINIQUE EXCEPTIONALLY SOOTHING INFORMATION BOOKLETS TO BE DISTRIBUTED by "trained Clinique consultants" as part of a relabeling effort initiated by the Estee Lauder division following a Dec. 15 FDA warning letter. The letter cites Clinique for mislabeling its OTC products Exceptionally Soothing Cream for Upset Skin and Lotion for Upset Skin with .5% hydrocortisone. In a Jan. 21 response, Lauder says it will distribute an information booklet to all consumers purchasing" the lotion or cream that clarifies the products' intended usage, instructions, warnings and expiration dates. The company assured FDA it would "take every step to ensure that the products are labeled in full compliance with the law" as set forth in the tentative final monograph for the OTC ingredient hydrocortisone.
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