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Black and White ointment

This article was originally published in The Tan Sheet

Executive Summary

Marketer J. Strickland & Co. to modify labeling to comply with OTC skin protectant monograph in response to June 17 FDA warning letter. As labeled, for "the temporary relief of itching, burning and stinging caused by acne pimples or eczema," the petrolatum-based ointment is an unapproved new drug, FDA tells the company. As a result, labeling for the petrolatum-based product will state "For temporary protection of minor scrapes, cuts and burns" and "Helps to prevent and temporarily protect chapped, cracked or windburn skin." The Memphis-based company markets topical OTCs and cosmetics to food, drug and mass market outlets; other products include Sulfur 8 dandruff shampoo and Nadinola skin care products...
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