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...
You may also be interested in...
Supplement GMP Warning Letters Make Modest Debut In 2010
Finalization of a settlement between the Federal Trade Commission and Rexall Sundown regarding unsupported cellulite treatment claims for the firm's Cellasene dietary supplement hinges upon approval of two related class action settlements pending in California and Florida, according to FTC
In Brief
Combe sells most of its OTC brands
People In Brief
Perrigo promotes in pricing, planning