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1/29/2003

New Lotion Approved for Acne, Rosacea

Cheryl A. Thompson

Bradley Pharmaceuticals announced Monday that the Food and Drug Administration had approved the marketing of Rosula Lotion, containing 10 percent sodium sulfacetamide and 5 percent sulfur in an emulsion with 10 percent urea.

According to the product's labeling, the lotion is indicated for the topical control of common acne, rosacea, and seborrhea.

At least three lotions containing 10 percent sodium sulfacetamide and 5 percent sulfur were on the market before the recent approval of Rosula. Bradley said the urea in its lotion "soothes and relieves redness and inflamed skin."

The new lotion is contraindicated in patients known to be highly sensitive to sulfonamides, sulfur, or a component of the emulsion. Also according to the labeling, patients with kidney disease should not use the product.

The instructions for use of the product call for patients to cleanse the affected areas of the skin and then apply a thin film of the lotion to those areas one to three times daily.

A spokesman for the company said that drug wholesalers already have the new product, which is packaged in 45-g tubes.