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More than 1 million children annually are affected by head lice (pediculosis capitis), the agency said in a news release. The newly approved medication was established as safe and effective in two studies of 628 people. After two, 10-minute treatments given a week apart, more than 75% of trial participants treated with the lotion were lice free.
The most common side effects of the treatment were irritations of the skin, scalp and eyes, and application site numbness.
The treatment is distributed by Sciele Pharma Inc.
-- Scott Roberts
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