Pediculicide Drug Products for Over-the-Counter Human Use; Proposed Amendment of Final Monograph

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The Food and Drug Administration (FDA) is proposing to amend the final monograph for over-the-counter (OTC) pediculicide drug products to revise labeling for the statement of identity, warnings, directions, and other required statements. Pediculicide drug products are used for the treatment of head, pubic (crab), and body lice. This proposal is part of FDA's ongoing review of OTC drug products.