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  • Title: Pediculicide drug products for over-the-counter human use; amendment of final monograph. Final rule.
    Author: Food and Drug Administration, HHS.
    Journal: Fed Regist; 2003 Dec 31; 68(250):75414-8. PubMed ID: 14986677.
    Abstract:
    The Food and Drug Administration (FDA) is issuing a final rule amending the final monograph (FM) 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. FDA is issuing this final rule as part of its ongoing review of OTC drug products after considering public comment on its proposed regulation and all relevant data and information that have come to the agency's attention.
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