Pharmacy Services

Over-the-Counter Topical Antiseptics

November 18, 2013

FDA announced new labeling and packaging changes for OTC topical antiseptic products labeled for pre-operative and pre-injection skin preparation. FDA has requested that manufacturers package these products in single-use containers and indicate sterility of the antiseptic on the product label in an effort to promote safe use of these products.  Local and systemic infections, including 4 deaths, caused by contaminated antiseptic products have been reported to FDA and CDC.  These infections are linked to inappropriate handling of the antiseptic by the user as well as contamination during the manufacturing process.  The new labeling and packaging requirements apply to all commonly used OTC antiseptics (eg, benzalkonium chloride, benzethonium chloride, chlorhexidine gluconate, ethyl or isopropyl alcohol, poloxamer iodine, povidone iodine).  A summary of the updates and recommendations for use are presented below.

  • Manufacturers will produce single-use packages for topical antiseptics labeled for pre-operative and pre-injection skin preparation.
  • Manufacturers will indicate on the package labeling if the antiseptic was prepared in a sterile or non-sterile environment.
  • Only use topical antiseptics according to the labeled directions.
  • Discard unused antiseptic product and applicators after one application to a single patient.
  • Do not dilute antiseptic products.

Additional information is available at the following links:

Updated
November 18, 2013; University of Utah, Drug Information Service. Copyright 2013, Drug Information Service, University of Utah, Salt Lake City, UT.