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Benzalkonium Chloride News

FDA Asks How Safe Is That Hand Sanitizer?

Posted 29 Jun 2016 by Drugs.com

WEDNESDAY, June 29, 2016 – Millions of Americans use hand sanitizers every day, believing they safely kill bacteria. Now, the U.S. Food and Drug Administration wants to find out if that's really true. The agency Wednesday requested makers of antibacterial hand sanitizers and related products to provide data showing the products' active ingredients actually reduce bacteria and are harmless over time. Of particular concern are the long-term effects of these sanitizers on pregnant women and children, the agency said. "These products provide a convenient alternative when hand washing with plain soap and water is unavailable, but it's our responsibility to determine whether these products are safe and effective so that consumers can be confident when using them on themselves and their families multiple times a day," Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and ... Read more

Related support groups: Infections, Benzalkonium Chloride, Ethanol, Ethyl Alcohol, A + D Cracked Skin Relief, Swim Ear, Dehydrated Alcohol, Isopropyl Alcohol, Benzocaine/Isopropyl Alcohol, Benza, Denatured Alcohol, Auro-Dri, First Aid Antiseptic, Herpetrol, BD Single Use Swab, Benzalkonium Chloride/Benzocaine, Mercuroclear, Iodine Povacrylex/isopropyl Alcohol, Butterfly Alcohol Pad, Benzalkonium Chloride/Menthol

FDA Seeks to Improve Safety of Antiseptic Swabs

Posted 14 Nov 2013 by Drugs.com

THURSDAY, Nov. 14 – Manufacturers of antiseptic swabs and solutions are being asked to make voluntary labeling and packaging changes, the U.S. Food and Drug Administration said Thursday. The goal is to improve the products' safety when applied to the skin before surgery or injections. Reports of infections linked to the over-the-counter antiseptics are infrequent but continuing, the agency said in a statement explaining its request. When used properly, these antiseptic swabs and solutions safely reduce the number of bacteria on patients' skin before they undergo an operation or receive shots. But use of contaminated antiseptics has led to localized infections and even death, according to the FDA. "Most often, contamination of [antiseptic products] occurs when organisms are introduced into the product by users," the agency said in the news release. The FDA is asking for labeling changes ... Read more

Related support groups: Chlorhexidine, Hibiclens, Benzalkonium Chloride, Peridex, Betasept, Dyna-Hex, Isopropyl Alcohol, Perisol, Benzethonium Chloride, Denatured Alcohol, Benza, Lugols Strong Iodine, Skin Disinfection, Preoperative, Lugols Solution, Pedi-Pro (Benzalkonium), Topical Disinfection, Hibistat, Calgon Vesta, PerioChip, Alcare Plus

FDA Medwatch Alert: Over-the-Counter Topical Antiseptic Products: Drug Safety Communication - FDA Requests Label Changes and Single-Use Packaging to Decrease Risk of Infection

Posted 13 Nov 2013 by Drugs.com

ISSUE: The U.S. Food and Drug Administration (FDA) is requesting label and packaging changes to enhance the safe use of certain over-the-counter (OTC) topical antiseptic products. This request is the result of our ongoing evaluation of infrequent but continuing reports of infections resulting from antiseptic products labeled for preoperative or preinjection skin preparation.  When used properly, topical antiseptics are safe and effective products to reduce the number of bacteria on patients’ skin prior to surgery or injections.  However, most often, contamination of topical antiseptics occurs when organisms are introduced into the product by users.  Therefore, health care professionals and patients should follow all label directions to decrease the chances of infection. Outbreaks associated with the use of contaminated topical antiseptics have been reported in the medical literature and ... Read more

Related support groups: Chlorhexidine, Hibiclens, Benzalkonium Chloride, Peridex, Betasept, Dyna-Hex, Isopropyl Alcohol, Perisol, Benzethonium Chloride, Denatured Alcohol, Benza, Lugols Strong Iodine, Lugols Solution, Pedi-Pro (Benzalkonium), Hibistat, Calgon Vesta, PerioChip, Alcare Plus, Iodine Mild, Denti-Rinse

FDA Medwatch Alert: Benzalkonium Chloride Antiseptic Wipes by Dukal: Recall - Potential Microbial Contamination

Posted 1 Aug 2012 by Drugs.com

ISSUE: Dukal Corporation announced a U.S. voluntary nationwide recall of selected lots of benzalkonium chloride swabs and antiseptic wipes manufactured for Dukal by Jianerkang Medical Dressing Co. This recall is being initiated due to concerns about potential microbial contamination with Burkholderia cepacia. Use of contaminated wipes could lead to infections, some of which pose health risks in immune-suppressed patients. BACKGROUND: Benzalkonium chloride antiseptic wipes are sold separately over-the counter and in kits. These products were distributed nationwide to the wholesale and retail levels.  RECOMMENDATION: All customers are advised to discontinue use of products identified in this recall immediately and should dispose of the product. See the Press Release for a listing of lot numbers affected by this recall. Healthcare professionals and patients are encouraged to report a ... Read more

Related support groups: Bacterial Infection, Benzalkonium Chloride, Benza, Pedi-Pro (Benzalkonium), CureChrome, Zephiran Chloride

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Further Information

Related Condition Support Groups

Topical Disinfection

Related Drug Support Groups

Benza, Zephiran Chloride, CureChrome, Merthiolate, Pedi-Pro (Benzalkonium)

Benzalkonium Chloride Patient Information at Drugs.com