email@example.com | (512) 243-6426
Antimicrobial Wash Products include antibacterial hand washes, hand soaps, and body washes. These antiseptic products are lathered with the aid of water, and then the hands or body is rinsed and dried. Currently these products have not been shown to prevent illness more effectively than plain soap and water, and because there are concerns regarding the long-term use and impact of these consumer products the FDA and CDC recommend using plain soap and water for home and public handwashing.2 The FDA is currently reviewing OTC antiseptics, and has published a final ruling that amends the 1994 Tentative Final Monograph (TFM)3 and has identified certain active ingredients used in consumer antiseptic washes that are not generally recognized as safe and effective (GRAS/GRAE).4 The antimicrobial effectiveness of antiseptic wash products can be tested following procedures based on ASTM Standards such as E2870, E2784, E2276, E1174 (bacteria specific), E1838 (virus specific), and E2613 (fungi specific).
Antimicrobial Rub Products, like the alcohol-based hand rubs and other leave-on formulations, are designed to be applied full strength, rubbed-in until dry, and used without water rinsing. They are a convenient alternative to hand washing, especially when a water source is not available. These products may also be tested for antimicrobial efficacy using protocols based on ASTM Test Methods such as E2276, E1838, and E2613. In addition, the FDA is now proposing an amendment to the TFM that would include additional in vitro effectiveness data be obtained in order to support GRAS/GRAE branding for consumer antimicrobial rub active ingredients.5
- Public domain photos of Handwash and Handsanitizer from FDA website. http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm444681.htm
Topical Antiseptic Products: Hand Sanitizers and Antibacterial Soaps http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm444681.htm
Federal Register Notice: Tentative Final Monograph for OTC Healthcare Antiseptic Drug Products – June 17, 1994 http://www.fda.gov/ohrms/dockets/ac/05/briefing/2005-4184B1_01_16-FDA-TAB15.pdf
Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use. A Rule by the Food and Drug Administration on 09/06/2016. https://www.federalregister.gov/documents/2016/09/06/2016-21337/safety-and-effectiveness-of-consumer-antiseptics-topical-antimicrobial-drug-products-for
Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record A Proposed Rule by the Food and Drug Administration on 06/30/2016. https://www.federalregister.gov/documents/2016/06/30/2016-15410/safety-and-effectiveness-of-consumer-antiseptics-topical-antimicrobial-drug-products-for