FDA is undertaking a review of active ingredients used in a variety of over-the-counter (OTC) antiseptic rubs and wash products. Health care antiseptics are being evaluated separately from consumer antiseptics because they have different proposed use settings and target populations, and the risks for infection in the different settings varies. More information about both is presented below.
What are antiseptics?
Over-the-counter consumer antiseptics can generally be broken down into two groups: washes and rubs. The definition for each is below.
Antiseptic wash products, also known as antibacterial soaps, are intended for use with water and are rinsed off after use, and include hand washes /soaps and body washes.
FDA supports the CDC’s recommendation to use plain soap and water to wash your hands. When water is not readily available, a hand sanitizer may be a suitable alternative.
Rubs are leave-on products, or hand “sanitizers,” as well as antiseptic wipes. These products are intended to be used when soap and water are not available, and are left on and not rinsed off with water.
Remember: Just like with all over-the-counter drugs, it is important to read the label every time you use hand sanitizers or antiseptic wipes. These products should be stored out of the reach of children and should be used with adult supervision. Use hand sanitizers and antiseptic wipes only as directed on the label. Do not swallow them. If you swallow these products call a poison control center immediately.
What is the difference between health care antiseptics and consumer antiseptics?
Health Care Antiseptics
Health care antiseptics differ from consumer antiseptics in the following ways:
- They are primarily used by health care professionals in hospitals, clinics, doctors’ offices, outpatient settings and nursing homes.
- Health care antiseptics are not only used to protect the user but also to protect the patient, whereas consumer antiseptics are generally applied to protect the user.
- Health care antiseptics are often used more frequently by health care workers than consumers use consumer antiseptics.
Consumer antiseptics differ from healthcare antiseptics in the following ways:
- Consumer antiseptics are primarily used in the home, schools, daycares or other public settings.
- Most consumer antiseptics are sold in retail establishments like drug stores and grocery stores.
How are health care and consumer antiseptics being evaluated?
FDA compares the risks and the benefits for active ingredients under specified conditions of their use to help determine whether that active ingredient is generally recognized as safe and effective (GRASE). Since FDA’s 1994 evaluation of OTC antiseptics, many things have changed, including the frequency of use of some products, new technology that can detect low levels of antiseptics in the body, FDA’s safety standards, and scientific knowledge about the impact of widespread use. FDA’s current effort is designed to ensure that the safety and effectiveness evaluations and determinations for active ingredients used in antiseptics are consistent, up-to-date, and appropriately reflect current scientific knowledge and increasing use patterns.
FDA proposed that data was needed from a standard battery of tests that is used to determine the safety of many drugs, including OTC antiseptics. This array of tests has changed over time to incorporate improvements in safety testing. For more specific information on safety tests, please see the final rule on consumer antiseptic washes, the final rule on health care antiseptics, and the final rule on consumer antiseptic rubs.
For consumer antiseptic washes, millions of Americans use antiseptic hand soaps and body washes each day, but these products have not yet been shown to be more effective at preventing illness than plain soap and water. Additionally, emerging data have raised concerns that long-term, daily use of these products may outweigh their presumed benefits. The clinical studies data on effectiveness would specifically need to demonstrate that the active ingredients in consumer antiseptic wash products are superior to non-antibacterial soap in preventing illness or reducing infection. FDA has issued a final rule requiring the removal of certain active ingredients from OTC consumer antibacterial hand soaps and body washes including the most commonly used triclosan and triclocarban. Antibacterial manufacturers did not provide the necessary data to demonstrate the effectiveness for these active ingredients and so the FDA could not determine that they are generally recognized as safe and effective for use in consumer antiseptic washes. For more specific information on effectiveness testings for active ingredients used in consumer antiseptic washes, please see the final rule on consumer antiseptic washes.
FDA is not proposing clinical outcome studies for active ingredients when used in health care antiseptics or in consumer antiseptic rub products. FDA is requiring clinical simulation studies for health care antiseptics because of ethical concerns with conducting studies in the health care setting; FDA is requiring the clinical simulation studies for consumer antiseptic rubs because these products are intended for use when soap and water are not available, and so they need not demonstrate clinical effectiveness compared to soap and water. For specific information on the efficacy data requested for health care antiseptics and consumer antiseptic rubs, please see the final rules on health care antiseptics and final rule on consumer antiseptic rubs and their respective dockets.
- Rulemaking History for OTC Topical Antimicrobial Drug Products
- Regulatory Information for Topical Antiseptic Products
Health care antiseptics
- Topical Antiseptic Drug Products
- Q&A for Consumers: Health Care Antiseptics
- Q&A for Health Care Professionals: Health Care Antiseptics
- Nonprescription Drugs Advisory Committee Meeting Presentation Materials (PDF - 2.3MB)
- CDC: Hand Hygiene in Health Care Settings
- FDA issues final rule on safety and effectiveness of consumer hand sanitizers, 2019
- If Soap and Water Are Not Available, Hand Sanitizers May Be a Good Alternative, 2019
- FDA issues final rule on safety and effectiveness of antibacterial soaps
- Consumer Update: FDA Taking Closer Look at 'Antibacterial' Soap
- Consumer Update: Triclosan: What Consumers Should Know
- FDA requests additional information to address data gaps for consumer hand sanitizers
- Hand Sanitizers Carry Unproven Claims to Prevent MRSA Infections
- CDC: Handwashing: Clean Hands Save Lives
- FDA issues proposed rule to determine safety and effectiveness of antibacterial soaps
- Consumer Update: Triclosan: What Consumers Should Know
- EPA: Triclosan Facts
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