Which statement about antiseptics is correct?

• A. They are used only on surfaces
• B. They are regulated by the FDA
• C. Alcohol-based antiseptics must be 100%
• D. They are not regulated by the FDA

Answer: (B)

Antiseptics used on living tissue are regulated by the FDA, which means they must meet safety, labeling, and efficacy requirements as drugs. This oversight ensures that products applied to the skin—such as hand antiseptics and pre-procedural preparations—list active ingredients and concentrations clearly, include appropriate usage instructions and warnings, and meet standards to protect clients and practitioners. The idea that antiseptics are regulated only for surfaces isn’t correct because the regulatory focus shifts when the product is intended for use on skin.

Also, alcohol-based antiseptics do not have to be 100%—in fact, a bit of water is essential for effectiveness. Most effective skin antiseptics contain about 60–95% alcohol; water aids in denaturing proteins and slows evaporation, giving the antiseptic time to work. Pure, 100% alcohol evaporates too quickly and is less effective.

So, the correct statement reflects FDA regulation of these products as drugs and the practical reality that they are used on skin, not just surfaces, and that they don’t need to be (and shouldn’t be) fully anhydrous.