How do the companies that sell antibacterial soap and hand cleaners label their products?

Why do they print directions on the back of your liquid antibacterial hand soap bottle? Do you really need “directions” on how to use soap?

Antibacterial products used to clean bathrooms or kitchen sinks are not drugs, and therefore their labeling is regulated by the Federal Trade Commission. Same for ordinary (i.e., non-antibacterial) soap.

But if a product intended for use on or in humans claims that it is antibacterial or makes any other medical claim (such as that it will cure dandruff, grow hair, or prevent acne), then the Food and Drug Administration classifies it as a drug, and it falls under their purview. The Environmental Protection Agency has a role in this regulation as well, as we will see later.

If a manufacturer wants to sell a drug, even an over-the-counter drug, he must follow many regulations that involve a great deal of reporting, registering, renewing registrations, submission of forms, complying with standards, obeying quality control and labeling requirements, undergoing periodic inspections, and assuring that the ingredients are both safe and effective for the purpose they are supposed to accomplish.

It is not a procedure that can be taken lightly, so all of the companies that sell antibacterial soap or hand cleaners must spend considerable time, effort, and money before they can do so. They obviously feel that it is worth the trouble.

The labeling requirements are quite demanding. Every label has to say what antiseptic is in it. It must include indications for when it is to be used, and directions for proper use. It must include warnings like “for external use only,” or “do not use in eyes,” or “discontinue if redness or irritation develop.”

Manufacturers are not allowed to use “antibacterial” as an indication, although they are allowed to make general statements like “Contains antibacterial ingredients.” Approval by the FDA also requires that the product be tested and found effective, and must include animal and in vitro testing. The testing also has to determine how quickly the drug achieves its antimicrobial effect, and all this must be reported to the FDA.

When an antibacterial hand soap boasts in its advertising that it has been “scientifically tested and found effective” or “approved by the FDA,” the manufacturer is making a virtue of necessity. Colgate Total toothpaste, for example, claims in its advertising that “Colgate Total is the ONLY toothpaste approved by the FDA and accepted by the American Dental Association to help prevent plaque and gingivitis.”

That’s true, and Colgate can say so, because in 1997 the company received approval from the FDA to include the antibiotic triclosan in the toothpaste. Other makers of toothpaste are free to do the same thing. Colgate Total toothpaste, as far as the FDA is concerned, is an over-the-counter drug. On the labels of antibacterial products, you will see an 800 number that you can call “for questions or comments.”

The manufacturer may have set up this number out of the goodness of his heart, but in any case the FDA requires the company to do so and requires it to have a live person answering it.