Antimicrobial Drugs

Antimicrobial drugs include all drugs that work against a variety of microorganisms, such as bacteria, viruses, fungi, and parasites. There are several classes of antimicrobial drugs, each with its own mechanism of action and spectrum of activity.

Antibacterial soap

In the 1994 TFM, FDA concluded not to include “antimicrobial soap” as a separate product category because soap is a dosage form, and specific dosage forms were not included in the monograph unless there was a particular safety or efficacy reason to do so. Hence the products with the intended use of being used on the entire body have been classified as antiseptic body wash.

As per the rulemaking History, antimicrobial drugs products are classified into three categories, First Aid Antiseptic, Consumer Antiseptic, Healthcare Antiseptic.

Consumer Antiseptic Drugs

Consumer Antiseptic Drugs has been further divided into Consumer Antiseptic washes and Consumer Antiseptic rubs.

Consumer Antiseptic washes (Antiseptic hand wash and body wash)

Consumer antiseptic products intended for use with water and rinsed off after use

Active Ingredients	Regulatory Citation	OTC Monograph
Benzalkonium chloride	Part 333	Consumer Antiseptic Washes
Benzethonium chloride	Part 333	Consumer Antiseptic Washes
Chloroxylenol	Part 333	Consumer Antiseptic Washes

Consumer Antiseptic Rubs (Hand Sanitizer)

Consumer antiseptic products intended for use without water and left on the skin.

Active Ingredients	Regulatory Citation	OTC Monograph
Benzalkonium chloride	Part 333	Consumer Antiseptic Rubs
Ethyl alcohol	Part 333	Consumer Antiseptic Rubs
Isopropyl alcohol	Part 333	Consumer Antiseptic Rubs

Health Care Antiseptic Drugs

Healthcare antiseptics are drug products that are generally intended for use by healthcare professionals in a hospital setting or other healthcare situations outside the hospital.

Health Care Antiseptic are classified as Health care personnel hand washes, Health care personnel hand rubs, Surgical hand scrubs, Surgical hand rubs, Patient antiseptic skin preparations (i.e., patient preoperative and preinjection skin preparations)

Healthcare Personnel Hand Washes

The product is rinsed off with water after use.

Active Ingredients	Regulatory Citation	OTC Monograph
Benzalkonium chloride	Part 333	Health Care Antiseptic
Benzethonium chloride	Part 333	Health Care Antiseptic
Chloroxylenol	Part 333	Health Care Antiseptic
Povidone-iodine	Part 333	Health Care Antiseptic

Healthcare Personnel Hand Rubs

Rubs are “leave-on products” and are not rinsed off after use.

Active Ingredients	Regulatory Citation	OTC Monograph
Alcohol	Part 333	Health Care Antiseptic
Benzalkonium chloride	Part 333	Health Care Antiseptic
Isopropyl alcohol	Part 333	Health Care Antiseptic

Patient Antiseptic Skin Preparation

This is a rub and leave-on products and are not rinsed off after use.

Active Ingredients	Regulatory Citation	OTC Monograph
Alcohol	Part 333	Health Care Antiseptic
Benzalkonium chloride	Part 333	Health Care Antiseptic
Benzethonium chloride	Part 333	Health Care Antiseptic
Chloroxylenol	Part 333	Health Care Antiseptic
Povidone-iodine	Part 333	Health Care Antiseptic
Isopropyl alcohol	Part 333	Health Care Antiseptic

Surgical Hand Scrubs

These are washes and rinsed off with water after use.

Active Ingredients	Regulatory Citation	OTC Monograph
Benzalkonium chloride	Part 333	Health Care Antiseptic
Benzethonium chloride	Part 333	Health Care Antiseptic
Chloroxylenol	Part 333	Health Care Antiseptic
Povidone-iodine	Part 333	Health Care Antiseptic

Surgical Hand Rubs

This is a rub and leave-on product and is not rinsed off after use.

Active Ingredients	Regulatory Citation	OTC Monograph
Alcohol	Part 333	Health Care Antiseptic
Isopropyl alcohol	Part 333	Health Care Antiseptic