FDA Registration for Antimicrobial Drug Products

OTC consumer antiseptic handwash, antiseptic rub (hand sanitizer) and antimicrobial soap products are regulated as OTC Monograph drugs by FDA — requiring drug establishment registration, NDC labeler code, and Drug Facts labeling.

OTC MonographDrug Facts Labeling21 CFR Part 207Since 2009

FDA Requirements for Antimicrobial Drug Products

OTC consumer antiseptic products (antimicrobial hand soaps, antiseptic rub (hand sanitizer), body washes) are regulated as drugs by FDA. Benzalkonium chloride is a commonly used active ingredient.

FDA’s final rule (effective September 2017) made most active ingredients (including triclosan) not GRASE for use in consumer antiseptic handwash products.

FDA Drug Establishment Registration
NDC Labeler Code
Drug Listing with Drug Facts labeling
Annual renewal October 1–December 31

Antimicrobial drugs include all drugs that work against a variety of microorganisms. 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. Personal care products intended to be used with water are classified as Consumer antiseptic washes.

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

For more information about FDA Antimicrobial Drug registration and listing or to register and list your Antimicrobial product with US FDA please contact us at info@fdahelp.us

These are not complete list of ingredients in FDA OTC drug monograph. The status of ingredient in OTC monograph may change please contact FDA for updated information.