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.

First Aid Antiseptic Drugs

First aid antiseptic drug product is applied topically to the skin to help prevent infection in minor cuts, scrapes, and burns.

Active Ingredients

Regulatory Citation

OTC Monograph

Alcohol

Part 333

First Aid Antiseptic

Benzalkonium chloride

Part 333

First Aid Antiseptic

Benzethonium chloride

Part 333

First Aid Antiseptic

Camphorated metacresol

Part 333

First Aid Antiseptic

Camphorated phenol

Part 333

First Aid Antiseptic

Eucalyptol

Part 333

First Aid Antiseptic

Hexylresorcinol

Part 333

First Aid Antiseptic

Hydrogen peroxide topical solution

Part 333

First Aid Antiseptic

Iodine tincture

Part 333

First Aid Antiseptic

Iodine topical solution

Part 333

First Aid Antiseptic

Isopropyl alcohol

Part 333

First Aid Antiseptic

Menthol

Part 333

First Aid Antiseptic

Methylbenzethonium chloride

Part 333

First Aid Antiseptic

Methyl salicylate

Part 333

First Aid Antiseptic

Phenol

Part 333

First Aid Antiseptic

Povidone-iodine

Part 333

First Aid Antiseptic

Thymol

Part 333

First Aid 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.

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