Hand Sanitizers are regulated as over the counter (OTC) drug products by FDA.
US FDA has specific regulations to ensure their safety, effectiveness, and quality.
Below is an overview of key FDA regulations.
1. Active Ingredients:
FDA approved Hand Sanitizer active ingredients are as follows:
- Ethanol (ethyl alcohol) – typically in concentrations of 60% to 95%.
- Isopropyl alcohol – also commonly used at concentrations around 60% to 91%.
- Non-Alcohol active ingredient Benzalkonium chloride 0.1 to 0.13%., but alcohol-based hand sanitizers are the most common and effective.
2. Labeling Requirements:
Hand sanitizer products must comply with FDA drug labeling requirements which include:
- The active ingredient and its concentration.
- Directions for use (e.g., amount to use and when to use).
- Warnings (e.g., avoid contact with eyes, keep out of reach of children).
- Inactive ingredients, if applicable.
- Expiration date for the product if it has one.
- Drug facts label if it is marketed as an OTC product.
3. Manufacturing Standards:
Hand Sanitizer manufacturers must comply with FDA GMP quality standards in manufacturing the drug.
4. Compliance with the Registration and Drug listing process:
Since Hand Sanitizers are considered as OTC drugs, the manufacturer must comply with drug establishment registration and drug listing process.
5. Banned Ingredients or Contaminants:
There are certain ingredients that the FDA has banned in manufacturing hand sanitizers. The list of ingredients can be found at https://www.fdahelp.us/fda-registration-hand-sanitiszer.html .
6. Enforcement and Recalls:
The FDA will issue recalls for hand sanitizers that do not comply with regulations, especially if they are found to be contaminated or ineffective. They also monitor the market for false or misleading claims (e.g., claiming to kill 100% of germs or other unproven health claims).
Liberty Management Group provides assistance with drug establishment registration, drug listing and label review and US agent service to foreign drug companies.
Sudha S
Regulatory Consultant
Email : office@libertymanagement.us