Registration of First Aid Antiseptic Products in Canada

For those wishing to register a first aid antiseptic product in Canada, the monograph is now available on the Health Canada website. Although the consultation period is still ongoing, applicants can make use of the monograph in their applications to the Natural and Non-Prescription Health Products Directorate immediately, for topical minor wound cleansers. Here’s some answers to commonly asked questions about using the monograph system in Canada for approval of natural health products and over-the-counter health products.

What is a monograph?

A monograph is a pre-cleared document that sets out the proper and safe use of a group of products according to Health Canada. Any manufacturer who would like to use the monograph as evidence of safety and efficacy of their product (instead of providing their own evidence) may do so as long as the conditions in the monograph are met.

Which topical cleansers are covered in the First Aid Antiseptic Products monograph?

Any product containing:

– hydrogen peroxide at 3%

– povidone-iodine at 0.5-1.0%

– benzalkonium chloride at 0.1-0.13%

– benzethonium chloride at 0.1-0.2%

Which product claims are allowed for the products?

Applicants can choose from the list of claims provided in the monograph, such as:

– first aid antiseptic

– kills harmful bacteria

– helps to prevent infection in minor cuts and scratches

Where can I find the monograph?

Copy/paste the following link to your browser to find out more.

What’s the advantage of using a monograph?

By using the monographs, applicants can have their over-the-counter products approved for sale in Canada in as little as ten business days.