Applying for a Drug Identification Number (DIN) to distribute or sell hand sanitizer: Eligible products
On this page
Products eligible for monograph licensing stream
Hand sanitizers containing 1 of the following non-prescription drug medicinal ingredients, within the concentrations indicated below, are eligible for a DIN through the Category IV monograph (DINF) stream:
- Benzalkonium chloride (0.1% to 0.15%)
- Benzethonium chloride (0.05% to 0.5%)
- Chlorhexidine gluconate (2% to 4%)
- Chloroxylenol (0.5% to 3%)
- Triclosan (0.1% to 1%)
Products are not eligible for authorization under the monograph if they contain:
- more than 1 medicinal ingredient or
- a concentration outside of the range shown above
Non-medicinal ingredients
All non-medicinal ingredients (NMI) in the product must:
- be listed in the Natural Health Products Ingredients Database (NHPID) with an acceptable non-medicinal purpose and
- meet the limitations outlined in the database
An NMI is any substance that is added to give suitable consistency or form to the medicinal ingredients (suitable as per dosage form and route of administration).
NMIs must be safe. They must not:
- have pharmacological effects
- have any effect that contradicts the product’s recommended purpose
- exceed the minimum concentration required for their non-medicinal purpose
- adversely affect the medicinal ingredients in terms of:
- bioavailability
- pharmacological activity
- safety
- have any antibacterial or antiseptic properties
- if found to have antibacterial or antiseptic properties, the application will be rejected and the application fee will be forfeited
- if you are unsure if an NMI in your product has antibacterial or antiseptic properties, you can request advice before filing an application by contacting Health Canada at nnhpd.consultation-dpsnso@hc-sc.gc.ca
Monograph requirements
Monographs are developed for drugs with a well-characterized safety and efficacy profile under specific conditions of use. Therefore, evidence to support safety, efficacy, and quality of the product are not needed, as long as these products meet all parameters of the monograph:
- ingredient
- concentration
- claims
- conditions of use, including all cautions and warnings to be listed on the product label
Hand sanitizers must meet the quality requirements specified in the Food and Drug Regulations (FDR) for drugs. An attestation to the monograph also attests to the adherence to the Good Manufacturing Practices (GMP) requirement of the FDR.
Although you do not need to submit chemistry and manufacturing data to Health Canada, it is important to keep all pertinent information on file, including:
- specifications for the product
- stability data to support the shelf life
Note that the monograph includes claims only for personal domestic use. No additional claims outside the monograph are permitted, such as:
- antiviral efficacy
- claims specific to COVID-19/SARS-CoV-2
- claims specific to any other virus, bacteria or fungi
- claims to kill 99.9% pathogens
This monograph does not apply to:
- antiseptic products for use in commercial or institutional settings, such as hospitals or medical clinics
- these products must meet the requirements in the Guidance Document – Human-Use Antiseptic Drugs
- personal use antiseptic products for wound cleansing
- products for use on parts of the body other than the hands
For information on the filing requirements for products outside the monograph, please contact the NNHPD at nnhpd.consultation-dpsnso@hc-sc.gc.ca.