Health Canada Hand Sanitizer Monograph

Usually monograph products are for personal use only. The following antisepticantibacterial skin cleansers or hand sanitizers meet Health Canadas requirements and are authorized for sale in Canada.

Cdc70hsg Hand Sanitizer Gel

If all requirements have been met a product licence including a Natural Product Number NPN for your product will be issued.

Health canada hand sanitizer monograph. These products are required to have a Drug Identification Number DIN or Natural Product Number NPN before entering the marketplace. Compendium of Monographs - Guidance Document This document outlines and describes what a monograph is and how it can be used in a product application for natural health products sold in Canada. Through an active Internet connection the web PLA form searches and populates data from the Natural Health Products Ingredients Database NHPID.

Similarly to the United States Canada also uses monographs to describe the requirements that topical antiseptics and wound cleaners must meet before being offered for sale and use. Products licensed through a monograph are generally for personal use only. Key Locations for Hand Sanitizer.

The monograph supports the safety and efficacy of alcohol-based hand sanitizers with a final concentration of 60 to 80 ethanol or 60 to 75 isopropanol isopropyl alcohol. Health Canada has got to be notifying of this aim by email before distribution. Formulation for a 10-Litre Preparation Ethanol 96.

Further details are provided herein including labelling rules. However given the COVID-19 pandemic alcohol-based hand sanitizers are often distributed to be used in hospitals clinics commercial settings and other acceptable facilities. Due to shortages of hand sanitizers caused by the COVID-19 pandemic Health Canada has guidance on the use of both ethanol and isopropanol in hand sanitizers.

While Health Canadas monograph stipulates a range of 60-80 vv ethanol an 80 vv concentration is recommended for increased efficacy. Applications made against Health Canadas monograph and provided electronically through ePost will be reviewed in an expedited manner within 24 hours dependent on application volume. Class I personal protective equipment such as masks and gowns and swabs are regulated as medical devices in Canada.

A non-prescription drug Category IV Monograph outlines the permissible conditions of use and labelling requirements such as dose intended use directions for use warnings active ingredients and combinations thereof. The Human-Use Antiseptic Drugs HUAD guidance document applies to professional and commercial use antiseptic skin products as well as non-monograph personal use products such as those making viral specific organisms persistence andor log reduction claims. Although they have not been tested for effectiveness against viruses such as coronaviruses hand sanitizers can help reduce the risk of infection by or spread of.

These new rules apply to products that meet Health Canadas Antiseptic Skin Cleaners Personal Domestic Use monograph which lays out known safety and effectiveness data for standard concentrations of ethanol and isopropanol cleaners so suppliers dont have to provide data on products already well-known to be safe. Ad Bsafe Hand Sanitiser Foam for Children Adults. Recommended handrub formulations 2010 provides a recipe for the preparation of a hand sanitizer with a final concentration of 80 vv ethanol.

Hand sanitizers are classified as natural health products NHPs or non-prescription drugs depending on the ingredients. Health Canada has developed Monographs for Disinfectant Drugs that outlines the permitted active ingredients and concentrations target microorganism classes contact times and associated use areas for these products to be licensed without the submission of additional evidence to Health Canada. In Canada disinfectants are classified as non-prescription drugs.

Sterling Hand Sanitizer follows the Health Canada Antiseptic Skin Cleansers Domestic Personal Use Monograph and is made in accordance with the WHO World Health Organization formulation. Web PLA version 4 with class I monograph validation Access version 4 of the form for all application and class types if you are not attesting to a monograph or if the monographs you are attesting to appears on the list of Validation-supported. The licence holder must notify Health Canada of this intent.

ONLY SITE LICENCE REQUIRED. Eliminate Germs Bacteria. Sterling Hand Sanitizer follows the Health Canada Antiseptic Skin Cleansers Domestic Personal Use Monograph and is made in accordance with the WHO World Health Organization formulation.

The database provides information on acceptable medicinal and non-medicinal ingredients standard terminology and single ingredient and product monographs. Given the COVID-19 pandemic and as part of this interim measure alcohol-based hand sanitizers can be distributed for use in hospitals clinics commercial settings and other acceptable facilities. To date there are no hand sanitizers in Canada approved with COVID-19 related claims.

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