Hand Sanitizer Health Canada Monograph

The licence holder must notify Health Canada of this intent. 11 rows To date there are no hand sanitizers in Canada approved with COVID-19 related claims.

Health Canada S New Rules Make Things Easier For Hand Sanitizer Providers Help Center Icc Compliance Center Inc Usa

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.

Hand sanitizer health canada monograph. Alcohol-based sanitizers the typical type of hand sanitizer are regulated by Health Canada under the Natural Health Products Regulations NHPR. 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. These sanitizers contain either ethanol found in beverage alcohol which is why distilleries and breweries are capable of making it or isopropanol found in rubbing alcohol.

When water is not readily available a hand sanitizer may be a suitable alternative. Authorized hand sanitizers have an eight-digit Drug Identification Number DIN or Natural Product Number NPN on the label and are listed on the List of Hand Sanitizers Authorized by Health Canada. 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 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. 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. Products licensed through a monograph are generally for personal use only.

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. These products are. Companies interested in manufacturing packaging or labelling alcohol-based hand sanitizers need to apply for and receive a product authorization resulting in the issuance of a Natural Product Number NPN and a site licence.

Rubs are leave-on products or hand sanitizers as well as antiseptic wipes. The process outlined in this document specifically applies to Canadian manufacturers of hand sanitizers during the COVID-19 response. Authorized hard-surface disinfectants will have an eight-digit DIN on the label and are listed on the List of Disinfectants for Use Against COVID-19.

According to Health Canada the monograph can be used to support the safety and efficacy of alcohol-based hand sanitizers with a final concentration of 60-80 ethanol or 60-75 isopropanol. Further details are provided herein including labelling rules. 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.

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. 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. TENTATIVE FINAL MONOGRAPH A hand sanitizer may be marketed without obtaining FDA premarket approval if the product is formulated labeled and marketed according to the Tentative Final Monograph for a hand sanitizer.

An Over-the-Counter OTC Drug Monograph is similar to a drug recipe which details the active ingredients drug labeling and sometimes additional testing or manufacturing. 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. 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.

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