In March 2020, the TGA released a Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19). This legislation (Therapeutic Goods (Excluded Goods—Hand Sanitisers) Determination 2020 Version F2020L00340) exempts the inclusion of hand sanitisers in the Australian Register of Therapeutic Goods (ARTG) if they meet specified formulation, manufacturing, labelling and advertising requirements set out in this instrument.
Precise Defend complies with this. The final formulation of the Precise Defend Hand Sanitiser contains only permitted ingredients and meets the prescribed concentration of active alcohol.
It is the consensus opinion of the World Health Organisation (WHO) expert group that WHO recommended hand rub formulations can be used for hygienic hand antisepsis.
The microbicidal activity of the Precise Defend WHO-recommended formulation was tested by WHO reference laboratories according to EN standards (EN 1500). Their activity was found to be equivalent to the reference substance (isopropanol 60% v/v) for hygienic hand antisepsis.
Post-production analysis to show the active component Ethanol is present at minimum prescribed concentration is mandatory for every batch.
In response to the unprecedented demand for hand sanitisers with efficacy against viruses as a result of COVID-19 pandemic, the TGA permits sales of a World Health Organization verified liquid hand sanitiser formulation according to the Therapeutic Goods (Excluded Goods—Hand Sanitisers) Determination 2020 Version F2020L00340. This formulation does not allow for the inclusion of stabilisers, so you may see some separation. If this happens shake the product well to recombine it. This does not change the efficacy of the sanitiser.
Hydrogen peroxide is used to inactivate contaminating bacterial spores in the solution and is not included as an active substance for hand antisepsis.