Organic Hand Sanitiser - 750mL

Organic Hand Sanitiser - 750mL

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$40.00$30.00


Product Information

Specific formulations excluded from TGA regulation for the duration of the COVID-19 pandemic

On 28 March 2020, specified hand sanitiser formulations were excluded from TGA regulation, as long as they only contain particular ingredients in particular quantities in the final formulation, and comply with certain manufacturing practices, and advertisement and labelling conditions. Provided that the exact formulation and other requirements are followed, this formulation is permitted for use in both healthcare facilities and consumer use.

This exclusion will facilitate the urgent and continued supply of large volumes of hand sanitisers in Australia.

The formulations are based on advice by the World Health Organization and similar decisions by the US Food and Drug Administration. The final formulation of the hand sanitiser must contain only the following ingredients:

  • EITHER ethanol 80% v/v (pharmacopoeial grade or food standard grade) OR isopropyl alcohol 75% v/v (pharmacopoeial grade) in an aqueous solution;
  • sterile distilled water or boiled cold water;
  • glycerol 1.45% v/v (pharmacopoeial grade);
  • hydrogen peroxide 0.125% v/v (pharmacopoeial grade); and
  • does not contain any other active or inactive ingredients, including colours, fragrances or emollients.

There are strict requirements for labelling of these products. Manufacturers must also test the alcohol concentrations of each batch, manufacture under sanitary conditions and maintain production record-keeping. The legislation enabling production of these sanitisers is the Therapeutic Goods (Excluded Goods - Hand Sanitisers) Determination 2020.

The products will continue to be regulated as consumer goods under Australian Consumer Law. Manufacture of this product is not considered compounding.

 

 



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