Public Summary

Summary for ARTG Entry: 170556 Aaron Laboratories Pty Ltd - Hospital Grade Disinfectant, 'Ethanol', 'Ortho Phenylphenol', with Claims, Non
Sterile

ARTG entry for Other Therapeutic Good - Registered disinfectant

Sponsor Aaron Laboratories Pty Ltd

Postal Address 21 Kitchen Road, DANDENONG, VIC, 3175
Australia
ARTG Start Date 15/04/2010
Product Category Other Therapeutic Good
Status Active
Approval Area Medical Devices

Conditions

- The inclusion of the kind of device in the ARTG is subject to compliance with all conditions placed or imposed on the ARTG entry. Refer Part 4-5, Division 2
(Conditions) of the Therapeutic Goods Act 1989 and Part 5, Division 5.2 (Conditions) of the Therapeutic Goods (Medical Devices) Regulations 2002 for
relevant information.
- Breaching conditions of the inclusion related to the device of the kind may lead to suspension or cancellation of the ARTG entry; may be a criminal offence;
and civil penalties may apply.

Products

1 . Strike Surface Spray Hospital Grade Disinfectant Citrus Fresh

Public Summary
Product Type Single Device Product Effective Date 3/08/2018 9:33:13 AM

GMDN 9950 Disinfectant, hospital grade

Intended Purpose An aerosol surface spray disinfectant for household use to kill bacteria and viruses on hard surfaces

Specific Conditions

Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods under
Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.
Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered or
Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.
Pursuant to Section 28(2B) of the Therapeutic Goods Act 1989, I have decided to impose "The registration number must be placed on the label of the
device by writing the number, immediately preceded by "AUST R" so that it is clearly visible to the user on (i) the label of the device; or (ii) the label on the
outermost level of packaging in which the device is to be supplied to the user."
Stability testing to be performed on the first two production batches, which will include an appropriate microbial efficacy test at the end of the closed shelf
life.

2 . Strike Surface Spray Hospital Grade Disinfectant Eucalyptus

Product Type Single Device Product Effective Date 3/08/2018 9:33:10 AM

GMDN 9950 Disinfectant, hospital grade

Intended Purpose An aerosol surface spray disinfectant for household use to kill bacteria and viruses on hard surfaces

Specific Conditions

Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods under
Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.
Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered or
Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.
Pursuant to Section 28(2B) of the Therapeutic Goods Act 1989, I have decided to impose "The registration number must be placed on the label of the
device by writing the number, immediately preceded by "AUST R" so that it is clearly visible to the user on (i) the label of the device; or (ii) the label on the
outermost level of packaging in which the device is to be supplied to the user."
Stability testing to be performed on the first two production batches, which will include an appropriate microbial efficacy test at the end of the closed shelf
life.

3 . Strike Surface Spray Hospital Grade Disinfectant Marine

Product Type Single Device Product Effective Date 3/08/2018 9:33:13 AM

GMDN 9950 Disinfectant, hospital grade

Intended Purpose An aerosol surface spray disinfectant for household use to kill bacteria and viruses on hard surfaces

Specific Conditions

Page 1 of 2 Produced at 15.08.2020 at 10:59:51 AEST

This is not an ARTG Certificate document.
The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.
Visit www.tga.gov.au for contact information
 Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods under
Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.
Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered or
Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.
Pursuant to Section 28(2B) of the Therapeutic Goods Act 1989, I have decided to impose "The registration number must be placed on the label of the
device by writing the number, immediately preceded by "AUST R" so that it is clearly visible to the user on (i) the label of the device; or (ii) the label on the
outermost level of packaging in which the device is to be supplied to the user."
Stability testing to be performed on the first two production batches, which will include an appropriate microbial efficacy test at the end of the closed shelf
life.

© Commonwealth of Australia. This work is copyright. You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior
written approval from the Commonwealth. Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 2 of 2 Produced at 15.08.2020 at 10:59:51 AEST

This is not an ARTG Certificate document.
The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.
Visit www.tga.gov.au for contact information