Main information

  • Trade name:
  • Nail treatment solution
  • Class:
  • Class 1
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device



  • Available in:
  • Nail treatment solution
  • Language:
  • English

Other information


  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 219480
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:


Reckitt Benckiser Pty Ltd - Nail treatment solution

ARTG entry for

Medical Device Included Class 1


Reckitt Benckiser Pty Ltd

Postal Address

PO Box 20097 World Square,Sydney, NSW, 2002


ARTG Start Date


Product category

Medical Device Class 1



Approval area

Medical Devices


- 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.




Reckitt Benckiser Healthcare (UK) Limited

Dansom Lane

Hull, Yorkshire, HU8 7DS


1. Nail treatment solution

Product Type

Single Device Product

Effective date



47918 Nail treatment solution

Intended purpose

It is intended for the self-treatment of mild fungal infections. The device is intended for use in two phases

including nail debridement where the top layers of the nail are physically removed with the nail file and

application of a liquid treatment for forming a film (barrier) over the nail, softening the nail and maintaining

an inhospitable environment where the fungus find it difficult to survive.

Specific Conditions

No Specific Conditions included on Record

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written approval from the Commonwealth.Further details can be found at

Public Summary

Page 1 of

Produced at 10.11.2017 at 07:25:28 AEDT

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.

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