Compress

Main information

  • Trade name:
  • Compress, hot pack, chemical
  • Class:
  • Class IIa
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Compress, hot pack, chemical
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 220680
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

220680

Reckitt Benckiser Pty Ltd - Compress, hot pack, chemical

ARTG entry for

Medical Device Included Class IIa

Sponsor

Reckitt Benckiser Pty Ltd

Postal Address

PO Box 20097 World Square,Sydney, NSW, 2002

Australia

ARTG Start Date

4/03/2014

Product category

Medical Device Class IIa

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.

Manufacturers

Name

Address

Reckitt Benckiser Pty Ltd

44 Wharf Road

WEST RYDE, NSW, 2114

Australia

Products

1. Compress, hot pack, chemical

Product Type

Procedure Pack

Effective date

4/03/2014

GMDN

37697 Compress, hot pack, chemical

Intended purpose

A procedure pack consisting of Nurofen Gel (AUST R 79909) and Nurofen Heat Pack (ARTG 182074).

The gel is indicated for temporary relief of pain and inflammation associated with acute soft tissue injuries

including sprains, strains and sports injuries. The heat pack is indicated for effective pain relief of back and

muscle pain - targets the pain by soothing muscle relaxing heat.

Specific Conditions

No Specific Conditions included on Record

© 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 1 of

Produced at 10.11.2017 at 03:27:03 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.

Visit www.tga.gov.au for contact information