Reckitt Benckiser (Australia) - Hydrogel dressing, non-sterile

Therapeutic Goods Act 1989

Approval under section 42DF for use of restricted representations by Reckitt Benckiser (Australia) Pty Limited

I, Dr Jane Cook, Head, Office of Product Review, Therapeutic Goods Administration and delegate of the Secretary to the Department of Health, on receipt of an application from Reckitt Benckiser (Australia) Pty Limited, have approved under section 42DF of the Therapeutic Goods Act 1989 (the Act) the restricted representation described in paragraph (a) below for use on the label and in advertisements directed to consumers, for the product identified in paragraph (b):

1. This product is not suitable for diabetics or those with poor blood circulation (or words of like intent).
2. Hydrogel dressing, non-sterile (ARTG Number 198671)

Dated this 10 day of September 2014

Dr Jane Cook
Delegate of the Secretary to the Department of Health; and
Head
Office of Product Review