Reckitt Benckiser (Australia) - Scholl cushion foot device and Scholl Hydrogel dressing, non sterile

Therapeutic Goods Act 1989

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

I, Dr Jane Cook, Office Head, Office of Product Review, Therapeutic Goods Administration and delegate of the Secretary to the Department of Health and Ageing, on receipt of an application by Reckitt Benckiser (Australia) Pty Limited, have approved under section 42DF (1) 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 products identified in paragraph (b):

1. "Diabetes" when used solely in the context of the cautionary statement: "Please SEEK ADVICE before using this product if you are diabetic or have poor blood circulation, as your foot condition may require treatment by a healthcare professional" accompanied by the alert box "Scholl and diabetes".
2. Scholl Cushion foot device (ARTG Number 199332) and Scholl Hydrogel dressing, non sterile (ARTG Number 198671).

Dated this 24 day of September 2012

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