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Scholls Wellness Company Pty Ltd - Travel socks (ARTG 462107); Bunion cushions (ARTG 462106); Wound hydrogel dressing, sterile (ARTG 462673); Cryogenic spray, cutaneous (ARTG 447270); Cryogenic spray, cutaneous (ARTG 431870)

Therapeutic Goods Act 1989

Approval under section 42DF for use of restricted representations by Scholls Wellness Company Pty Ltd

I, Rowena Love, as a delegate of the Secretary to the Department of Health and Aged Care, on receipt of an application from Scholls Wellness Company Pty Ltd, have approved under section 42DF of the Therapeutic Goods Act 1989, the restricted representations described in Paragraphs 1, 2, 3, 4 and 5, for use in advertisements for the products identified in paragraph 1.a, 2.a, 3.a, 4.a and 5.a, respectively (including on the label and packaging of the goods).

Approved representations

  1. ‘Diabetes’ when used solely in the context of the cautionary statements:
    • “Scholl and diabetes”; and
    • “People with diabetes should consult a healthcare professional before use”
    1. “Travel Socks” (ARTG 462107)
  2. ‘Diabetes’ when used solely in the context of the cautionary statements”
    • “If you have diabetes, poor blood circulation or loss of feeling in the feet, consult a healthcare professional before use”.
    1. “Bunion Cushions - Shield, bunion” (ARTG 462106)
  3. ‘Diabetes’ when used solely in the context of Open Blisters, cuts, and Grazes and the statements:
    • “People with diabetes should consult a healthcare professional before use”
    1. Wound hydrogel dressing, sterile (ARTG 462673)
  4. ‘Diabetes’ when used solely in the context of the statements:
    • “Scholl and diabetes”; and
    • “Do not use Scholl’s Freeze Away Max if you have diabetes, poor blood circulation, or a condition that weakens your immune system. Do not use if you are pregnant or breastfeeding”.
    1. Scholl Freeze Away MAX Verruca & Wart Remover - Cryogenic spray, cutaneous (ARTG 447270)
  5. ‘Diabetes’ when used solely in the context of the cautionary statement:
    • Do not use if you are diabetic.
    1. Scholl Freeze Away Skin Tag Remover - Cryogenic spray, cutaneous (ARTG 431870)

Dated this 22nd day of January 2025

Signed electronically

Rowena Love 

Delegate of the Secretary to the Department of Health and Aged Care
Advertising and Compliance Education and Policy Section
Regulatory Compliance Branch

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