Stryker Australia Pty Ltd – Skin cleaning wipes (ARTG 519769)

Therapeutic Goods Act 1989

Approval under section 42DF for use of restricted representations by Stryker Australia Pty Ltd

I, Michael Shum, as a delegate of the Secretary to the Department of Health, Disability and Ageing, on receipt of an application from Stryker Australia Pty Ltd, have approved under section 42DF of the Therapeutic Goods Act 1989, the restricted representations described in paragraph (A), for use in advertisements for the product identified in paragraph (B).

(A)

• Comfort Shield Barrier Cream Cloths can be used to clean, treat and protect skin from incontinence related skin irritation
• The Comfort Shield Barrier Cream Cloths can be used to treat and prevent incontinence-associated dermatitis
• Comfort Shield Barrier Cream Cloths clean, treat and protect skin from incontinence related skin irritation
• Comfort Shield Barrier Cream Cloths treat and prevent incontinence-associated dermatitis
• Comfort Shield Barrier Cream Cloths relieves minor skin irritation due to incontinence
• Comfort Shield Barrier Cream Cloths protects from minor irritation associated with incontinence

(B)

• ‘Skin cleaning wipes’ (ARTG 519769).

Dated this 22nd day of January 2026

Signed electronically

Michael Shum
Delegate of the Secretary to the Department of Health, Disability and Ageing
Education Policy and Guidance Section
Regulatory Compliance Branch