Device Dossier

Skin semi-occlusive dressing

Device Dossier for Skin semi-occlusive dressing (Skin semi-occlusive dressing, Class IIa, sponsor Stratpharma). ARTG record, intended purpose, GMDN…

Intended purpose

StrataCTX is intended for the management of dry skin and cutaneous rashes. StrataCTX is a self-drying, non-sticky, transparent gel formulation that lightly bonds to the most superficial damaged skin layer allowing optimal hydration and reducing the skin’s acute inflammatory response. StrataCTX dries to form a protective flexible wound dressing that is gas permeable and waterproof which hydrates and protects dry skin, open wounds, fissures, Medical Adhesive-Related Skin Injuries (MARSI), erythema, infusion reactions and compromised or desquamating skin surfaces, including cutaneous rashes. StrataCTX is suitable for children and people with sensitive skin. StrataCTX may be used on infants, during pregnancy and while breastfeeding. StrataCTX is intended for single patient use.

TGA Public Summary