HCP Safety

The safety of Stratamed

There have been no side effects observed with the proper use of Stratamed gel1. It is not absorbed2, so it will not produce systemic side effects, and it is unlikely to produce local side effects.

Stratamed is bacteriostatic and inert.

Stratamed does not lead to secondary side effects such as maceration, rashes, pruritus and infection, and is therefore suitable for children and people with sensitive skin. Stratamed is safe to use on infants, during pregnancy and whilst breastfeeding.

The ingredients in Stratamed have been laboratory tested for human biology compatibility as per ISO 109933 (“Biological evaluation of medical device”).

Stratamed gel is transparent, 100 % odour free, and does not contain fragrances, parabens or alcohol.

1. Sandhofer M, Schauer P. SKINmed 2012; 10:S1–S7
2. Thomas X. et al. “Silicone Film-Forming Technologies for Health Care Applications”, Dow Corning internal publication, literature no. 52-1068A-01
3. ISO 10993-1:2009 describes:
The general principles governing the biological evaluation of medical devices within a risk management process; the general categorization of devices based on the nature and duration of their contact with the body; the evaluation of existing relevant data from all sources; the identification of gaps in the available data set on the basis of a risk analysis; the identification of additional data sets necessary to analyse the biological safety of the medical device; the assessment of the biological safety of the medical device.