Product Code: MCS-0010

TECHNICAL DATA SHEET (TDS)

Product Name:          Med-Cover® Barrier Film

Category:                     Medical Device

Class:                             Class 1- other

(Non-sterile and without measurement function)

1.       General Product Description

Med-Cover Barrier Film is 100% silicone based. It forms a long-lasting transparent barrier layer which can dry in a maximum of 35-45 seconds. This transparent barrier layer is long lasting, breathable, durable and provides full protection against potential damage. The plaster, ostomy adapter, which will be used after the product is applied, does not prevent wound care products from adhering. It is neither toxic nor irritating.

2.       Instruction for Use

1. Visually inspect the bottle of Med-Cover Barrier Film for damage prior to opening. Do not use damaged
2. Skin should be clean and dry prior to application of Barrier
3. Hold the spray nozzle 10-15 cm (4-6 inches) away from the skin and apply While moving the spray in a wide motion, ensure that the entire application point is covered with film. If there is an area that is overlooked, have the product reapplied to that area.
4. Reapplication of the barrier film is required with each dressing and/or In cases where it is not possible to apply to the skin, the medical adhesive can be applied on and easily removed.
5. When used as a protectant against body fluids, feces, or urine and no adhesive products are applied to skin it is recommended to reapply the barrier film every 24-72 hours depending on situation.
6. More frequent application may be necessary in applications that require frequent cleaning (e.g., defecation with constant diarrhea).
7. Close the cover of the product when not in

3.       Presentations:

Med Cover Barrier Film product is presented in a tube of 30 ml and 50ml. A detailed product list is given in the table below.

4.       Ingredients

5. General Appearance: Liquid, Transparent
6. Shelf life: 3 years
7. Primary packaging: High Density Polyethylene