BIOEPITHELIA
PLUS CREAM
Description
CE Class IIb Medical Device.
A therapeutic approach for the treatment and care of damaged skin in adults, older people and children: an organic, plant-based product, without antibiotics, corticosteroids, silicones, synthetic polymers, hyaluronic acid or zinc oxide, able to contribute effectively to every single phase leading to the resolution and healing of the lesion. Indicated for the treatment and care of damaged skin: abrasions, blisters, second-degree burns, surgical incisions, skin lacerations, sores, diabetic ulcers, venous and arterial ulcers, radiodermatitis, post-surgical scars. Bioepithelia Plus cream is made in compliance with the requirements of Directive 93/42/EEC and subsequent amendments.
How to use
Clean and disinfect your hands thoroughly or wear sterile disposable gloves before dressing the wound. Remove any dirt or exudate from the lesion, disinfect the area with a disinfectant suitable for damaged skin, e.g. povidone-iodine, then rinse repeatedly with sterile saline solution to completely remove any disinfectant residue and remove any exudate and residue from the haemostatic phase from the lesion. Then apply the Medical Device gently over the whole affected area, in a sufficient quantity to completely cover the lesion and form a protective layer; if the wound is moist or exuding, use a mesh contact dressing to allow the exudate to pass to the secondary dressing, to be repeated morning and evening. Apply Bioepithelia Plus cream three times a day until the problem has completely resolved. The Bioepithelia Plus cream Medical Device can be used in hospital, in private medical practices or at home by the patient; for correct use, follow the instructions for use provided by the Manufacturer and given in this leaflet. For lesions on areas of the body that are difficult for the patient to reach, the device should be applied with the help of a third person who follows the instructions and directions for use in this leaflet in detail.
Components
Aqua, Biogr-6, Coco-Caprylate, Simmondsia Chinensis Oil, Cetearyl Olivate, Sorbitan Olivate, Glycerin, Glyceryl Stearate, Cetyl Alcohol, Butyrospermum Parkii Butter, Squalane, Sodium Benzoate, Potassium Sorbate, Benzyl Alcohol, Dehydroacetic Acid, Commiphora Myrrha Oil, Lonicera Japonica Flower Extract, Lonicera Caprifolium Flower Extract, Lactic Acid, Phytic Acid, Xanthan Gum, Tocopherol.
Warnings
Studies carried out on the product and on a very large number of users have not shown any contraindications to the use of Bioepithelia Plus cream alone or in combination with other oral medicines. No undesirable effects have been reported from the use of Bioepithelia Plus cream in combination with other medical devices or topical medicines. However, for the best efficacy of the product and resolution of the problem, it is recommended not to use Bioepithelia Plus cream in combination with other Medical Devices or other topical medicines. Do not use Bioepithelia Plus cream in case of known hypersensitivity to any of its components. No contraindications are reported for use during pregnancy and breastfeeding. Assisted use of the Medical Device is recommended for people with psychophysical problems or mental disorders who cannot use it independently.
This Medical Device is not sterile. This Medical Device is for external use only. This Medical Device must not be used on the oral mucosa. Use the Medical Device only if the packaging is intact and has not been tampered with. Avoid excessive or improper use of the product. Avoid contact with the eyes and do not swallow the product. Do not leave the pack open. Do not use the Medical Device after the expiry date shown on the pack. Do not use the Medical Device after the period-after-opening shown on the label. Avoid prolonged exposure of the Medical Device to sunlight. Keep the Medical Device out of the reach of children. Keep the Medical Device out of the reach of people with psychophysical and mental disorders. Do not dispose of the container in the environment after use. Bioepithelia Plus cream is normally well tolerated; in case of sensitisation or allergy, stop treatment and inform your doctor or pharmacist. If the symptom persists even after proper use of Bioepithelia Plus cream, consult your doctor or pharmacist.
Storage
Store in a cool, dry place at room temperature (8-25°C), away from heat sources and sunlight.
Shelf life after first opening: 6 months.
Pack size
45 ml bottle.
Code 002
