Description
A medical device for the treatment of ulcerative or traumatic skin lesions that facilitates the healing process by creating a microenvironment favorable to microcirculation activation and, at the same time, unfavorable to pathogen proliferation, also exerting a film-forming, protective, and barrier action.
NOVOX comes in the form of an oily gel, contained in a single-dose syringe with a sealed cap, enclosed in a hermetically sealed and indelibly labeled poly-laminated package.
NOVOX, under medical supervision, can be used for the treatment of:
- traumatic wounds (e.g., abrasions and lacerations);
- superficial, medium, and deep burns;
- vascular and pressure ulcers;
- fistulas and unhealed surgical wounds.

Instructions for use
The use of NOVOX is primarily intended for healthcare personnel with wound care expertise. Its use can be extended to individuals without specific skills, with simple training and periodic supervision by healthcare personnel.

Before applying the device, wash and disinfect hands thoroughly: preferably wear disposable gloves to handle the device.
The NOVOX medical device can be used alone or in conjunction with non-adherent secondary dressings, or other dressings as per physician's judgment.
Any infection of the lesion does not constitute a contraindication to the use of the NOVOX device.
For skin lesions, wounds, sores, and ulcers:
- before applying the device, clean the lesion area with saline solution, sterile water, or other appropriate solution.
- immediately before using the device, remove the cap from the syringe by pulling firmly and twisting slightly to facilitate unlocking the cap;
- apply the device to the lesion to obtain a uniform thickness of a few millimeters (2-4 mm), preferably extending beyond the lesion area;
- cover with a non-adherent secondary dressing capable of maintaining moisture. In the case of particularly exudative wounds, it is recommended to cover the NOVOX layer with an absorbent dressing;
- remove the device by irrigating with saline solution when clinically indicated (e.g., fluid leakage, excessive bleeding, suspected infection, etc.). If removal of the secondary dressing proves difficult, it should be completely saturated with saline solution or sterile water and slowly removed;
- the device can be applied 2-3 times a week for a maximum of 30 days. It is advisable to reduce the frequency of applications as the healing process completes.
In the case of extended lesions, use more than one single-dose (syringe).

Components
Oxygen-enriched olive oil.
Excipients: natural pear fragrance.

The device may contain traces (<0.4%) of the following allergens: citral, geraniol, citronellol, linalool, limonene.

Warnings
Do not use after the expiry date.
Single-dose product, once the package is opened and even partially used, do not store it for subsequent reuse: in case of reuse, the risk of reinfection of the lesion cannot be excluded.
Do not use the product to treat more than one patient: in case of use on multiple patients, the transmission of pathogens cannot be excluded.
Do not use the product if the package is open or damaged.
Do not use in conjunction with topical medications.
A slight burning sensation upon application may be normal; it generally disappears a few seconds after application.
In case of intense or persistent irritating phenomena, discontinue use and inform your doctor or paramedic.
In case of accidental ingestion, consult a doctor and show them the label.
Keep out of reach of children.
In case of use on minors, adult supervision is recommended.
If further information is needed, please contact the manufacturer.
NOVOX should not be used in individuals with known hypersensitivity or who have had an allergic reaction to the device or its components.

Storage
Store at a temperature below 25 °C.
Shelf life in unopened packaging: 24 months.

Format
1 single-use 5 ml syringe.

Code. NS005S