NARIXOL
Spray

CE class I medical device.
Slightly hypertonic stable solution containing mannitol and glycerol useful in mechanical cleaning and by osmotic mechanism of the heart. Its use facilitates the removal of obstructions from dirt or external agents of the external nostrils thanks to the direct mechanical action of the solution with the nebulizer and also to the subsequent momentary recall of local tissue water capable of soaking the obstruction or dirt and facilitating its removal. In fact, it allows to eliminate dirt and secondary external crusts due to previous infections, bad nasal hygiene or particular deep cleaning of the nose in a delicate and effective way, it can be used after some time after surgery. This osmotic action is mainly carried out by mannitol.
The formulation allows to eliminate the adhesions and frictions present between the disporco areas and the duct, facilitating the removal or unraveling of the crusts in a simple, non-invasive and non-aggressive way. It also helps remove any potentially irritating foreign bodies.
It assists the restoration of the normal effective useful light of the nostrils. The action of the device is achieved by mechanical and adsorption action as the solution reduces friction by favoring the flow of dirt from the areas reached by the solution jet and soaks the hard crusts, even the external ones, favoring their removal with a simple mechanical action.
There is no pharmacological aid for achieving the function of the device, and the ingredients that compose it do not perform pharmacological actions. For this action glycerol is the functional ingredient. Narixol solution then reduces the irritation of the areas to be treated thanks to the presence of beta-glucan and sodium hyaluronate, which in addition to carrying out the gliding and sliding action act locally as anti-reddening. The natural derivative of esculetin, on the other hand, generally improves the tone and tone of the irrigated areas.

Physical - chemical characteristics
The characterizing parameters are shown in the table.

tq T% (L max) 1.025 - 1.050 Completely water dispersible

Parameter	UM	Standard values REF
Appearance		Aqueous liquid with a characteristic sweetish odor
COLOR	Transparent	Specific weight	g / ml at 20 ° C
pH 1%	Udi pH at 20 ° C	4.0 - 5.0
pH 10%	PH U at 20 ° C	5.0 - 5.3	Solubility

Field and method of use
Narixol solution reduces redness and promotes cleaning of the nostrils with an anti-edema effect through osmosis. Useful in case of nasal obstructions, mechanical cleaning by nebulization in case of turbinates hypertrophy. It can be used in case of edema associated with inflammatory states and in nasal prophylaxis and post-surgical cleaning, after the healing time and restoration of the abnormal nasal respiratory function. It is used as an emollient washing solution in case of dirt from exudates, dirt or crusts.

Instructions for Use
Apply 2-4 sprays per nostril twice a day or as directed by the doctor.

Mechanism of action
The solution acts in the early stages through the mechanical action of the spray, then reducing the friction between the parts of dirt to be eliminated and the nostrils, facilitating their physiological descent thanks to the osmotic recall of water, and then soaking and softening any other small residues up to allow the normal exit with the liquid called by osmosis.

Storage and stability
Store the product at room temperature in a dry place.
The original sealed package is valid for at least 36 months.
Carefully close the dispenser with the special cap after use.

Toxicity
Narixol solution at the concentrations of use and correctly used is not toxic. From the available data, skin absorption is negligible for this class of preparations and none of the ingredients used reaches concentration values close to the risk threshold for the available LD 50. No ingredient is registered in the CMR List or is used in concentration beyond the legal limit allowed for LEAVE-ON products or to be applied on mucous membranes.
The product should not be ingested directly, in all cases the product, even if ingested, is not toxic. The product must not be used on damaged skin. None of the ingredients are classified as CMR or otherwise toxic or harmful for humans or reproduction. The preservatives used are allowed for the intended use within the legal limits.

Quality check
The raw materials used, the packaging and the intermediate processing phases and of each single production lot are controlled through an internal standard procedure (POS) system.
All suppliers of raw materials and packaging are ISO 9000 - EN46000 CERTIFIED.
Each production batch is microbiologically and chemically checked in an authorized and accredited external laboratory for the analyzes performed.

Components
100 g of solution contain: mannitol FU; glycerol FU; sodium hyaluronate sol 2%; beta-glucan; polysorbate 20; potassium sorbate; sodium benzoate; sodium methyl esculetin; purified water; aroma.

Format
20 ml bottle.