OTOSOL
drops

CE class I medical device.
Stable oily dispersion of natural and semi-synthetic ingredients able to promote cleaning of the external auditory canal facilitating the restoration of general conditions in case of external ear and ear canal infections. In fact, it allows to eliminate dirt and secondary external crusts due to previous infections, poor otological hygiene or special deep cleaning of the external ear canal in a delicate and effective way.
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. The action of the device is achieved by mechanical and adsorption action as the solution reduces friction by favoring the flow of dirt in the deep areas and soaks hard crusts, even the external ones, then facilitating 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.
Otosol solution is not indicated for the treatment or prophylaxis of otological infections or for the treatment of otitis. The direct action, on the other hand, of reduction of redness and irritation is obtained thanks to glycerin. of the patient's discomfort.

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

Appearance 0.995 - 1.000 PH U at 20 ° C pH 10% 5.0 - 5.3 Solubility

Parameter	UM	Standard values REF
	Oily liquid with characteristic odor of oregano OE
COLORtq	T% (L max)	Opaque-whitish
Specific weight	g / ml at 20 ° C
pH 1%	4.0 - 5.0
PH U at 20 ° C
	Water dispersible

Field and method of use
Otosol solution reduces redness and promotes cleaning of the external auditory canal through mechanical and adsorption action, it is used in clinical-clinical practice to reduce otological cleaning times and to facilitate it by contributing to the reduction of friction, flaking and disintegration of crusts and waxy masses in the outer ear area. It is used as an emollient washing solution in case of dirt from exudates, ear wax or scabs. Useful in case of eczema, mycosis and dermatitis.

Instructions for Use
Apply 2-4 drops twice a day or as directed by your doctor.

Mechanism of action
The solution acts by reducing the friction between the parts of dirt occluding to be eliminated and the external auditory canal and also with a disintegrating effect on the hardest cerose-crusted parts. In this sense, the ingredients effectively soften the residues which can then be quickly removed, even naturally with the natural movement of the posture.

Storage and stability
Store the product at room temperature in a dry place.
The original sealed package is valid for at least 36 months.
Close the bottle carefully with the appropriate dropper after use.

Toxicity
Otosol 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 concentrations beyond the legal limit allowed for LEAVE-ON products.
The product should not be ingested or used on damaged skin. None of the ingredients are classified as CMR or in any case toxic or harmful to 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: propylene glycol FU; glycerol FU; unsaponifiable olive oil (Olea Europea); acetic acid; climbazole; essential oil of oregano; purified water.

Format
20 ml bottle.