FTPR 71

Isotonic nasal spray
MDR MEDICAL DEVICE CE

PRODUCT REFERENCE FTPR 71

Medical Device (class IIa)
0.9% isotonic saline solution equipped with a nozzle for cleaning the nasal mucosa and lubricating it for children, adolescents and adults. Isotonic nasal spray keeps the nasal mucosa hydrated by helping muco-ciliary transport, facilitating the removal of impurities such as pollen, dust, allergens, pollutants, smoke and excess mucus. Useful in prevention of nasal congestion, rhinitis and sinusitis.

Posology and instructions for use:
1. Remove the protective capsule from the cylinder and insert the dispenser button on the valve, insert the anatomical dispenser very gently into the nostril, pressing gently to dispense the product. At the end of use, clean and dry the dispenser.
2. Nebulization takes place in any position the bottle is held; however, it is advisable to slightly tilt the head to one side and spray for 2 seconds in the nostril of the opposite side (eg head tilted to the right and product sprayed into the left nostril). Repeat the operation in both nostrils.
3. One nostril spray several times a day, as needed.
At the end of use, clean and dry the dispenser.

Warnings:
• Do not take it if you are allergic, intolerant or hypersensitive to any component.
•  The use of the same cylinder by several subjects can facilitate the transmission of infections: a strictly personal use of the product is recommended.
• Keep out of the reach of children.
• Pressure vessel.
• Protect from sunlight and do not expose to a temperature above 50°C.
• Do not use if the cylinder is damaged. Once the product is exhausted, do not pierce or burn the cylinder. Once used, remove the cylinder and the dispenser following the normal rules of urban waste.
• No side effects associated by used the device have been observed. If you notice the appearance of side effects, inform your doctor.
• Expiry date refers to the product in its intact packaging, and properly stored.

Do not use in case the package is not intact.
Store in its original package at room temperature, place away from heat sources and direct sunlight.
The period of validity after the first opening is 30 days.

Any serious incident that has occurred in relation to the device should be reported to the manufacturer and the Competent
Autorithy. In case of any undesired event always seek for medical advice.

Composition: Hyaluronic acid sodium, Purified water, Sodium chloride, Bibasic potassium phosphate E340(ii), Monobasic potassium phosphate E340(i).

Content total SALE: A bag-on-valve cylinder containing 100 ml of solution + 1 dispenser for nasal use.

Others optional information: Daily nose cleaning for adults and children.

Manufacturer: Labomar S.p.A., Via N. Sauro 35/I, Istrana (TV) Italy.

Revision: September 2023.