OTOSAN NASAL SPRAY ISO

OTOSAN NASAL SPRAY ISO — NASAL CLEANSING SPRAY

1. Ingredients:

Seawater and purified water (equivalent to a salt concentration of 9 g/L).

2. Uses:

Recommended for nasal cleansing in newborns (excluding premature infants), children, and adults, particularly in the following situations:

• Nasal congestion, runny nose, sneezing, nasal dryness, and nasal itching.
• Common colds and nasopharyngitis.
• Allergic rhinitis and rhinosinusitis.
• Exposure to irritating environmental conditions.

3. Mechanism of Action:

• The spray contains natural seawater rich in mineral salts and trace elements.
• Its fine mist allows gentle, even distribution over the nasal mucosa.
• A one-way valve helps prevent external contamination and protects the solution.

4. Dosage:

Apply 1–2 sprays into each nostril, 1–3 times daily, as needed.

5. Target Users:

Newborns (excluding premature infants), children, and adults.

6. Directions for Use:

Nasal cleansing in children must be performed by an adult.

• Lay newborns down. Young children may sit or stand.
• Tilt the head to one side, gently insert the nozzle into the nostril, and spray into the nasal passage. Do not inhale the solution.
• Repeat the procedure in the other nostril.
• After spraying, return the head to an upright position without tilting it backwards, allowing mucus to drain out. Then wipe away the mucus or blow the nose.

For newborns: Gently wipe away the mucus. A nasal aspirator may be used if there is excessive nasal discharge.

For young children: Ask the child to blow their nose.

7. Contraindications:

• Do not use in cases of hypersensitivity to seawater.
• Do not use in premature infants.

8. Precautions and Storage:

• After each use, wash the nozzle with hot soapy water. Do not detach the nozzle from its base, as this may damage the mechanism. Rinse thoroughly and dry before storage.
• Pressurised container: may burst if heated. Keep away from heat, hot surfaces, sparks, open flames, and other ignition sources. No smoking. Do not pierce or burn, even after use.
• Protect from sunlight. Do not expose to temperatures exceeding 50°C.
• KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

9. Packaging:

One 100 mL spray bottle.

10. Shelf Life:

36 months from the date of manufacture.

11. Manufacturer, Country of Origin, and Distributor:

• Manufacturer: OTOSAN S.r.l.
  Address: Via degli Scavi, 32 – Forlì, Italy.
• Country of origin: Italy.
• Distributor in Vietnam: VITAONE INTERNATIONAL JOINT STOCK COMPANY
  Registered address: 42 Street 12, Quarter 37, Hiep Binh Ward, Ho Chi Minh City, Vietnam.
  Head office: 42 Street 12, Quarter 37, Hiep Binh Ward, Ho Chi Minh City, Vietnam.
  Telephone: 077 397 2868.