OTOSAN NASAL SPRAY FORTE

OTOSAN NASAL SPRAY FORTE — NASAL SPRAY FOR ADULTS

2.2% Hypertonic Nasal Spray

Otosan® Nasal Spray Forte is a medical device supplied as a nasal spray solution that helps relieve nasal congestion through a local osmotic mechanism. It helps thin thick mucus and promotes its drainage and removal from the nasal cavity.

For adults and children aged 12 years and older.

Key Features:

• A 2.2% hypertonic solution made from seawater.
• Helps relieve nasal congestion locally.
• Helps thin thick mucus.
• Promotes mucus drainage and removal from the nasal cavity.
• Contains blackcurrant extract, aloe vera extract, and plant essential oils.
• Propellant-free.
• Suitable for adults and children aged 12 years and older.

1. Ingredients:

Otosan® Nasal Spray Forte contains:

• A 2.2% hypertonic solution made from seawater.
• Blackcurrant extract, 0.5% (Ribes Nigrum Fruit Extract).
• Dry aloe vera extract (Aloe Barbadensis Extract).
• Organic lemon essential oil (Citrus Limon (Lemon) Peel Oil).
• Mountain pine essential oil (Pinus Mugo Leaf Oil).
• Organic tea tree essential oil (Melaleuca Alternifolia (Tea Tree) Leaf Oil).
• No propellants.

2. Benefits / Intended Purpose:

Otosan® Nasal Spray Forte is a medical device for nasal decongestion that acts locally through osmosis.

Upon contact with congested nasal mucosa, the hypertonic solution helps draw water out of the mucosa and thin thick mucus, thereby promoting mucus drainage and removal from the nasal cavity.

The product is recommended as a supportive measure for inflammatory conditions of the upper respiratory tract, including:

• Sinusitis.
• Common colds and acute rhinitis.
• Allergic rhinitis.
• Seasonal rhinitis.

3. Target Users:

• Adults and children aged 12 years and older.
• Do not use in children under 12 years of age.

4. Directions for Use:

• Blow the nose before use.
• Spray the solution into each nostril with a quick, firm press, breathing deeply and keeping the head upright during application.
• After spraying, take a deep breath with the mouth closed while gently pressing the opposite nostril with a finger to help distribute the solution evenly over the nasal mucosa.
• After use, rinse the spray nozzle with warm water and dry it with a tissue.

5. Dosage:

• 1–2 sprays into each nostril, up to 4 times daily.
• The product is well tolerated and may be used regularly, but use for more than 15 consecutive days is not recommended.

6. Pack Size:

One carton containing one 30 mL spray bottle.

7. Contraindications:

Do not use the product:

• In children under 12 years of age.
• In individuals with known hypersensitivity to any ingredient.
• In individuals with hypersensitivity to crustaceans and/or molluscs.
• On damaged nasal mucosa.

8. Warnings and Precautions:

• Avoid contact with the eyes.
• Do not swallow.
• Do not use the product in any manner or for any purpose other than those specified in the manufacturer’s instructions.
• Each spray bottle is intended for use by one person only. Sharing may become a source of infection.
• Discontinue use if any adverse effects occur.
• Consult a doctor before using the product alongside other medicines or medical devices.
• Pregnant or breastfeeding women should consult a doctor before use.
• Keep out of the reach of children.
• Do not use after the expiry date.

9. Possible Adverse Effects:

The product contains no vasoconstrictors and acts through the natural properties of its plant extracts and organic essential oils. It is well tolerated and may be used regularly within the recommended duration.

In a small number of cases, the following may occur:

• Nosebleeds (epistaxis).
• Local allergic reactions in individuals hypersensitive to the ingredients.
• A mild stinging sensation in the nose immediately after application.

If any adverse effects other than those listed above occur, discontinue use immediately and consult a doctor.

10. Storage:

• Store at room temperature in a dry place.
• Keep away from direct sunlight and heat sources.
• Permitted storage temperature according to the label: 0°C–35°C.
• Use within 1 month of opening the bottle.
• 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.