OTOSAN NASAL WASH – Powder for Saline Nasal Rinse Solution (30 Sachets)

OTOSAN NASAL WASH – Powder for Saline Nasal Rinse Solution (30 Sachets)

OTOSAN NASAL WASH 30 sachet is a medical device supplied as a powder for preparing a saline nasal irrigation solution.

The product cleanses the nasal mucosa by removing excess mucus, allergens, and airborne pollutants. It helps clear the nasal passages, supports mucociliary clearance, and helps limit contamination.

1. Product Information:

• Medical device name: Powder for preparing a saline nasal irrigation solution.
• Model: OTOSAN NASAL WASH 30 sachet.
• Classification: Class B medical device.
• Product form: Powder for preparing a saline nasal irrigation solution.
• Packaging: One box containing 30 sachets.

2. Ingredients:

Each sachet contains:

• Sodium chloride.
• Sodium bicarbonate.
• 10 mg of sodium hyaluronate (0.35%).

3. Description and Mechanism of Action:

OTOSAN NASAL WASH 30 sachet is a medical device supplied as a powder for preparing a saline nasal irrigation solution.

The product cleanses the nasal mucosa by removing:

• Excess mucus.
• Allergens.
• Airborne pollutants.

It also helps clear the nasal passages, supports mucociliary clearance, and helps limit contamination.

4. Intended Use / Indications:

OTOSAN NASAL WASH 30 sachet is useful in the following situations:

• Nasal congestion.
• Allergic rhinitis.
• Acute and chronic sinusitis.
• Before and after surgery.
• Hypertrophic rhinitis during pregnancy. Use in pregnant women with hypertrophic rhinitis is supported by clinical data from a similar medical device.
• Night-time snoring.
• Living or working in dry or polluted environments.

5. Directions for Use:

Preparing the Solution:

1. Wash the bottle thoroughly with warm tap water. Do not use detergents.
2. Use still bottled mineral water or water that has been boiled for at least one minute.
3. Use warm water at a temperature of 35°C–40°C. If the water is too hot, allow it to cool before use.
4. Fill the bottle with 240 mL of water up to the fill line.
5. Dissolve one sachet to prepare a 1.1% solution or two sachets to prepare a 2.2% hypertonic solution.
6. Shake the bottle until the powder has dissolved completely.

Nasal Irrigation Procedure:

1. Tilt the head slightly forward, lean over the sink, and keep the bottle upright.
2. Place the nozzle into one nostril, keeping the mouth open to breathe.
3. Gently squeeze the bottom of the bottle so that the solution flows into one nostril and out through the opposite nostril. Keep the mouth open and breathe through it throughout the procedure.
4. After rinsing, keep the head tilted forward for a few moments.
5. Repeat the procedure on the other side.
6. Gently blow the nose.
7. Wash the bottle again as described in the initial preparation instructions.

Replacement of the bottle every 3 months is recommended.

6. Dosage and Preparation:

One Sachet — 1.1% NaCl:

Nasal irrigation with a solution prepared from one sachet is recommended twice daily, in the morning and evening.

It may be used for more than 30 days for preventive purposes.

The prepared solution is useful for daily nasal hygiene and in the following situations:

• Allergic rhinitis.
• Sinusitis.
• Common colds.
• Post-operative care.
• Night-time snoring.

Two Sachets — 2.2% NaCl:

Nasal irrigation with a hypertonic solution prepared from two sachets is recommended twice daily in cases of:

• Severe nasal congestion.
• Chronic sinusitis.

The duration of use should not exceed 10 days.

7. Target Users and Age-Specific Precautions:

• Individuals aged 6–18 years should use the product under adult supervision.
• Do not use in children under 6 years of age without first consulting a healthcare professional.

8. Use During Pregnancy and Breastfeeding:

To date, no contraindications have been reported for the use of the ingredients in OTOSAN NASAL WASH during pregnancy or breastfeeding.

Consult a healthcare professional before use.

9. Contraindications:

Do not use in cases of known hypersensitivity to any ingredient.

10. Warnings and Precautions:

• Consult a doctor before using OTOSAN NASAL WASH if the nasal passages are completely blocked.
• Consult a doctor before use if you have an ear infection.
• Consult a doctor before use if you have recently undergone surgery.
• Stop nasal irrigation and consult a healthcare professional if discomfort or pain occurs in the nose or ears.
• Never use boiling or excessively hot water for nasal irrigation.
• Do not apply to damaged skin.
• Keep out of the reach of children.
• Mix the product with water only.
• Perform nasal irrigation only with water mixed with OTOSAN NASAL WASH salts.
• Do not use in cases of known hypersensitivity to any ingredient.
• Do not use the product in any manner or for any purpose other than those specified in the instructions for use.
• Individuals aged 6–18 years should use the product under adult supervision.
• Do not use in children under 6 years of age without first consulting a healthcare professional.
• Do not use after the expiry date.
• Do not use bottles other than those supplied by Otosan.
• Consult a doctor before using the product alongside other medicines or medical devices.
• If any adverse effects occur, discontinue use, notify the manufacturer immediately, and consult a doctor.
• If a serious incident occurs, notify the manufacturer and the competent authority in the country where the incident occurred immediately.

11. Possible Adverse Effects:

• The instructions for use do not specifically list possible adverse effects.
• If discomfort or pain occurs in the nose or ears, stop nasal irrigation and consult a doctor.
• If any adverse effects occur, discontinue use, notify the manufacturer immediately, and consult a doctor.

12. Storage:

• Store at room temperature.
• Store in a dry place.
• Keep out of the reach of children.

13. Shelf Life:

• Do not use after the expiry date.
• A specific shelf life has not been identified in the technical file and requires further verification before this information is updated.

14. Packaging:

One box containing 30 sachets.

15. 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.