SPL v1
SPL
SPL Set ID 3165de94-3b77-844b-e063-6394a90a7a7a
Route
NASAL
Published
Effective Date 2025-03-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Sodium Cation (90 mg) Bicarbonate Ion (10 mg)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-03-28

Description

Sodium Chloride (NaCl): 4.05 g Sodium Bicarbonate (NaHCO₃): 0.45 g


Medication Information

Warnings and Precautions

Warnings

1. For nasal rinse only. Do not ingest.

2. Use only sterile, distilled, or previously boiled and cooled water to avoid infections

Indications and Usage

1.Helps clear nasal passages and sinuses by flushing out allergens, mucus, and irritants.

2.Relieves nasal congestion due to colds, flu, allergies, and sinusitis.

3.Suitable for daily nasal irrigation and post-surgical nasal care.

Dosage and Administration

Directions

1. Prepare the Solution: Mix one packet with 500 mL (16.91 FL OZ) of sterile or previously boiled and cooled water. Stir until fully dissolved.

2. Perform Nasal Rinse: Lean over a sink, tilt your head slightly, and gently squeeze or pour the solution into one nostril while breathing through your mouth. Allow the solution to drain from the other nostril. Repeat on the other side.

3. After Use: Blow your nose gently to remove excess fluid. Wash your irrigation device thoroughly and let it air dry.

4. Children and infants must be used under adult supervision. For children under 5 years old, please follow the advice of a healthcare professional.

Description

Sodium Chloride (NaCl): 4.05 g Sodium Bicarbonate (NaHCO₃): 0.45 g

Section 44425-7

Store in a cool, dry place.

Keep the packets sealed until use.

Section 50565-1

Keep out of reach of children.

Section 50566-9

Discontinue use if nasal irritation, nosebleeds, or persistent discomfort occurs.

Section 51945-4

Section 55105-1

Nasal Irrigation & Congestion Relief

Section 55106-9

Sodium Chloride (NaCl): 4.05 g

Sodium Bicarbonate (NaHCO₃): 0.45 g


Structured Label Content

Indications and Usage (34067-9)

1.Helps clear nasal passages and sinuses by flushing out allergens, mucus, and irritants.

2.Relieves nasal congestion due to colds, flu, allergies, and sinusitis.

3.Suitable for daily nasal irrigation and post-surgical nasal care.

Dosage and Administration (34068-7)

Directions

1. Prepare the Solution: Mix one packet with 500 mL (16.91 FL OZ) of sterile or previously boiled and cooled water. Stir until fully dissolved.

2. Perform Nasal Rinse: Lean over a sink, tilt your head slightly, and gently squeeze or pour the solution into one nostril while breathing through your mouth. Allow the solution to drain from the other nostril. Repeat on the other side.

3. After Use: Blow your nose gently to remove excess fluid. Wash your irrigation device thoroughly and let it air dry.

4. Children and infants must be used under adult supervision. For children under 5 years old, please follow the advice of a healthcare professional.

Warnings and Precautions (34071-1)

Warnings

1. For nasal rinse only. Do not ingest.

2. Use only sterile, distilled, or previously boiled and cooled water to avoid infections

Section 44425-7 (44425-7)

Store in a cool, dry place.

Keep the packets sealed until use.

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50566-9 (50566-9)

Discontinue use if nasal irritation, nosebleeds, or persistent discomfort occurs.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Nasal Irrigation & Congestion Relief

Section 55106-9 (55106-9)

Sodium Chloride (NaCl): 4.05 g

Sodium Bicarbonate (NaHCO₃): 0.45 g


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)