Otc - Active Ingredient
Sodium Chloride (NaCl): 4.05 g
Sodium Bicarbonate (NaHCO₃): 0.45 g
Nasocalm Saline Rinse Mix Packets Powder
FDA Label NDC 85436-005
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Virexion Health Inc. for the product Nasocalm Saline Rinse Mix Packets (NDC 85436-005). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - stop use, otc - keep out of reach of children, dosage & administration, storage and handling, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Nasal Irrigation & Congestion Relief
Indications & 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.
Warnings
Warnings
1. For nasal rinse only. Do not ingest.
2. Use only sterile, distilled, or previously boiled and cooled water to avoid infections
Otc - Stop Use
Discontinue use if nasal irritation, nosebleeds, or persistent discomfort occurs.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Dosage & 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.
Storage And Handling
Store in a cool, dry place.
Keep the packets sealed until use.
* Please review the disclaimer below.
