Warnings
For nasal use only. Not for injections.
Do not share to avoid cross-contamination.
To avoid contamination, please use the product as soon as possible after opening.
Nasocalm Spray
FDA Label NDC 85436-001
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 (NDC 85436-001). 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 warnings, otc - purpose, otc - active ingredient, indications & usage, otc - do not 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
Hydrates, soothes, and clears nasal passages, relieves mild congestion, and flushes out allergens, dust, and pollutants, suitable for daily nasal hygiene for all ages.
Otc - Active Ingredient
Sodium Chloride (NaCl) 0.9%
Indications & Usage
Gently hydrates and soothes dry nasal passages.
Flushes out allergens, dust, and airborne pollutants.
Relieves mild nasal congestion caused by colds, flu, allergies, or dry environments.
Ideal for daily nasal hygiene, suitable for infants, pregnant women, and all ages.
Also used for nasal irrigation in patients with acute and chronic rhinitis, allergic rhinitis, nasal polyps, sinusitis, and other nasal diseases.
For use after rhinitis surgery or chemotherapy to help clear nasal passages.
Otc - Do Not Use
If irritation or discomfort occurs, discontinue use and consult a doctor.
Do not use if packaging is damaged or solution appears cloudy.
Not for use by individuals with large nasal cavity wounds.
Not for use by individuals with severe sodium chloride metabolic disorders or allergies.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Dosage & Administration
Directions
1. Shake the bottle gently before use.
2. Adults & Children (6+ years): Spray 1-2 times per nostril, up to 6 times daily.
3. Infants & Young Children (under 6 years): Use 1 spray per nostril, up to 4 times daily, or as directed by a healthcare professional.
4. To apply, gently tilt head forward, insert nozzle into nostril, and press the pump while inhaling lightly.
5. Wipe the nozzle after use and close the cap securely.
6. 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
1. Store at room temperature (15-30°C or 59-86°F).
2. Protect from extreme heat and direct sunlight.
Inactive Ingredient
Purified water USP
* Please review the disclaimer below.
