Otc - Active Ingredient
Sodium Chloride (NaCl) 3.0%
Nasocalm Solution
FDA Label NDC 85436-004
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 85436-004). 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 - do not use, otc - stop use, otc - keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Reduces nasal congestion, clears mucus and allergens, and assists in relieving symptoms of chronic nasal congestion or sinusitis by drawing out excess fluid from swollen nasal tissues.
Indications & Usage
Helps relieve nasal congestion by reducing nasal swelling through osmotic action
Effectively clears thick mucus caused by colds, sinus infections, and allergies
Assists in post-surgical nasal recovery by reducing inflammation
Recommended for individuals with chronic sinusitis, rhinitis, or persistent congestion.
Warnings
For nasal use only. Not for injections.
Otc - Do Not Use
Do not use if the packaging is damaged or the solution appears cloudy.
Otc - Stop Use
Stop use and consult a doctor if irritation or infection occurs.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Dosage & Administration
Directions
1. Tilt your head slightly forward
2. Insert the nozzle into one nostril
3. Gently squeeze the bottle to release the solution
4. After application, gently blow your nose if necessary
5. Repeat in the other nostril
6. Use 2-6 times per day or as needed
7. 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
Package Label.Principal Display Panel
1 (20250331195525 2)
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