Otc - Active Ingredient
Sodium Chloride (NaCl) 3.0%
Nasocalm Spray
FDA Label NDC 85436-003
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 85436-003). 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
Relieves severe nasal congestion caused by colds, flu, or sinusitis.
Gently moisturizes and soothes nasal passages, providing additional moisture for dry nasal cavities.
Clears nasal passages and reduces swelling caused by sinus congestion.
Suitable for daily nasal hygiene for individuals with chronic nasal congestion or sinus issues.
Used for nasal irrigation in patients with chronic rhinitis, allergic rhinitis, nasal polyps, sinusitis, and other nasal conditions.
Ideal for post-surgical nasal care or nasal cleansing after chemotherapy, helping to clear nasal passages.
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
Otc - Do Not Use
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 - Stop Use
If irritation or discomfort occurs, stop use and consult a doctor
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.
