NASOCALM- sodium chloride spray

Nasocalm by

Drug Labeling and Warnings

Nasocalm by is a Otc medication manufactured, distributed, or labeled by Virexion Health Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

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.

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.

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.

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

NASOCALM 
sodium chloride spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85436-001
Route of Administration	NASAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37)	SODIUM CHLORIDE	0.9 mg  in 100 mg

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85436-001-01	1 in 1 BOX	03/28/2025
1		100 mg in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	03/28/2025

Labeler - Virexion Health Inc. (243333153)

Establishment
Name	Address	ID/FEI	Business Operations
Virexion Health Inc.		243333153	manufacture(85436-001) , label(85436-001)