FDA Label for Vortex Moisturizer Nasal

View Indications, Usage & Precautions

Vortex Moisturizer Nasal Product Label

The following document was submitted to the FDA by the labeler of this product Vortex Life Sciences, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredients:



Sodium Chloride 0.65%


Purpose:



Moisturizer


Inactive Ingredient:



Purified mineral water


Uses



Temporary relief of dry irritated nasal passages
Promotes healthy nasal passages
Clears and invigorates breathing


Directions:



Sniff and inhale deeply while spraying into nostril.
12 years old- adult: 3 sprays in each nostril.
6 - 12 years old: 2 sprays in each nostril.
3 - 6 years old: 1 spray in each nostril.
Children under age 3: 1 spray. Consult a
physician.
To use, remove cap, insert the nozzle into
the nostril and depress the pump completely
while sniffing deeply.
Day 1: every 3 hours, minimum 5 doses/day
Day 2: every 3 hours, minimum 5 doses/day
Day 3: 3 times a day.
Day 4: at bedtime.
Day 5: at bedtime.
Day 6 - 9: skip.
Day 10: Final dose at bedtime.
For moderate to severe symptoms every 3 hours (minimum 5 doses/24 hrs) until symptoms have significantly reduced. Then,
resume at day 3 schedule.


Warning:



Use only as directed.


If Pregnant Or Breastfeeding,



consult with a physician before use.


Stop Use And Consult With A Physician



if you experience any discomfort while using this product.

In case of overdose, get medical help or contact a Poison Control Center at 1-800-222-2222 right away.


Other Information:



Store and use at room temperature Inspect bottle for integrity Do not use if safety seal is broken


Package Labeling:




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