Active Ingredients:
Sodium Chloride 0.65%
Vortex Moisturizer Nasal
FDA Label NDC 82529-000
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Vortex Life Sciences, Inc. for the product Vortex Moisturizer Nasal (NDC 82529-000). 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 active ingredients:, purpose:, inactive ingredient:, uses, directions:, warning:, if pregnant or breastfeeding,, stop use and consult with a physician, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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:
Label (Label)
* Please review the disclaimer below.
