Active Ingredients:
Phenol 0.7%
Vortex Moisturizer Oral
FDA Label NDC 82529-001
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 Oral (NDC 82529-001). 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:
Anesthetic/Analgesic
Inactive Ingredient:
Purified mineral water
Uses
Relieves dry, sore and irritated throat
Directions:
12 years old - adult: 3 sprays.
6 - 12 years old: 2 sprays.
3 - 6 years old: 1 spray.
Children under age 3: 1 spray. Consult a
physician.
To use, remove cap, depress the pump
completely to spray directly into mouth
and throat.
Day 1: every 3 hours
Day 2: every 3 hours
Day 3: 3 times a day
Day 4: at bedtime
Day 5: at bedtime
Day 6 - 9: skip
Day 10: at bedtime (final dose)
For moderate to severe symptoms every 3 hours (minimum 5 doses/24hrs) 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.
Sore Throat Warning
Severe or persistent sore throat or sore throat with high fever, headache, nausea and vomiting may be serious. Consult a doctor right away. Consult a doctor before giving to children under 3.
Other Information:
Store and use at room temperature Inspect bottle for integrity Do not use if safety seal is broken
Package Labeling:
Label2 (Label2)
* Please review the disclaimer below.
