VORTEX MOISTURIZER ORAL- phenol spray

Vortex Moisturizer Oral by

Drug Labeling and Warnings

Vortex Moisturizer Oral by is a Otc medication manufactured, distributed, or labeled by Vortex Life Sciences, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients:

Phenol 0.7%

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.

Keep out of reach of children.

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:

INGREDIENTS AND APPEARANCE

VORTEX MOISTURIZER ORAL 
phenol spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82529-001
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PHENOL (UNII: 339NCG44TV) (PHENOL - UNII:339NCG44TV)	PHENOL	7 mg  in 1 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82529-001-01	1 in 1 BOX	03/01/2022
1		15 mL 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 not final	part356	03/01/2022

Labeler - Vortex Life Sciences, Inc. (118489121)