Vortex Moisturizer Oral Spray

Manufacturer
Vortex Life Sciences, Inc.
Effective date
2022-03-07
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:48:37

Label at a glance#

ProductVortex Moisturizer Oral
Active ingredientPHENOL
Label structure7 sections

Indications and uses

Relieves dry, sore and irritated throat

Dosage and administration

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 ho...

Label contents#

Full prescribing information#

Active Ingredients:

OTC - ACTIVE INGREDIENT SECTION

Phenol 0.7%

Purpose:

OTC - PURPOSE SECTION

Anesthetic/Analgesic

Inactive Ingredient:

INACTIVE INGREDIENT SECTION

Purified mineral water

Uses

INDICATIONS & USAGE SECTION

Relieves dry, sore and irritated throat

Directions:

DOSAGE & ADMINISTRATION SECTION

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:

WARNINGS SECTION

Use only as directed.

If pregnant or breastfeeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

consult with a physician before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Stop use and consult with a physician

OTC - STOP USE SECTION

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

SPL UNCLASSIFIED SECTION

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:

SPL UNCLASSIFIED SECTION

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

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label2Label2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2595234phenol 0.7 % Mucosal SprayPSN1
2595234phenol 7 MG/ML Mucosal SpraySCD1
2595234phenol 0.7 % Mucosal SpraySY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
82529-001-012024-01-30C16284748780-11030e365-1729-111a-e063-dadaa90a10e2Vortex Moisturizer Oral Spray

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82529-001-01Vortex Moisturizer Oral15 mL in 1 BOTTLESPRAY151
82529-001-01Vortex Moisturizer Oral1 in 1 BOXSPRAY11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82529-001VORTEX MOISTURIZER ORAL (PHENOL) SPRAY [VORTEX LIFE SCIENCES, INC.]1Legacy NDC, 2 package rows20220308_d9a1909d-1fc1-c4c8-e053-2995a90a89b8.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82529-00182529-001-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
PHENOL339NCG44TVACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
d9a190fb-3023-2383-e053-2995a90aec30d9a1909d-1fc1-c4c8-e053-2995a90a89b82022-03-07WarningsExact identifier
spl id: d9a190fb-3023-2383-e053-2995a90aec30
spl set id: d9a1909d-1fc1-c4c8-e053-2995a90a89b8

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.