Vortex Moisturizer Nasal 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 Nasal
Active ingredientSODIUM CHLORIDE
Label structure7 sections

Indications and uses

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

Dosage and administration

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, mini...

Label contents#

Full prescribing information#

Active Ingredients:

OTC - ACTIVE INGREDIENT SECTION

Sodium Chloride 0.65%

Purpose:

OTC - PURPOSE SECTION

Moisturizer

Inactive Ingredient:

INACTIVE INGREDIENT SECTION

Purified mineral water

Uses

INDICATIONS & USAGE SECTION

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

Directions:

DOSAGE & ADMINISTRATION SECTION

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:

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.

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

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
707251sodium chloride 0.65 % Nasal SprayPSN1
707251sodium chloride 6.5 MG/ML Nasal SpraySCD1
707251NaCl 6.5 MG/ML Nasal SpraySY1
707251sodium chloride 0.65 % Nasal SpraySY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
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e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
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b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
82529-000-012024-01-30C16284748780-11030e365-522b-111a-e063-dadaa90a10e2Vortex Moisturizer Nasal Spray

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82529-000-01Vortex Moisturizer Nasal15 mL in 1 BOTTLELIQUID151
82529-000-01Vortex Moisturizer Nasal1 in 1 BOXLIQUID11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82529-000VORTEX MOISTURIZER NASAL (SODIUM CHLORIDE) LIQUID [VORTEX LIFE SCIENCES, INC.]1Legacy NDC, 2 package rows20220308_d87f20d6-933f-4419-b035-e307a13a60aa.zip

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82529-00082529-000-01

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
SODIUM CHLORIDE451W47IQ8XACTIB

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
d9a1828b-0288-0a20-e053-2a95a90a4838d87f20d6-933f-4419-b035-e307a13a60aa2022-03-07WarningsExact identifier
spl id: d9a1828b-0288-0a20-e053-2a95a90a4838
spl set id: d87f20d6-933f-4419-b035-e307a13a60aa

Reported adverse events (FAERS/openFDA)#

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