FDA.reportPublic FDA data

Incarvexx Essential Seawater Nasal Spray

Manufacturer
Nobu Baby LLC | STERGIOULAS, STYLIANOS, & CO. E.E. "PHARMACOSMETIC - DIAFARM"
Effective date
2020-11-04
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 23:08:35

Label at a glance#

ProductIncarvexx Essential Seawater
Active ingredientIODINE
Label structure9 sections

Dosage and administration

Apply 1-4 sprayings into each nostril up to 4 times a day As prevention use once a day with 2 sprayings

Storage and handling

Store at room temperature between 68° and 77° F (20° to 25°C)

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Iodine (0.02 %) Purpose Antiseptic

Sodium Chloride (0.9%) Purpose Nasal Decongestant

Purpose

OTC - PURPOSE SECTION

Antiseptic, Aasal Decongestant

Use

INDICATIONS & USAGE SECTION

  • For cleaning the nasal cavity and the removal of the unpleasant mucus
  • For nasal irrigation

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply 1-4 sprayings into each nostril up to 4 times a day
  • As prevention use once a day with 2 sprayings

Warnings

WARNINGS SECTION

  • Use only as directed
  • The use of this dispenser by more than one person may spread infection

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Other information

STORAGE AND HANDLING SECTION

  • Store at room temperature between 68° and 77° F (20° to 25°C)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Sea water

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

35 ml NDC: 80897-003-35

Inner bottle labelInner bottle labelouter package labelouter package label

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80897-00380897-003-35

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM CHLORIDE451W47IQ8XIACT
WATER059QF0KO0RIACT
IODINE9679TC07X4ACTIB

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
c4f67abe-a1a6-14c3-e053-2a95a90a02d0b34fa5a9-672c-0606-e053-2995a90a34662021-06-17WarningsExact identifier
spl set id: b34fa5a9-672c-0606-e053-2995a90a3466

Reported adverse events (FAERS/openFDA)#

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