Incarvexx Essential Seawater Nasal Spray

Incarvexx Essential Seawater by

Drug Labeling and Warnings

Incarvexx Essential Seawater by is a Otc medication manufactured, distributed, or labeled by Nobu Baby LLC, STERGIOULAS, STYLIANOS, & CO. E.E. "PHARMACOSMETIC - DIAFARM". Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

INCARVEXX ESSENTIAL SEAWATER- nasal decongestant spray 
Nobu Baby LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Incarvexx Essential Seawater Nasal Spray

Active Ingredient(s)

Iodine (0.02 %) Purpose Antiseptic

Sodium Chloride (0.9%) Purpose Nasal Decongestant

Purpose

Antiseptic, Aasal Decongestant

Use

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

Directions

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

Warnings

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

Keep out of reach of children.

Other information

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

Inactive ingredients

Sea water

Package Label - Principal Display Panel

35 ml NDC: 80897-003-35

Inner bottle label outer package label

INCARVEXX ESSENTIAL SEAWATER 
nasal decongestant spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 80897-003
Route of AdministrationNASAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IODINE (UNII: 9679TC07X4) (IODINE - UNII:9679TC07X4) IODINE0.9 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM CHLORIDE (UNII: 451W47IQ8X) 1.45 mg  in 100 mL
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 80897-003-351 in 1 CARTON03/30/202003/30/2020
135 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/30/202003/30/2020
Labeler - Nobu Baby LLC (090064974)
Establishment
NameAddressID/FEIBusiness Operations
STERGIOULAS, STYLIANOS, & CO. E.E. "PHARMACOSMETIC - DIAFARM"499700727manufacture(80897-003)

Revised: 6/2021
Document Id: c4f67abe-a1a6-14c3-e053-2a95a90a02d0
Set id: b34fa5a9-672c-0606-e053-2995a90a3466
Version: 2
Effective Time: 20210617
 
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