INCARVEXX ESSENTIAL- sodium chloride, iodine spray 
Nobu Baby LLC

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Incarvexx Essential Nasal Spray

lodine (0.002%)

Sodium Chloride (0.9%)

lodine (0.002%) Antiseptic

Sodium Chloride (0.9%) Nasal Decongestant

Uses

Directions

* Apply 1-4 sprayings into each nostril up to 4 times a day

* As a prevention use once a day with 2 sprayings

Keep out of reach of children

Warnings

* Use only as directed

* The use of the dispenser by more than 1 person may spread infection

Other information or comments

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

NDC: 80897-030-35

Outer package label

bottle label

INCARVEXX ESSENTIAL 
sodium chloride, iodine spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80897-030
Route of AdministrationNASAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IODINE (UNII: 9679TC07X4) (IODINE - UNII:9679TC07X4) IODINE20 ug  in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE9 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80897-030-351 in 1 CARTON06/22/2021
135 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other06/22/2021
Labeler - Nobu Baby LLC (090064974)
Establishment
NameAddressID/FEIBusiness Operations
STERGIOULAS, STYLIANOS, & CO. E.E. "PHARMACOSMETIC - DIAFARM"499700727manufacture(80897-030)

Revised: 1/2023
Document Id: f1f0be1e-39c3-a6d4-e053-2a95a90af0b6
Set id: c55e3b82-f8d9-1934-e053-2995a90a7511
Version: 2
Effective Time: 20230110
 
Nobu Baby LLC