INCARVEXX ESSENTIAL- sodium chloride, iodine spray

Incarvexx Essential by

Drug Labeling and Warnings

Incarvexx Essential 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]

ACTIVE INGREDIENT

lodine (0.002%)

Sodium Chloride (0.9%)

PURPOSE

lodine (0.002%) Antiseptic

Sodium Chloride (0.9%) Nasal Decongestant

Uses

• For clearing the nasal cavities 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 a prevention use once a day with 2 sprayings

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

Warnings

* Use only as directed

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

INACTIVE INGREDIENT

• Sea water

Other information or comments

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

PRINCIPAL DISPLAY PANEL

NDC: 80897-030-35

INGREDIENTS AND APPEARANCE

INCARVEXX ESSENTIAL 
sodium chloride, iodine spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80897-030
Route of Administration	NASAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
IODINE (UNII: 9679TC07X4) (IODINE - UNII:9679TC07X4)	IODINE	20 ug  in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698)	SODIUM CHLORIDE	9 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80897-030-35	1 in 1 CARTON	06/22/2021
1		35 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		06/22/2021

Labeler - Nobu Baby LLC (090064974)

Establishment
Name	Address	ID/FEI	Business Operations
STERGIOULAS, STYLIANOS, & CO. E.E. "PHARMACOSMETIC - DIAFARM"		499700727	manufacture(80897-030)