Active Ingredient(s)

Sodium Chloride (0.9%)

Purpose

Nasal decongestant

Use

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

Directions

For the liquidation and removal of the unpleasant mucus, apply at least 4 sprayings in each nostril up to 4 times per day
For preventative daily use, apply 1 to 2 sprayings in each nostril every day
Suitable for repeated long-term use
Shake well before each use

Warnings

Use only as directed
The use of this dispenser by more than one person may spread infection
If you are pregnant or breastfeeding, seek guidance from a healthcare professional

Keep out of reach of children.

Other information or comments

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

Inactive ingredients

Purified Water, Propolis

Package Label - Principal Display Panel

35 ml NDC: 80897-001-35

Inner bottle label outer package label

100 ml NDC: 80897-001-10

Inner bottle label baby outer package label baby

ATHOMER PROPOLIS
nasal decongestant spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:80897-001
Route of Administration	NASAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698)	SODIUM CHLORIDE	0.9 mg in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
PROPOLIS WAX (UNII: 6Y8XYV2NOF)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:80897-001-35	35 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	11/04/2020
2	NDC:80897-001-10	100 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	11/04/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		03/30/2020

Labeler - Nobu Baby LLC (090064974)

Name	Address	ID/FEI	Business Operations
Establishment
STERGIOULAS, STYLIANOS, & CO. E.E. "PHARMACOSMETIC - DIAFARM"		499700727	manufacture(80897-001)