ATHOMER BABY- nasal decongestant 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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Athomer Baby Sterile Isotonic Sea Water Spray

Active Ingredient(s)

Sodium Chloride (0.9%)

Purpose

Nasal Decongestant

Use

Directions

apply 1 to 2 sprayings in each nostril every day

Warnings

Keep out of reach of children

Other information

Inactive ingredients

Sea Water

Package Label - Principal Display Panel

100 ml NDC: 80897-002-10

Inner bottle label outer package label

ATHOMER BABY 
nasal decongestant spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80897-002
Route of AdministrationNASAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE0.9 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80897-002-101 in 1 CARTON11/05/2020
1100 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 other11/05/2020
Labeler - Nobu Baby LLC (090064974)
Establishment
NameAddressID/FEIBusiness Operations
STERGIOULAS, STYLIANOS, & CO. E.E. "PHARMACOSMETIC - DIAFARM"499700727manufacture(80897-002)

Revised: 1/2023
Document Id: f1f0dfad-8398-0bee-e053-2a95a90a3202
Set id: b34ec508-cee1-740c-e053-2995a90ad2cb
Version: 3
Effective Time: 20230110
 
Nobu Baby LLC