AQUA MARIS BABY- sodium chloride liquid 
JGL North America 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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Aqua Maris Baby

Drug Facts

Active ingredient
Purified Sea Water 		Purpose
Moisturizes and cleanses nasal passages

Uses

For moisturizing and maintenance of daily hygiene of the nasal cavity. Suitable for repeated long-term use

Directions

  • For daily maintenance of nasal hygiene, apply one drop of Aqua Maris Baby into each nostril while the baby is in the lying position
  • To soften and remove larger amounts of impurities or secretions from the nasal cavity, apply several drops of Aqua Maris Baby into each nostril. Repeat the procedure as necessary

Warnings

For external use only, do not inject.

Do not use

  • if solution changes color or becomes cloudy
  • Do not use if seal is broken or missing

When using this product

  • 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 between 59° and 77° F (15° to 25°C)

Inactive Ingredient

Purified Water

PRINCIPAL DISPLAY PANEL

NASAL DROPS


AQUA®
MARIS
baby

Isotonised
Adriatic

15 mle

Carton
AQUA MARIS BABY 
sodium chloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76260-103
Route of AdministrationNASAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM CHLORIDE11.25 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76260-103-151 in 1 CARTON07/08/201002/22/2023
115 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 other07/08/201002/22/2023
Labeler - JGL North America LLC (968070503)
Establishment
NameAddressID/FEIBusiness Operations
JGL d. d.631240835analysis(76260-103) , manufacture(76260-103) , pack(76260-103)

Revised: 2/2023
Document Id: f546c681-71bb-1030-e053-2995a90a1dd5
Set id: eca045d7-e921-49ec-af67-2d4f68d717ae
Version: 2
Effective Time: 20230222
 
JGL North America LLC