Aqua Maris Baby

Manufacturer
JGL North America LLC
Effective date
2011-12-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:49:49

Label at a glance#

ProductAqua Maris Baby
Active ingredientSODIUM CHLORIDE
Label structure8 sections

Indications and uses

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

Dosage and administration

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

Storage and handling

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

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient
Purified Sea Water
Purpose
Moisturizes and cleanses nasal passages

Uses

INDICATIONS & USAGE SECTION

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

Directions

OTC - WHEN USING SECTION

  • 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

WARNINGS SECTION

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

OTC - PURPOSE SECTION

  • Use only as directed
  • The use of this dispenser by more than one person may spread infection.

Other information

STORAGE AND HANDLING SECTION

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

Inactive Ingredient

INACTIVE INGREDIENT SECTION

Purified Water

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NASAL DROPS


AQUA®
MARIS

baby

Isotonised
Adriatic

15 mle

Carton
Carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76260-103-152023-02-22C16284748780-197449f38-ccf8-f6ea-e053-dbdaa90aa703Aqua Maris Baby Drug Facts
76260-103-152019-11-13C16284748780-197449f38-ccf8-f6ea-e053-dbdaa90aa703Aqua Maris Baby Drug Facts

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
SODIUM CHLORIDEACTIVE INGREDIENT451W47IQ8X1
SODIUM CATIONACTIVE MOIETYLYR4M0NH371
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76260-10376260-103-15

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM CHLORIDE451W47IQ8XACTIB
WATER059QF0KO0RIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
f546c681-71bb-1030-e053-2995a90a1dd5eca045d7-e921-49ec-af67-2d4f68d717ae2023-02-22WarningsExact identifier
spl set id: eca045d7-e921-49ec-af67-2d4f68d717ae

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.