FDA.reportPublic FDA data

Aqua Maris Ear

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 01:49:48

Label at a glance#

ProductAqua Maris Ear
Active ingredientSODIUM CHLORIDE
Label structure8 sections

Indications and uses

Softens and naturally removes ear wax Reduces the possibility of blockage and ease ear wax removal

Dosage and administration

insert the dispenser into the ear and lean your head sideways, ensuring inflow of the liquid into the ear Apply 1-2 injections into each earhole 1-2 daily for 10 days, or 2-3 times a week After the application, rub the ear from the outside with paper tissue to remove excess liquid

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 ear canal

Uses

INDICATIONS & USAGE SECTION

  • Softens and naturally removes ear wax
  • Reduces the possibility of blockage and ease ear wax removal

Directions

OTC - WHEN USING SECTION

  • insert the dispenser into the ear and lean your head sideways, ensuring inflow of the liquid into the ear
  • Apply 1-2 injections into each earhole 1-2 daily for 10 days, or 2-3 times a week
  • After the application, rub the ear from the outside with paper tissue to remove excess liquid

Warnings

WARNINGS SECTION

For external use only, do not inject. Do not use

  • if seal is broken or missing
  • in case of ear infection, eardrum perforation, or if there is a foreign body in the ear
  • without consulting physician in case of any type of earache

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

Ear Spray

AQUA® MARIS

Ear hygiene
Isotonized

30 mle

Carton
Carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76260-104-302023-02-22C16284748780-197449f38-bfd8-f6ea-e053-dbdaa90aa703Aqua Maris Ear Drug Facts
76260-104-302019-11-13C16284748780-197449f38-bfd8-f6ea-e053-dbdaa90aa703Aqua Maris Ear 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
76260-10476260-104-30

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
f546bbbf-a2e3-21f9-e053-2a95a90a1016467bad22-2fd7-4009-907e-1651686078822023-02-22WarningsExact identifier
spl set id: 467bad22-2fd7-4009-907e-165168607882

Reported adverse events (FAERS/openFDA)#

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