AQUA MARIS EAR- sodium chloride spray 
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 Ear

Drug Facts

Active ingredient
Purified Sea Water 		Purpose
Moisturizes and cleanses ear canal

Uses

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

Directions

  • 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

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

  • 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

Ear Spray

AQUA® MARIS

Ear hygiene
Isotonized

30 mle

Carton
AQUA MARIS EAR 
sodium chloride spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76260-104
Route of AdministrationAURICULAR (OTIC)
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:76260-104-301 in 1 CARTON10/29/200902/22/2023
130 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 other10/29/200902/22/2023
Labeler - JGL North America LLC (968070503)
Establishment
NameAddressID/FEIBusiness Operations
JGL d. d.631240835analysis(76260-104) , manufacture(76260-104) , pack(76260-104)

Revised: 2/2023
Document Id: f546bbbf-a2e3-21f9-e053-2a95a90a1016
Set id: 467bad22-2fd7-4009-907e-165168607882
Version: 2
Effective Time: 20230222
 
JGL North America LLC