AQUA MARIS EAR- sodium chloride spray

Aqua Maris Ear by

Drug Labeling and Warnings

Aqua Maris Ear by is a Otc medication manufactured, distributed, or labeled by JGL North America LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

• 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

DOSAGE & ADMINISTRATION

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

INGREDIENTS AND APPEARANCE

AQUA MARIS EAR 
sodium chloride spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76260-104
Route of Administration	AURICULAR (OTIC)

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37)	SODIUM CHLORIDE	11.25 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76260-104-30	1 in 1 CARTON
1		30 mL in 1 BOTTLE, SPRAY

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved drug other		10/29/2009

Labeler - JGL North America LLC (968070503)