AQUA MARIS CLEAN Drug Facts

Aqua Maris Clean by

Drug Labeling and Warnings

Aqua Maris Clean by is a Otc medication manufactured, distributed, or labeled by JGL d. d.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

AQUA MARIS CLEAN- sodium chloride spray 
JGL d. d.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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AQUA MARIS CLEAN

Drug Facts

Active ingredient(s)
Sodium chloride, 9.0 mg/ml (seawater derived)

Purpose
Rinses and cleanses nasal passages

Use

For maintaining daily hygiene of the nasal cavity and rinsing away bacteria, viruses and impurities from the nose.

WARNINGS

• For nasal use only.
• Do not use if seal is broken or missing.
• To avoid contamination, do not touch the tip of the dispenser to any surface.
• Keep out of reach and sight of children.

DIRECTIONS

• Spray 1-2 times in each nostril, several times a day (2-6 times), and more often if necessary.
• Due to its gentle nature, the product is also suitable for everyday use to help maintain clear nasal passages (non-habit forming, non-addictive).

WHEN USING THIS PRODUCT

• For hygiene reasons, the product should only be used by one person; do not share it with others.

OTHER INFORMATION

Do not expose to temperaturs exceeding 50°C/122°F.

Do not use the product after the expiry date.

Preservative-free saline.

INACTIVE INGREDIENT

Purified Water.

Questions or Comments?

00 385 51 546 399

PRINCIPAL DISPLAY PANEL - 50 mL

PRINCIPAL DISPLAY PANEL - 150 mL

AQUA MARIS CLEAN 
sodium chloride spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82640-1556
Route of Administration	NASAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37)	SODIUM CHLORIDE	9 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: 82640-1556-1	1 in 1 CARTON	05/05/2022	02/21/2023
1		50 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part349	05/05/2022	02/21/2023

AQUA MARIS CLEAN 
sodium chloride spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82640-1557
Route of Administration	NASAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37)	SODIUM CHLORIDE	9 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: 82640-1557-1	1 in 1 CARTON	05/05/2022	02/21/2023
1		150 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part349	05/05/2022	02/21/2023

Labeler - JGL d. d. (631240835)

Establishment
Name	Address	ID/FEI	Business Operations
JGL d. d.		631240835	manufacture(82640-1556, 82640-1557)

Revised: 2/2023

Document Id: f5332459-906d-028a-e053-2995a90ad500

34390-5

Set id: 10aaac88-3b0e-40e0-9d9f-04fd5e7050b1

Version: 2

Effective Time: 20230221