AQUA MARIS EXTRA STRONG Drug Facts

Aqua Maris Extra Strong by

Drug Labeling and Warnings

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

Drug Details [pdf]

AQUA MARIS EXTRA STRONG- 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 EXTRA STRONG

Drug Facts

Active ingredient(s)
Sodium chloride, 2.1% (seawater derived)

Purpose
Nasal wash

Use

Aqua Maris ®Extra Strong:

- removes inhaled impurities (dust, dirt) and irritans (bacteria, viruses, allergens)

- reduces the swelling of the mucosa

- improves breathing through the nose.

WARNINGS

• For nasal use only.
• To avoid contamination, any surfaces with the dispenser tip.
• Keep out of reach and sight of children.

DIRECTIONS

• 1-2 sprays in each nostril, several times a day (2-6 times), and more often if necessary.
• It can be used by itself or in combination with other therapies (drug-free, non habit-forming, non-addictive).

WHEN USING THIS PRODUCT

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

OTHER INFORMATION

Sealed for your protection. Do not use if safety seal is broken or missing.
Do not expose to temperatures exceeding 50°C/122°F.
Do not use the product after the expiry date.

INACTIVE INGREDIENT

Purified Water.

Questions or Comments?

00 385 51 546 399

PRINCIPAL DISPLAY PANEL - 50 ML

PRINCIPAL DISPLAY PANEL - 150 ML

AQUA MARIS EXTRA STRONG 
sodium chloride spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82640-1638
Route of Administration	NASAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37)	SODIUM CHLORIDE	21 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: 82640-1638-1	1 in 1 CARTON	12/22/2022	07/11/2023
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	12/22/2022	07/11/2023

AQUA MARIS EXTRA STRONG 
sodium chloride spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82640-1637
Route of Administration	NASAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37)	SODIUM CHLORIDE	21 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: 82640-1637-1	1 in 1 CARTON	12/22/2022	07/11/2023
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	12/22/2022	07/11/2023

Labeler - JGL d. d. (631240835)

Establishment
Name	Address	ID/FEI	Business Operations
JGL d. d.		631240835	analysis(82640-1638, 82640-1637) , manufacture(82640-1638, 82640-1637) , pack(82640-1638, 82640-1637)

Revised: 7/2023

Document Id: 0030108d-9c21-d304-e063-6394a90a5ce5

34390-5

Set id: 1fc98fab-b978-4c28-b783-a63e4514e9f1

Version: 3

Effective Time: 20230711