AQUA MARIS STRONG Drug Facts

Aqua Maris Strong by

Drug Labeling and Warnings

Aqua Maris 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 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 STRONG

Drug Facts

Active ingredient(s)
Sodium chloride, 36 mg/ml (seawater derived)

Purpose
Nasal wash

Use

It is recommended in cases of a congested nose and breathing difficulties due to allergies, colds and flu

WARNINGS

• For nasal use only.
• 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, supports the physiological condition of the mucosa and has no systemic effects (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.

No special storage conditions.

Do not use the product after the expiry date.

INACTIVE INGREDIENT

Purified Water.

Questions or Comments?

00 385 51 546 399

PRINCIPAL DISPLAY PANEL

Aqua Maris Strong Nasal Spray 30mL - NDC: 82640-1640-1 -Label

Aqua Maris Strong Nasal Spray 30mL - NDC: 82640-1640-1 -Container Label

Aqua Maris Strong Nasal Spray 30mL - NDC: 82640-1640-1 -Carton Label

AQUA MARIS STRONG 
sodium chloride spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82640-1640
Route of Administration	NASAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37)	SODIUM CHLORIDE	36 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: 82640-1640-1	1 in 1 CARTON	12/22/2022	07/11/2023
1		30 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(82640-1640) , manufacture(82640-1640) , pack(82640-1640)

Revised: 7/2023

Document Id: 00304cae-efa7-dafb-e063-6294a90a6579

34390-5

Set id: 1f6375f8-48d0-4084-bfaf-fbbcd9e4f8e5

Version: 4

Effective Time: 20230711