AQUA MARIS CLASSIC Drug Facts

Aqua Maris Classic by

Drug Labeling and Warnings

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

Drug Details [pdf]

AQUA MARIS CLASSIC- 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 CLASSIC

Drug Facts

Active ingredient(s)
Sodium chloride, 10.5 mg/ml (seawater derived)

Purpose
Moisturizes and cleanses nasal passages.

Use

For moisturizing and maintaining daily hygiene of the nasal cavity and relieving symptoms of dry and irritated 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

• To maintain daily nasal hygiene andcomfort, spray 1 to 2 times in each nostril. This procedure can be repeated several times a day and over a longer period.
• Spray into the nostril as needed.
• The procedure can be repeated as often as required to obtain the desired result (non-habit forming, non-addicting).

WHEN USING THIS PRODUCT

• Use only as directed.
• Before using the product for the first time, remove the cap and press the pump 2 to 3 times to release the air.
• For hygiene reasons, the product should only be used by one person; do not share it with others.

OTHER INFORMATION

No special storage conditions.
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

AQUA MARIS CLASSIC 
sodium chloride spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82640-1559
Route of Administration	NASAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37)	SODIUM CHLORIDE	10.5 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: 82640-1559-1	1 in 1 CARTON	05/06/2022	02/21/2023
1		30 mL in 1 BOTTLE, GLASS; 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	05/06/2022	02/21/2023

Labeler - JGL d. d. (631240835)

Establishment
Name	Address	ID/FEI	Business Operations
JGL d. d.		631240835	manufacture(82640-1559)

Revised: 2/2023

Document Id: f53327a2-98b1-c42f-e053-2995a90a2643

34390-5

Set id: 6037c685-402a-4d93-80e2-bbe714c7aa57

Version: 2

Effective Time: 20230221