FDA.reportPublic FDA data

Aqua Maris Strong

Manufacturer
JGL d. d.
Effective date
2023-07-11
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 21:28:58

Label at a glance#

ProductAqua Maris Strong
Active ingredientSODIUM CHLORIDE
Label structure9 sections

Dosage and administration

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).

Storage and handling

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.

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

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

OTC - PURPOSE SECTION

Purpose
Nasal wash

Use

INDICATIONS & USAGE SECTION

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

WARNINGS

WARNINGS SECTION

  • 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

DOSAGE & ADMINISTRATION SECTION

  • 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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

OTHER INFORMATION

STORAGE AND HANDLING SECTION

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

INACTIVE INGREDIENT SECTION

Purified Water.


Questions or Comments?

00 385 51 546 399

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

Aqua Maris Strong Nasal SprayAqua Maris Strong Nasal Spray

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

Aqua Maris Strong Nasal SprayAqua Maris Strong Nasal Spray

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

Aqua Maris Strong Nasal SprayAqua Maris Strong Nasal Spray

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82640-164082640-1640-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
SODIUM CHLORIDE451W47IQ8XACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
00304cae-efa7-dafb-e063-6294a90a65791f6375f8-48d0-4084-bfaf-fbbcd9e4f8e52023-07-11WarningsExact identifier
spl id: 00304cae-efa7-dafb-e063-6294a90a6579
spl set id: 1f6375f8-48d0-4084-bfaf-fbbcd9e4f8e5

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.