FDA.reportPublic FDA data

Aqua Maris Classic

Manufacturer
JGL d. d.
Effective date
2022-05-06
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 22:01:39

Label at a glance#

ProductAqua Maris Classic
Active ingredientSODIUM CHLORIDE
Label structure9 sections

Dosage and administration

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).

Storage and handling

No special storage conditions. Do not use the product after the expiry date. Preservative-free saline.

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

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

OTC - PURPOSE SECTION

Purpose
Moisturizes and cleanses nasal passages.

Use

INDICATIONS & USAGE SECTION

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

WARNINGS

WARNINGS SECTION

  • 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

DOSAGE & ADMINISTRATION SECTION

  • 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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • 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

STORAGE AND HANDLING SECTION

No special storage conditions.
Do not use the product after the expiry date.

Preservative-free saline.

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

Purified Water.


Questions or Comments?

00 385 51 546 399

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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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
82640-155982640-1559-1

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
SODIUM CHLORIDE451W47IQ8XACTIB
WATER059QF0KO0RIACT

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
f53327a2-98b1-c42f-e053-2995a90a26436037c685-402a-4d93-80e2-bbe714c7aa572023-02-21WarningsExact identifier
spl set id: 6037c685-402a-4d93-80e2-bbe714c7aa57

Reported adverse events (FAERS/openFDA)#

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