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

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

Aqua Maris Strong Nasal Spray

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

Aqua Maris Strong Nasal Spray

AQUA MARIS STRONG 
sodium chloride spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82640-1640
Route of AdministrationNASAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM CHLORIDE36 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82640-1640-11 in 1 CARTON12/22/2022
130 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34912/22/2022
Labeler - JGL d. d. (631240835)
Establishment
NameAddressID/FEIBusiness Operations
JGL d. d.631240835analysis(82640-1640) , manufacture(82640-1640) , pack(82640-1640)

Revised: 4/2023
Document Id: fa37a7d2-2868-85f4-e053-6394a90a0211
Set id: 1f6375f8-48d0-4084-bfaf-fbbcd9e4f8e5
Version: 3
Effective Time: 20230426
 
JGL d. d.