AQUA MARIS BABY Drug Facts

Aqua Maris Baby by

Drug Labeling and Warnings

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

Drug Details [pdf]

AQUA MARIS BABY- sodium chloride liquid 
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 BABY

Drug Facts

Active ingredient(s)
Sodium chloride, 9.0 mg/ml (seawater derived)

Purpose
Rinses and cleanses nasal passages

Use

For maintaining daily hygiene of the nasal cavity and rinsing away germs and impurities from baby's nose.

DIRECTIONS

  • Spray in each nostril, several times a day (2-6 times), and more often if necessary.
  • Due to its gentle nature, the product is also suitable for everyday use to help maintain clear nasal passages (drug free, non-habit forming, non-addictive).

WARNINGS

  • For nasal use only.
  • To avoid contamination, do not touch any surfaces with the dispenser tip.
  • Keep out of reach and sight of children.

WHEN USING THIS PRODUCT

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

OTHER INFORMATION

Sealed for your protection. Do not use if safety seal is broken or missing.
Do not expose to temperaturs exceeding 50°C/122°F.
Do not use the product after the expiry date.

INACTIVE INGREDIENT

Purified Water.


Questions or Comments?

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PRINCIPAL DISPLAY PANEL - 50 ML

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PRINCIPAL DISPLAY PANEL - 150 ML

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AQUA MARIS BABY 
sodium chloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 82640-1558
Route of AdministrationNASAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM CHLORIDE9 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 82640-1558-11 in 1 CARTON05/04/202204/04/2023
150 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 finalpart34905/04/202204/04/2023
AQUA MARIS BABY 
sodium chloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 82640-1639
Route of AdministrationNASAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM CHLORIDE9 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 82640-1639-11 in 1 CARTON12/20/202204/04/2023
1150 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 finalpart34912/20/202204/04/2023
Labeler - JGL d. d. (631240835)
Establishment
NameAddressID/FEIBusiness Operations
JGL d. d.631240835manufacture(82640-1558, 82640-1639)

Revised: 4/2023

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