AQUA MARIS THROAT- sodium chloride spray 
JGL North America LLC

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Aqua Maris Throat

Drug Facts

Active ingredient
Purified Sea Water 		Purpose
Relieves symptoms of sore throat

Uses

  • For alleviation of sore throat and bad breath resulting from blocked nose or salivary gland diseases
  • For maintaining oral hygiene after surgical interventions in the oral cavity, pharynx and after tonsillectomy

Directions

  • Turn the dispenser into the horizontal position
  • Direct the dispenser towards the throat and apply 3-4 dispersions 4-6 times per day
  • The procedure can be repeated as often as required to obtain the desired result

Warnings

  • For external use only, do not inject
  • Do not use if seal is broken or missing

When using this product

  • Use only as directed
  • Avoid contamination, do not touch tip of container to any surface
  • The use of this dispenser by more than one person may spread infection.

Keep out of reach of children

Other information

Store between 59° and 77° F (15° to 25°C)

Inactive Ingredient

Purified Water

PRINCIPAL DISPLAY PANEL

Throat Spray


AQUA®
MARIS
hypertonic

Adriatic
sea water

30 mle

Carton
AQUA MARIS THROAT 
sodium chloride spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76260-105
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM CATION37.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76260-105-301 in 1 CARTON04/20/200502/22/2023
130 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other04/20/200502/22/2023
Labeler - JGL North America LLC (968070503)
Establishment
NameAddressID/FEIBusiness Operations
JGL d. d.631240835analysis(76260-105) , manufacture(76260-105) , pack(76260-105)

Revised: 2/2023
Document Id: f547ffaf-592e-89fe-e053-2995a90af435
Set id: 5d386ab7-f2a7-410f-b6f1-9526361da8d7
Version: 2
Effective Time: 20230222
 
JGL North America LLC