AQUA MARIS FAST ACTING DECONGESTANT- xylometazoline hcl spray
JGL North America LLC

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®

Fast Acting Decongestant

Xylometazoline HCl 0.1%

Drug Facts

Active ingredients
Xylometazoline HCl 0.1%

Purpose
Nasal Decongestant

Uses

Temporarily relieves nasal congestion for up to 10 hours due to cold, hay fever, and upper respiratory allergies. Relieves symptoms of nasal discomfort caused by dryness and sinus pressure.

Warnings

Ask a doctor before use if you have

heart disease
high blood pressure
thyroid disease
diabetes
difficulty urinating due to an enlarged prostate gland

If pregnant or breastfeeding, ask a health professional before use.

Keep out of reach of children.

If swallowed, get medical help or contact Poison Control Center right away.

When using this product

Do not use more than directed
Do not use for more than 3 days. Use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen
Temporary discomfort such as burning, stinging, sneezing, or an increase in nasal discharge may occur
Wipe nozzle after each use. The use of this dispenser by more than one person may spread infection

Stop use and ask a doctor if symptoms persist.

Directions

Adults and children 12 years of age or over: 2 or 3 sprays into each nostril not more often than every 8 to 10 hours
Do not use more than 3 doses in 24 hours
Do not give to children under 12 years of age unless directed by a doctor.

To spray, hold bottle with thumb at base and nozzle between first and second fingers. Without tilting head, insert nozzle into nostril. Fully depress pump all the way down with a firm even stroke and sniff deeply. Wipe nozzle clean after use.

Other information

Store between 68° and 77° F (20° - 25° C)

Inactive Ingredients

purified seawater, potassium dihydrogen phosphate

Question or comments?

1-888-353-AQUA

PRINCIPAL DISPLAY PANEL

NASAL DECONGESTANT

AQUA®
MARIS
Fast Acting
Decongestant

Xylometazoline HCl 0.1%

xylometazoline HCl 0.1%
+ purified seawater

0.33 fl oz (10 ml)

AQUA MARIS FAST ACTING DECONGESTANT
xylometazoline hcl spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:76260-106
Route of Administration	NASAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
XYLOMETAZOLINE HYDROCHLORIDE (UNII: X5S84033NZ) (XYLOMETAZOLINE - UNII:WPY40FTH8K)	XYLOMETAZOLINE HYDROCHLORIDE	10 mg in 10 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
POTASSIUM PHOSPHATE, MONOBASIC (UNII: 4J9FJ0HL51)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:76260-106-30	1 in 1 CARTON	12/15/2012	02/22/2023
1		10 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	12/15/2012	02/22/2023

Labeler - JGL North America LLC (968070503)

Name	Address	ID/FEI	Business Operations
Establishment
JGL d. d.		631240835	analysis(76260-106) , manufacture(76260-106) , pack(76260-106)

Revised: 2/2023

Document Id: f546cdc7-d34a-9bef-e053-2995a90aa745

Set id: b70ba985-2894-493f-a4cf-c9102fe36d97

Version: 2

Effective Time: 20230222

JGL North America LLC

AQUA MARIS® Fast Acting Decongestant Xylometazoline HCl 0.1%