XLEAR NASAL DECONGESTANT- nasal spray liquid

Xlear Nasal Decongestant by

Drug Labeling and Warnings

Xlear Nasal Decongestant by is a Otc medication manufactured, distributed, or labeled by Xlear Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

WARNINGS AND PRECAUTIONS

The use of this container by morethan one person may spread infection. Keep out of reach of children. Clean nozzle after each use and replace the cap. Do not exceed recommended dosage. Do not use this product for more than 3 days. If pregnant or breast-feeding, ask a health professional before use. Ask a physician before use if you have, heart disease, highblood pressure, thyroid disease, diabetes, trouble unitnating due to enlarged prostate gland. Not for children under age 6 unless directed by a physician. 

PURPOSE

Uses: For temporary relief of nasal decongestion due to colds, hay fever or other upper respiratory allergies, or associated with sinusitus. Helps sooth and moisturize nasal passages. thins and loosens mucous secretions.

INDICATIONS & USAGE

Shake well before using. The metered pump sprayer provides a precise amount of soothing spray in a fine mist. Claer the nasal passage-way by gently blowing your nose before using. Prior to initial use, remove cap, prime the pump by holding it upright and pumping one or more times until the solution is dispensed. Insert nozzle into nostirl and depress pump completely while breathing in through the nose. Clean nozzle after use. Ages 6 years to adult (with adult supervision) - spray 1-2 times in each nostril not more often than every 10 to 12 hours. Do not exceed 2 doses in any 24-hour period.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

WARNINGS

The use of this container by more than one person may spread infection. Keep out of reach of children. Clean nozzle after each use and replace the cap. Do not exceed recommended dosage. Do not use this product for more than 3 days. If pregnant or breast-feeding, ask a health professional before use. Ask a physician before use if you have, heart disease, highblood pressure, thyroid disease, diabetes, trouble unitnating due to enlarged prostate gland. Not for children under age 6 unless directed by a physician.

ACTIVE INGREDIENT

Active Ingredients: Oxymetazoline HCL 0.05% .............. nasal decongestant

DOSAGE & ADMINISTRATION

Shake well before using. The metered pump sprayer provides a precise amount of soothing spray in a fine mist. Claer the nasal passage-way by gently blowing your nose before using. Prior to initial use, remove cap, prime the pump by holding it upright and pumping one or more times until the solution is dispensed. Insert nozzle into nostirl and depress pump completely while breathing in through the nose. Clean nozzle after use. Ages 6 years to adult (with adult supervision) - spray 1-2 times in each nostril not more often than every 10 to 12 hours. Do not exceed 2 doses in any 24-hour period.

INACTIVE INGREDIENT

Inactive Ingredients: Benzalkonium Chloride, purified water, xylitol

PRINCIPAL DISPLAY PANEL

The use of this container by more than one person may spread infection. Keep out of reach of children. Clean nozzle after each use and replace the cap. Do not exceed recommended dosage. Do not use this product for more than 3 days. If pregnant or breast-feeding, ask a health professional before use. Ask a physician before use if you have, heart disease, highblood pressure, thyroid disease, diabetes, trouble unitnating due to enlarged prostate gland. Not for children under age 6 unless directed by a physician.

INGREDIENTS AND APPEARANCE

XLEAR NASAL DECONGESTANT 
nasal spray liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 27017-018
Route of Administration	NASAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OXYMETAZOLINE HYDROCHLORIDE (UNII: K89MJ0S5VY) (OXYMETAZOLINE - UNII:8VLN5B44ZY)	OXYMETAZOLINE HYDROCHLORIDE	0.0005 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
XYLITOL (UNII: VCQ006KQ1E)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 27017-018-01	1 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	03/12/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M	03/12/2019

Labeler - Xlear Inc. (839884058)

Registrant - Xlear Inc. (839884058)

Establishment
Name	Address	ID/FEI	Business Operations
Xlear Inc.		839884058	manufacture(27017-018)