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

The use of this container by more than one person may spread infection. Keep out of reach of children. Clean nozzle after each use & 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 - high blood pressure - thyroid disease - diabetes - trouble urinating due to enlarged prostate gland - Not for children under age 6 unless directed by a physician.

Uses

Uses: For temporary relief of nasal decongestion due to colds, hay fever or upper respiratory allergies, or associated with sinusitis. Helps soothe & moisturize nasal passages. Thins & loosens mucous secretions.

Directions

Directions: Shake well before using. The metered pump sprayer provides a precise amount of soothing spray in a fine mist. Clear 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 nostril and depress pump completly while breathing in through 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.

Warnings

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 & 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 - high blood pressure - thyroid disease - diabetes - trouble urinating due to enlarged prostate gland - Not for children under age 6 unless directed by a physician.

active section

Active ingredients: Oxymetazoline HCL 0.05% ................. Nasal Decongestant

directions

Directions: Shake well before using. The metered pump sprayer provides a precise amount of soothing spray in a fine mist. Clear 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 nostril and depress pump completely while breathing in through 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.

inactives

Inactive ingredients: Benzalkonium Chloride, Grapefruit Seed Extract, Purified Water, Xylitol

OTC Purpose

Uses: For temporary relief of nasal decongestion due to colds, hay fever or upper respiratory allergies, or associated with sinusitis. Helps soothe & moisturize nasal passages. Thins & loosens mucous secretions.

image of display carton

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)
CITRUS PARADISI (GRAPEFRUIT) SEED OIL (UNII: 598D944HOL)
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	M012	03/12/2019

Labeler - Xlear Inc. (839884058)

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