XLEAR NASAL DECONGESTANT- nasal spray liquid 
Xlear Inc.

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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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.

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.

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

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

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 Ingredients: Benzalkonium Chloride, purified water, xylitol

bottle label

bottle label

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.

XLEAR NASAL DECONGESTANT 
nasal spray liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:27017-018
Route of AdministrationNASAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OXYMETAZOLINE HYDROCHLORIDE (UNII: K89MJ0S5VY) (OXYMETAZOLINE - UNII:8VLN5B44ZY) OXYMETAZOLINE HYDROCHLORIDE0.0005 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
XYLITOL (UNII: VCQ006KQ1E)  
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:27017-018-011 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product03/12/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34103/12/2019
Labeler - Xlear Inc. (839884058)
Registrant - Xlear Inc. (839884058)
Establishment
NameAddressID/FEIBusiness Operations
Xlear Inc.839884058manufacture(27017-018)

Revised: 12/2020
 
Xlear Inc.