FDA Label for Xlear Nasal Decongestant

View Indications, Usage & Precautions

Xlear Nasal Decongestant Product Label

The following document was submitted to the FDA by the labeler of this product Xlear Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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.


Otc - 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.


Otc - 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.


Otc - 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


Package Label.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.


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