Xlear Nasal Decongestant Liquid
FDA Label NDC 27017-018

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Xlear Inc. for the product Xlear Nasal Decongestant (NDC 27017-018). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding warnings and precautions, otc - purpose, indications & usage, otc - keep out of reach of children, warnings, otc - active ingredient, dosage & administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Warnings And Precautions

Display Box (Xdc Box R4j)

Display Box (Xdc Box R4j)

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

Bottle Label (Xdc Label R4j)

Bottle Label (Xdc Label R4j)

Bottle Label (Xdc Label R4j)

Bottle Label (Xdc Label R4j)

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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