Otc - Active Ingredient
Oxymetazoline hydrochloride 0.05% Purpose Nasal decongestant
Fgper Nasal Decongestant Spray
FDA Label NDC 85593-161
7 label sections · Submitted to the FDA by Guangzhou Chuanma International Trading Co.,ltd. · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Guangzhou Chuanma International Trading Co.,ltd. for the product Fgper Nasal Decongestant (NDC 85593-161). 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 otc - active ingredient, otc - purpose, otc - keep out of reach of children, warnings, indications & usage, dosage & administration, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Temporarily relieves nasal congestion due to:common cold, hay fever, upper respiratoryallergiesTemporarily relieves sinus congestion andpressureshrinks swollen nasal membranes so you canbreathe more freely
Otc - Keep Out Of Reach Of Children
Keep out of reach of children If swallowed, get medical help or contact aPoison Control Center right away.
Warnings
Warnings: For external use only. For nasaluseonly.
Indications & Usage
When using this product
Do not exceed recommended dosageDo not use for more than 3 days. Use only asdirected. Frequent or prolonged use may causenasal congestion to recur or worsen.Temporary discomfort such as burning, stinging,sneezing or an increase in nasal discharge may occurmay spread infection
Dosage & Administration
adults and children 6 to under 12 years of age(with adult supervision):2 or3 sprays in eachnostril not more often than every 10 to 12 hours.Do not exceed 2 doses in any 24-hour period.children under 6 years of age: ask a doctor.
Inactive Ingredient
Inactive ingredients
purified water, sodium chloride
benzalkonium chloride,glycerin, methylparaben,
* Please review the disclaimer below.
