Active Ingredient
Naphazoline HCL 0.05%.
Dermfree Original Nasal Spray
FDA Label NDC 85248-111
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Jiangxi Yudexi Pharmaceutical Co., Ltd for the product Dermfree Original Nasal (NDC 85248-111). 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 active ingredient, purpose, use, warnings, do not use, when using, stop use, ask doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Nasal Decongestant
Use
temporarily relieves .nasal congestion due to a cold, hay fever, or other upper respiratory allergies .sinus congestion and pressure
Warnings
Ask a doctor before use if you have
·heart disease·high blood pressure·thyroid disease·diabetes·trouble urinating due to enlarged prostate gland
Do Not Use
.Do not use this product for more than 3 days.Use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen. .Temporary discomfort such as burning,stinging,sneezing,or increased nasal discharge may occur.
·Use of this container by more than one person may spread infection. children under 6 years.
When Using
When using this product
.Do not exceed recommended dosage
.Do not use this product for more than 3 days.Use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen. .Temporary discomfort such as burning,stinging,sneezing,or increased nasal discharge may occur.
·Use of this container by more than one person may spread infection.
Stop Use
Stop use and ask a doctor if .symptoms persist
.If pregnant or breast-feeding, ask a health professionalbefore use.
Ask Doctor
. children 6 to under 12 years.
.if symptoms persist
.If pregnant or breast-feeding, ask a health professionalbefore use.
Keep Oot Of Reach Of Children
if swallowed, get medical help or contact a Poison Control Center right away.
Directions
Adults&children 12 years & older(with adult supervision ): 2 or 3 sprays in each nostril,not more often than every 10 to 12 hours. Do not exceed 2 times in 24 hours.
Ask a doctor: children 6 to under 12 years,Do not use children under 6 years.
Other Information
do not exceed 25°C
Inactive Ingredients
borneol,Camphor,glycerin,Glycerol,menthol,propylene glycol
* Please review the disclaimer below.
