Otc - Active Ingredient
Active Ingredient
Naphazoline HCL0.05%
Dermfree Original Nasal
FDA Label NDC 85248-006
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 85248-006). 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, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, otc - ask doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Nasal Decongestant
Indications & Usage
Use
temporarily relieves ·Nasal congestion due to a cold, hay fever, or other upper respiratory allergies ·Sinus congestion and pressure
Warnings
Warnings
1.Do not use if you are allergic to the ingredients. 2.Ask a doctor before use if you have
Heart disease、High blood pressure、Thyroid disease、Diabetes、Trouble urinating due to enlarged prostate gland 3.When using this product
·Do not exceed recommended dosage
·After continuous use for 3 days, please stop using for 1 day, please use as instructed.Do not use without nasal congestion.Frequent or prolonged use may cause nasalcongestion 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.
Otc - Do Not Use
Do not use
children under 6 years
Otc - When Using
When Using
After continuous use for 3 days, please stop using for 1 day, please use as instructed.Do not use without nasal congestion.Frequent or prolonged use may cause nasalcongestion 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.
Otc - Stop Use
Stop Use
Stop use and ask a doctor if symptoms persist
Otc - Ask Doctor
Ask Doctor
children 6 to under 12 years.
Otc - Keep Out Of Reach Of Children
Keep Oot Of Reach Of Children
if swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
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 doses in 24 hours.
Ask a doctor: children 6 to under 12 years.
Do not use children under 6 years
Shake well before use. Before using the first time, remove the protective cap &safely clip from the tip and prime metered pump by depressing firmly severaltimes. To spray, hold bottle with thumb at base and nozzle between first and second fingers. Without tilting head, insert nozzle into nostril. Fully depresspump all the way down with a firm even stroke and sniff deeply. Wipe nozzleclean after use.
Other Safety Information
Other information
do not exceed 25°C.Retain the box for future reference on full labeling
Inactive Ingredient
Inactive ingredients
Borneol,Camphor,glycerin,propylene glycol
Package Label.Principal Display Panel
Drug facts
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