85248-112update

Manufacturer
Jiangxi Yudexi Pharmaceutical Co., LTD
Effective date
2026-07-21
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
daily-update
Hydrated at
2026-07-25 05:10:17

Label at a glance#

ProductDERMFREE ORIGINAL NASAL
Active ingredientNAPHAZOLINE HCL
Label structure13 sections

Dosage and administration

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 several times. To spray,hold...

Storage and handling

do not exceed 25°C.Retain the box for future reference on full labeling. Country of Origin: Made In China

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Naphazoline HCL 0.05%.

Purpose

OTC - PURPOSE SECTION

Nasal Decongestant

Use

INDICATIONS & USAGE SECTION

temporarily relieves .Nasal congestion due to a cold, hay fever, or other upper respiratory allergies .Sinus congestion and pressure

Warnings

WARNINGS SECTION

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

Do not use

OTC - DO NOT USE SECTION

Do not use if you are allergic to the ingredients.
Do not use without nasal congestion. Do not use:children under 6 years.

When Using

OTC - WHEN USING SECTION

·Do not exceed recommended dosage.
·After continuous use for 3 days, please stopusing for 1 day, please use as instructed.Do not use without nasal congestion.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

OTC - STOP USE SECTION

Stop use and ask a doctor if symptoms persist.
If pregnant or breast-feeding ,ask a healthprofessional before use.

Ask Doctor

OTC - ASK DOCTOR SECTION

Stop use and ask a doctor if symptoms persist.
If pregnant or breast-feeding ,ask a health professional before use.
Ask a doctor before use if you have
Heart disease, High blood pressure, Thyroiddisease, Diabetes, Trouble urinating due toenlarged prostate gland.
Ask a doctor :children 6 to under 12 years.

Keep Oot Of Reach Of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

if swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

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 several times. To spray,hold bottle with thumb at base and nozzle between first and second fingers. Without tilting head, insert nozzle into nostril. Fully depress pump all the way down with a firmeven stroke and sniff deeply. Wipe nozzle clean after use

Other information

STORAGE AND HANDLING SECTION

do not exceed 25°C.Retain the box for future reference on full labeling.
Country of Origin: Made In China

Inactive ingredients

INACTIVE INGREDIENT SECTION

Borneol,Camphor,glycerin,propylene glycol

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

0.050.05

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e18001c8-33ae-5f66-9cdc-a39724bd4573Product name120140508

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85248-11285248-112-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12026-02-08full-release2026-06-01 01:37:32

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DERMFREE ORIGINAL NASALNAPHAZOLINE HCL 0.05%ORIGINAL NASALJiangxi Yudexi Pharmaceutical Co., LTD4a4d3a2b-a4ed-c736-e063-6394a90a96df2026-07-21WarningsExact identifier
ndc (package): 85248-112-01
ndc (product): 85248-112
ndc11 (package): 85248011201
spl id: 572bb880-5d41-7d4b-e063-6394a90ac312
spl set id: 4a4d3a2b-a4ed-c736-e063-6394a90a96df

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.