FDA.reportPublic FDA data

DERMFREE ORIGINAL NASAL

Manufacturer
Jiangxi Hemei Pharmaceutical Co., Ltd
Effective date
2024-04-29
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 21:04:01

Label at a glance#

ProductDERMFREE ORIGINAL NASAL
Active ingredientNAPHAZOLINE HYDROCHLORIDE
Label structure13 sections

Dosage and administration

adults & children 6 yrs.& older (with adult supervision)2 or 3 sprays in eachnostril, not more often than every 10 to 12 hours. Do not exceed 2 doses in 24 hours

Storage and handling

do not exceed 25°C

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

NaphazolineHCL 1%

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

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

OTC - DO NOT USE SECTION

use of this container by more than one person may spread infection

When Using

OTC - WHEN USING SECTION

*do not exceed recommended dosage
*do not use this product for more than 3 days. Use only as directed. Frequentor prolonged use may cause nasal congestion to recur or worsentemporary discomfort such as burning, stinging,sneezing, or increased nasaldischarge may occur

Stop Use

OTC - STOP USE SECTION

symptoms persist.

Ask Doctor

OTC - ASK DOCTOR SECTION

children 2 to under 6 years.

Keep Oot Of Reach Of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

ifswallowed, get medical help or contact a Poison Control Center right away

Directions

DOSAGE & ADMINISTRATION SECTION

adults & children 6 yrs.& older (with adult supervision)2 or 3 sprays in eachnostril, not more often than every 10 to 12 hours. Do not exceed 2 doses in 24 hours

Other information

STORAGE AND HANDLING SECTION

do not exceed 25°C

Inactive ingredients

INACTIVE INGREDIENT SECTION

borneol,Camphor,glycerin,Glycerolmenthol,propylene glycol,etc.

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84010-01184010-011-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
CAMPHOR (SYNTHETIC)5TJD82A1ETIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
DIGLYCERIN3YC120743UIACT
MENTHOLL7T10EIP3AIACT
BORNEOLM89NIB437XIACT
NAPHAZOLINE HYDROCHLORIDEMZ1131787DACTIB

Source Document#

Source XML

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
2971ff46-918f-5078-e063-6394a90a530417397fc0-1f42-a32b-e063-6294a90afce52024-12-17WarningsExact identifier
spl set id: 17397fc0-1f42-a32b-e063-6294a90afce5

Reported adverse events (FAERS/openFDA)#

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