DERMFREE ORIGINAL NASAL- naphazoline hcl 0.05%original nasal spray

DERMFREE ORIGINAL NASAL by

Drug Labeling and Warnings

DERMFREE ORIGINAL NASAL by is a Otc medication manufactured, distributed, or labeled by Jiangxi Hemei Pharmaceutical Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Naphazoline HCL 0.05%

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

children under 2 years.

When Using

·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
·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

symptoms persist.

Ask Doctor

children 2 to under 6 years.

Keep Oot Of Reach Of Children

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

Directions

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

do not exceed 25°C

Inactive ingredients

borneol,Camphor,glycerin,Glycerol,menthol,propylene glycol,etc.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DERMFREE ORIGINAL NASAL 
naphazoline hcl 0.05%original nasal spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84010-057
Route of Administration	NASAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
NAPHAZOLINE HCL (UNII: MZ1131787D) (NAPHAZOLINE - UNII:H231GF11BV)	NAPHAZOLINE HCL	0.05 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)
GLYCERIN (UNII: PDC6A3C0OX)
MENTHOL (UNII: L7T10EIP3A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
BORNEOL (UNII: M89NIB437X)
DIGLYCERIN (UNII: 3YC120743U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84010-057-01	30 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	12/19/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	12/19/2024

Labeler - Jiangxi Hemei Pharmaceutical Co., Ltd (724892056)

Establishment
Name	Address	ID/FEI	Business Operations
Jiangxi Hemei Pharmaceutical Co., Ltd		724892056	manufacture(84010-057)