DERMFREE ORIGINAL NASAL by Jiangxi Hemei Pharmaceutical Co., Ltd 84010-011 COMPLETED

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]

DERMFREE ORIGINAL NASAL- naphazoline hcl 1%original nasal spray 
Jiangxi Hemei Pharmaceutical Co., Ltd

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84010-011 COMPLETED

Active Ingredient

NaphazolineHCL 1%

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

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

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

Stop Use

symptoms persist.

Ask Doctor

children 2 to under 6 years.

Keep Oot Of Reach Of Children

ifswallowed, 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,Glycerolmenthol,propylene glycol,etc.

PRINCIPAL DISPLAY PANEL

DERMFREE ORIGINAL NASAL 
naphazoline hcl 1%original nasal spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84010-011
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
NAPHAZOLINE HYDROCHLORIDE (UNII: MZ1131787D) (NAPHAZOLINE - UNII:H231GF11BV)	NAPHAZOLINE HYDROCHLORIDE	1 g  in 100 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84010-011-01	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/29/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	04/29/2024	12/17/2024

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

Establishment
Name	Address	ID/FEI	Business Operations
Jiangxi Hemei Pharmaceutical Co., Ltd		724892056	manufacture(84010-011)

Revised: 12/2024

Document Id: 2971ff46-918f-5078-e063-6394a90a5304

34390-5

Set id: 17397fc0-1f42-a32b-e063-6294a90afce5

Version: 2

Effective Time: 20241217