DERMFREE ORIGINAL NASAL by Jiangxi Hemei Pharmaceutical Co., Ltd 84010-028 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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84010-028 COMPLETED

Active Ingredient

NaphazolineHCL1%.

Purpose

Nasal Decongestant

Use

temporarily relieves

Nasal congestion due to a cold, hay fever, or other upper respiratory allergies

Sinus congestion and pressure

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

Do not use

.Do not use this product for more than 3 days.Use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen.

.Temporary discomfort such as burning,stinging,sneezing,or increased nasaldischarge may occur.
·Use of this container by more than one person may spread infection.

children under 2 years.

When Using

Do not exceed recommended dosage

Stop Use

Stop use and ask a doctor if 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 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 2 to under 6 years,
Do not use children under 2 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 depresspump all the way down with a firm even stroke and sniff deeply. Wipe nozzle clean after use.

Other information

do not exceed 25°C.Retain the box for future reference on full labeling

Inactive ingredients

Borneol,Camphor,glycerin,propylene glycol

PRINCIPAL DISPLAY PANEL

DERMFREE ORIGINAL NASAL 
naphazoline hcl 1%original nasal spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84010-028
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
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)
GLYCERIN (UNII: PDC6A3C0OX)
BORNEOL (UNII: M89NIB437X)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84010-028-01	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/05/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	09/05/2024	12/17/2024

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

Establishment
Name	Address	ID/FEI	Business Operations
Jiangxi Hemei Pharmaceutical Co., Ltd		724892056	manufacture(84010-028)

Revised: 12/2024

Document Id: 2971eeb7-3426-5d82-e063-6294a90a1229

34390-5

Set id: 2159fa94-7d26-7ea8-e063-6294a90a80bf

Version: 2

Effective Time: 20241217