SKAPEMED ORIGINAL NASAL by Jiangxi Hemei Pharmaceutical Co., Ltd 84010-034 COMPLETED

SKAPEMED ORIGINAL NASAL by

Drug Labeling and Warnings

SKAPEMED 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]

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

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84010-034 COMPLETED

Active Ingredient

Naphazoline HCL 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

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 this product for more than 3 days.Use only as directed. Frequent or prolongeduse 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.

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 depress pump all the way down with a firm even stroke and sniff deeply. Wipe nozzle clean after use.

When Using

·Do not exceed recommended dosage

·Do not use this product for more than 3 days.Use only as directed. Frequent or prolongeduse 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.

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 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. Retain the box for future reference on fulllabeling.

Inactive ingredients

Borneol,Camphor,glycerin,propylene glycol

PRINCIPAL DISPLAY PANEL

SKAPEMED ORIGINAL NASAL 
naphazoline hcl 1%original nasal spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84010-034
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
BORNEOL (UNII: M89NIB437X)
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84010-034-01	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/09/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	10/09/2024	12/17/2024

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

Establishment
Name	Address	ID/FEI	Business Operations
Jiangxi Hemei Pharmaceutical Co., Ltd		724892056	manufacture(84010-034)

Revised: 12/2024

Document Id: 297202e8-e3cc-8b3a-e063-6294a90ad2dd

34390-5

Set id: 240315eb-8e4e-4e55-e063-6294a90a8b4c

Version: 2

Effective Time: 20241217