SPL v1
SPL
SPL Set ID 3432c4a6-3e48-db91-e063-6394a90a28ee
Route
NASAL
Published
Effective Date 2025-05-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Naphazoline (0.05 g)
Inactive Ingredients
Borneol Glycerin Camphor (synthetic) Propylene Glycol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-05-03

Description

Active Ingredient Naphazoline HCL0.05%


Medication Information

Warnings and Precautions

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

·After continuous use for 3 days, please stop using for 1 day, please use as instructed.Do not use without nasal congestion.Frequent or prolonged use may cause nasalcongestion to recur or worsen.

·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.

Indications and Usage

Use

temporarily relieves ·Nasal congestion due to a cold, hay fever, or other upper respiratory allergies ·Sinus congestion and pressure

Dosage and Administration

Directions

Adults&children 12 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 6 to under 12 years.

Do not use children under 6 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 severaltimes. 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 nozzleclean after use.

Description

Active Ingredient Naphazoline HCL0.05%

Section 50565-1

Keep Oot Of Reach Of Children

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

Section 50566-9

Stop Use

Stop use and ask a doctor if symptoms persist

Section 50567-7

When Using

After continuous use for 3 days, please stop using for 1 day, please use as instructed.Do not use without nasal congestion.Frequent or prolonged use may cause nasalcongestion to recur or worsen..

·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.

Section 50569-3

Ask Doctor

children 6 to under 12 years.

Section 50570-1

Do not use

children under 6 years

Section 51727-6

Inactive ingredients

Borneol,Camphor,glycerin,propylene glycol

Section 51945-4

Drug facts

Section 55105-1

Purpose

Nasal Decongestant

Section 55106-9

Active Ingredient

Naphazoline HCL0.05%

Section 60561-8

Other information

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


Structured Label Content

Indications and Usage (34067-9)

Use

temporarily relieves ·Nasal congestion due to a cold, hay fever, or other upper respiratory allergies ·Sinus congestion and pressure

Dosage and Administration (34068-7)

Directions

Adults&children 12 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 6 to under 12 years.

Do not use children under 6 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 severaltimes. 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 nozzleclean after use.

Warnings and Precautions (34071-1)

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

·After continuous use for 3 days, please stop using for 1 day, please use as instructed.Do not use without nasal congestion.Frequent or prolonged use may cause nasalcongestion to recur or worsen.

·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.

Section 50565-1 (50565-1)

Keep Oot Of Reach Of Children

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

Section 50566-9 (50566-9)

Stop Use

Stop use and ask a doctor if symptoms persist

Section 50567-7 (50567-7)

When Using

After continuous use for 3 days, please stop using for 1 day, please use as instructed.Do not use without nasal congestion.Frequent or prolonged use may cause nasalcongestion to recur or worsen..

·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.

Section 50569-3 (50569-3)

Ask Doctor

children 6 to under 12 years.

Section 50570-1 (50570-1)

Do not use

children under 6 years

Section 51727-6 (51727-6)

Inactive ingredients

Borneol,Camphor,glycerin,propylene glycol

Section 51945-4 (51945-4)

Drug facts

Section 55105-1 (55105-1)

Purpose

Nasal Decongestant

Section 55106-9 (55106-9)

Active Ingredient

Naphazoline HCL0.05%

Section 60561-8 (60561-8)

Other information

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


Advanced Ingredient Data


Raw Label Data

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