Leader Nasal Decongestant Spray

Leader Nasal Decongestant Spray
SPL v4
SPL
SPL Set ID 98bf8e84-b555-4b5a-90a0-7837a5560289
Route
NASAL
Published
Effective Date 2024-04-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Oxymetazoline (0.5 mg)
Inactive Ingredients
Benzalkonium Chloride Microcrystalline Cellulose Glycerin Polyethylene Glycol 300 Edetate Disodium Sodium Phosphate, Monobasic Povidone Propylene Glycol Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-03-31

Description

Oxymetazoline 0.05%

Purpose

Nasal Decongestant 


Medication Information

Purpose

Nasal Decongestant 

Description

Oxymetazoline 0.05%

Uses

Temporarily relieves nasal congestion due to:

  • common cold
  • hay fever
  • upper respiroty allergies
  • temporarily relieves sinus congestion and pressure
  • Shrinks swollen membranes so you can breathe more freely
Warnings

Ask a Doctor before use if you have

  • heart diease
  • high blood pressure
  • diabetes
  • thyiod diease
  • trouble urinating due to enlarged rostate gland.

Directions
  • Before using for the first time, remove the protective cap form the tip and prime the pump by depressing pump firmly several times. To spray, hold bottle with thumb at base and nozzle between first and second fingers. Without tilting head, insert nozzle into nostrile. Fully depress rim with a firm and even stroke, and sniff deeply.
  • Wipe nozzle clean after use.
  • Adults and children 6 to under 12 years of age (with adult supervision):2 or 3 sprays in each nostril not more than every 10 to 12 hours. Do not exceed 2 doses in any 24-hour period.
  • Children under 6 years of age consult a doctor.
Drug Facts 

Active Ingredient

Oxymetazoline 0.05%

Other Information 
  • store between 20° - 25°C (68° to 77°F)
  • retain carton for future reference on full labeling
Inactive Ingredient 

Benzalkonium Chloride, Disodium EDTA, Glycerin, Microcrystalline Cellulose and Carboxymethylcellulose Sodium, Polyethylene Glycol 300, Povidone, Propylene Glycol, Purified Water, Sodium Phosphate Dibasic, Sodium Phosphate Monobasic

When Using This Product 

Do not use more than directed

  • do not use for more than three 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 an increase in nasal discharge may occur.
  • use of this container by more than one person may spread infection.

Stop use and ask a Doctor if symptoms persist

Principal Display Panel 1 Floz 

Leader          NDC 70000-0665-1

12 Hour ND Nasal Decongstant

Oxymetazoline HCL 0.05% 

Nasal Decongestant 

1 FLOZ (30ml)

Keep Out of the Reach of Children

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


Structured Label Content

Uses

Temporarily relieves nasal congestion due to:

  • common cold
  • hay fever
  • upper respiroty allergies
  • temporarily relieves sinus congestion and pressure
  • Shrinks swollen membranes so you can breathe more freely
Purpose

Nasal Decongestant 

Warnings

Ask a Doctor before use if you have

  • heart diease
  • high blood pressure
  • diabetes
  • thyiod diease
  • trouble urinating due to enlarged rostate gland.

Directions
  • Before using for the first time, remove the protective cap form the tip and prime the pump by depressing pump firmly several times. To spray, hold bottle with thumb at base and nozzle between first and second fingers. Without tilting head, insert nozzle into nostrile. Fully depress rim with a firm and even stroke, and sniff deeply.
  • Wipe nozzle clean after use.
  • Adults and children 6 to under 12 years of age (with adult supervision):2 or 3 sprays in each nostril not more than every 10 to 12 hours. Do not exceed 2 doses in any 24-hour period.
  • Children under 6 years of age consult a doctor.
Drug Facts 

Active Ingredient

Oxymetazoline 0.05%

Other Information  (Other information )
  • store between 20° - 25°C (68° to 77°F)
  • retain carton for future reference on full labeling
Inactive Ingredient  (Inactive ingredient )

Benzalkonium Chloride, Disodium EDTA, Glycerin, Microcrystalline Cellulose and Carboxymethylcellulose Sodium, Polyethylene Glycol 300, Povidone, Propylene Glycol, Purified Water, Sodium Phosphate Dibasic, Sodium Phosphate Monobasic

When Using This Product  (When using this product )

Do not use more than directed

  • do not use for more than three 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 an increase in nasal discharge may occur.
  • use of this container by more than one person may spread infection.

Stop use and ask a Doctor if symptoms persist

Principal Display Panel 1 Floz  (Principal Display panel 1 FLOZ )

Leader          NDC 70000-0665-1

12 Hour ND Nasal Decongstant

Oxymetazoline HCL 0.05% 

Nasal Decongestant 

1 FLOZ (30ml)

Keep Out of the Reach of Children (Keep out of the reach of children)

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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)