Leader Nasal Decongestant Spray Oxymetazoline

Leader Nasal Decongestant Spray Oxymetazoline
SPL v2
SPL
SPL Set ID 6594c117-6ffc-4bda-8bbf-e91c810f2c3f
Route
NASAL
Published
Effective Date 2024-05-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-05-30
Description

Oxymetazoline HCL 0.05%

Purpose

Nasal Decongestant 

Medication Information

Purpose

Nasal Decongestant 

Description

Oxymetazoline HCL 0.05%

Uses 

Temporarily relieves nasal congestion due to:

  • common cold
  • hay fever
  • sinusitis
  • upper respiratory allergies
  • shrinks swollen membranes so you can breathe more freely
Section 51945-4

Leader  Original Nasal Spray NDC 70000-0676-1

Oxymetazoline Hydrochloride 0.05%

12 hour Nasal Mist Nasal Decongestant

1/2 FLOZ (15ML)

Section 53414-9

ask a health professional before use.

Drug Facts

Warnings 

Directions 
  • 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.To spray, squeeze bottle quickly and firmly. Do not tilt head backwards while spraying, wipe nozzle clean after use.
Active Ingredient 

Oxymetazoline HCL 0.05%

Other Information 

store between 20° and 25°C (68° to 77°F)

retain carton for future reference on full labeling

Inactive Ingredients 

benzalkonium chloride, edetate disodium, glycerin, polyethylene glycol, povidone, propylene glycol, sodium phosphate dibasic, sodium phosphate monobasic, water

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 

Keep Out of the Reach of Children

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

Ask A Doctor Before Use If You Have
  • heart diease
  • high blood pressure
  • diabetes
  • thyroid disease
  • trouble urinating due to enlarged prostate gland

Structured Label Content

Uses 

Temporarily relieves nasal congestion due to:

  • common cold
  • hay fever
  • sinusitis
  • upper respiratory allergies
  • shrinks swollen membranes so you can breathe more freely
Section 51945-4 (51945-4)

Leader  Original Nasal Spray NDC 70000-0676-1

Oxymetazoline Hydrochloride 0.05%

12 hour Nasal Mist Nasal Decongestant

1/2 FLOZ (15ML)

Section 53414-9 (53414-9)

ask a health professional before use.

Purpose

Nasal Decongestant 

Drug Facts

Warnings 

Directions 
  • 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.To spray, squeeze bottle quickly and firmly. Do not tilt head backwards while spraying, wipe nozzle clean after use.
Active Ingredient  (Active ingredient )

Oxymetazoline HCL 0.05%

Other Information  (Other information )

store between 20° and 25°C (68° to 77°F)

retain carton for future reference on full labeling

Inactive Ingredients 

benzalkonium chloride, edetate disodium, glycerin, polyethylene glycol, povidone, propylene glycol, sodium phosphate dibasic, sodium phosphate monobasic, water

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 (Stop use and ask a doctor if)

Symptoms persist 

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.

Ask A Doctor Before Use If You Have (Ask a Doctor before use if you have)
  • heart diease
  • high blood pressure
  • diabetes
  • thyroid disease
  • trouble urinating due to enlarged prostate gland

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:07.832934 · Updated: 2026-03-14T23:03:01.087200