LEADER NASAL DECONGESTANT- oxymetazoline hydrochloride spray

Leader Nasal Decongestant by

Drug Labeling and Warnings

Leader Nasal Decongestant by is a Otc medication manufactured, distributed, or labeled by Cardinal Health 110,Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient 

Oxymetazoline HCL 0.05%

Purpose

Nasal Decongestant 

Uses 

Temporarily relieves nasal congestion due to:

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

Warnings 

Ask a Doctor before use if you have

• heart diease
• high blood pressure
• diabetes
• thyroid disease
• trouble urinating due to enlarged prostate gland

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 

PREGNANCY OR BREAST FEEDING

ask a health professional before use.

Keep out of the reach of children

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

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.

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

PRINCIPAL DISPLAY PANEL

Leader  Original Nasal Spray NDC: 70000-0676-1
Oxymetazoline Hydrochloride 0.05%
12 hour Nasal Mist Nasal Decongestant
1/2 FLOZ (15ML)

INGREDIENTS AND APPEARANCE

LEADER NASAL DECONGESTANT 
oxymetazoline hydrochloride spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70000-0676
Route of Administration	NASAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OXYMETAZOLINE HYDROCHLORIDE (UNII: K89MJ0S5VY) (OXYMETAZOLINE - UNII:8VLN5B44ZY)	OXYMETAZOLINE HYDROCHLORIDE	0.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
POVIDONE (UNII: FZ989GH94E)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70000-0676-1	1 in 1 CARTON	05/30/2024
1		15 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	05/30/2024

Labeler - Cardinal Health 110,Inc (063997360)