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 0.05%

Purpose

Nasal Decongestant 

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.

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.

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.

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

Principal Display panel 1 FLOZ 

Leader          NDC: 70000-0665-1

12 Hour ND Nasal Decongstant

Oxymetazoline HCL 0.05% 

Nasal Decongestant 

1 FLOZ (30ml)

INGREDIENTS AND APPEARANCE

LEADER NASAL DECONGESTANT 
oxymetazoline hydrochloride spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70000-0665
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
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)
POVIDONE (UNII: FZ989GH94E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70000-0665-1	1 in 1 CARTON	03/31/2024
1		30 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	03/31/2024

Labeler - Cardinal Health 110,Inc (063997360)