LEADER NASAL- oxymetazoline hydrochloride spray 
Cardinal Health

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Cardinal Health Nasal Spray Drug Facts

Active ingredient

Oxymetazoline hydrochloride 0.05%

Purpose

Nasal decongestant

Uses

temporarily relieves nasal congestion due to:
common cold
hay fever
upper respiratory allergies
temporarily relieves sinus congestion and pressure
shrinks swollen nasal membranes so you can breathe more freely

Warnings

Ask a doctor before use if you have

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

When using this product

do not use more than directed
do not use for more than 3 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

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions

adults and children 6 to under 12 years of age (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 any 24-hour period.
children under 6 years of age: ask a doctor

To spray, squeeze bottle quickly and firmly. Do not tilt head backward while spraying. Wipe nozzle clean after use. Replace cap tightly to maintain child resistance.

Other information

store at 20-25°C (68-77°F)
retain carton for future reference on full labeling

Inactive ingredients

benzalkonium chloride solution, benzyl alcohol, dibasic sodium phosphate, edetate disodium, monobasic sodium phosphate, polyethylene glycol, povidone, propylene glycol, purified water

Questions or comments?

1-800-719-9260

Principal Display Panel

SEE NEW DIRECTIONS

Compare to Afrin ® Original active ingredient

Bonus Size

Original

Nasal Spray

Oxymetazoline HCl 0.05%

Nasal Decongestant

12 Hour Relief

Fast, Powerful Congestion Relief

For Colds & Allergies

Maximum Strength

1 OZ + 0.25 OZ FREE

1.25 FL OZ (37 mL)

Leader Nasal Spray image 1
Leader Nasal Spray image 2
LEADER NASAL 
oxymetazoline hydrochloride spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49781-137
Route of AdministrationNASAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OXYMETAZOLINE HYDROCHLORIDE (UNII: K89MJ0S5VY) (OXYMETAZOLINE - UNII:8VLN5B44ZY) OXYMETAZOLINE HYDROCHLORIDE0.05 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
POVIDONES (UNII: FZ989GH94E)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)  
Product Characteristics
ColorWHITE (Translucent) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49781-137-701 in 1 CARTON12/11/201412/11/2014
137 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34112/11/201412/11/2014
Labeler - Cardinal Health (097537435)

Revised: 11/2017
 
Cardinal Health