LEADER ORIGINAL 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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Drug Facts

Active Ingredient                                                                   Purpose

Oxymetazoline hydrochloride 0.05% ......................................Nasal decongestant

Uses

Warnings

For external use only

Ask a doctor before use if you have

When using this product

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.

Directions

Other information

Inactive ingredients: benzalkonium chloride solution, edetate disodium, polyethylene glycol, sodium phosphate dibasic, sodium phosphate monobasic, water

DISTRIBUTED BY CARDINAL HEALTH

DUBLIN, OHIO 43017

CIN 4584645

www.myleader.com

1-800-200-6313

Made in Korea

image of carton label

LEADER ORIGINAL NASAL 
oxymetazoline hydrocholoride spray
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:37205-735
Route of Administration NASAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OXYMETAZOLINE HYDROCHLORIDE (UNII: K89MJ0S5VY) (OXYMETAZOLINE - UNII:8VLN5B44ZY) OXYMETAZOLINE HYDROCHLORIDE 0.05 g  in 100 mL
Inactive Ingredients
Ingredient Name Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
SODIUM PHOSPHATE (UNII: SE337SVY37)  
WATER (UNII: 059QF0KO0R)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:37205-735-10 1 in 1 CARTON
1 30 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 09/30/2012
Labeler - CARDINAL HEALTH (097537435)

Revised: 9/2012
Document Id: 8e61b7f5-7998-41db-b8dd-51c1608d84dc
Set id: 7dd28a88-85f9-4e01-a4f6-7e4420eecd1e
Version: 1
Effective Time: 20120930
 
CARDINAL HEALTH