LEADER SEVERE CONGESTION 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 3467651

www.myleader.com

1-800-200-6313

Made in Korea

image of carton labelEnter section text here

LEADER SEVERE CONGESTION NASAL 
oxymetazoline hydrochloride spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37205-336
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)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:37205-336-101 in 1 CARTON
130 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34102/14/2012
Labeler - CARDINAL HEALTH (097537435)

Revised: 2/2012
Document Id: 87ca88a1-819d-4af7-b852-3433f525e100
Set id: 5ae3853d-926c-45c2-893a-331f6c418945
Version: 1
Effective Time: 20120214
 
CARDINAL HEALTH