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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Active Ingredient                                                           Purpose

Oxymetazoline HCL 0.05%.............................................Nasal Decongestant

Uses

Warnings

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 hep or contact a Poison Control Center right away.

Directions

Other information

Inactive ingredients

benzalkonium chloride, benzyl alcohol, dibasic sodium phosphate hydrate, disodium EDTA, distilled water, monobasic sodium phosphate dihydrate, PEG 1450, PVP K30

Distributed By:

Cardinal Health

Dublin, Ohio 43017

Made in Korea

image description

LEADER ORIGINAL NASAL 
oxymetazoline hydrochloride spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49781-041
Route of AdministrationNASAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OXYMETAZOLINE HYDROCHLORIDE (UNII: K89MJ0S5VY) (OXYMETAZOLINE - UNII:8VLN5B44ZY) OXYMETAZOLINE HYDROCHLORIDE0.05 mg  in 100 mg
Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
SODIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: 94255I6E2T)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
WATER (UNII: 059QF0KO0R)  
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE (UNII: 5QWK665956)  
POLYETHYLENE GLYCOL 1450 (UNII: OJ4Z5Z32L4)  
POVIDONE K30 (UNII: U725QWY32X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49781-041-011 in 1 CARTON11/07/2016
130 mg in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34108/29/2013
Labeler - Cardinal Health (097537435)

Revised: 11/2016
Document Id: 341dc604-9a56-448d-8e47-2ceb1d2f83ee
Set id: d27ea330-7624-4297-8697-0e9c7bf3fdf0
Version: 2
Effective Time: 20161107
 
Cardinal Health