LEADER ADVANCED FORMULA- dextran70, polyethylene glycol, povidone, tetrahydrozoline hcl solution 
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 ingredients                                                               Purpose

Dextran 70 0.1%................................................................Lubricant

Polyethylene glycol 400 1%.................................................Lubricant

Povidone 1%......................................................................Lubricant

Tetrahydrozoline HCL 0.05%...............................................Redness reliever

Uses

Warnings

Ask a doctor before use if you have narrow angle glaucoma

When using this product

Stop use and ask a doctor if

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of the reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Other information

some users may experience a brief tingling sensation

store at 15o to 25oC (59o to 77oF)

Inactive ingredients:

benzalkonium chloride, boric acid, edetate disodium, purified water, sodium chloride, and sodium borate

DISTRIBUTED BY CARDINAL HEALTH

DUBLIN, OHIO 43017

CIN 3256021

www.myleader.com

1-800-200-6313

image description

LEADER ADVANCED FORMULA 
dextran70, polyethylene glycol, povidone, tetrahydrozoline hcl solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37205-224
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTRAN 70 (UNII: 7SA290YK68) (DEXTRAN 70 - UNII:7SA290YK68) DEXTRAN 701 mg  in 1 mL
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) (POLYETHYLENE GLYCOL 400 - UNII:B697894SGQ) POLYETHYLENE GLYCOL 40010 mg  in 1 mL
POVIDONES (UNII: FZ989GH94E) (POVIDONE - UNII:FZ989GH94E) POVIDONES10 mg  in 1 mL
TETRAHYDROZOLINE HYDROCHLORIDE (UNII: 0YZT43HS7D) (TETRAHYDROZOLINE - UNII:S9U025Y077) TETRAHYDROZOLINE HYDROCHLORIDE0.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
BORIC ACID (UNII: R57ZHV85D4)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
WATER (UNII: 059QF0KO0R)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SODIUM BORATE (UNII: 91MBZ8H3QO)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:37205-224-051 in 1 CARTON11/29/2016
115 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34901/04/2012
Labeler - CARDINAL HEALTH (097537435)

Revised: 11/2016
Document Id: 6b1fa448-895c-424f-8e31-af89caf79d88
Set id: d657cd50-39b0-4ed9-b997-bda99128b947
Version: 2
Effective Time: 20161129
 
CARDINAL HEALTH