LEADER ADVANCED FORMULA EYE DROPS - dextran 70 solution 
HANLIM PHARM. CO., LTD.

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 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

image of carton labelEnter section text here

LEADER ADVANCED FORMULA EYE DROPS 
dextran 70 solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11716-1104
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTRAN 70 (UNII: 7SA290YK68) (DEXTRAN 70 - UNII:7SA290YK68) DEXTRAN 700.001 mL  in 1 mL
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) (POLYETHYLENE GLYCOL 400 - UNII:B697894SGQ) POLYETHYLENE GLYCOL 4000.01 mL  in 1 mL
POVIDONE (UNII: FZ989GH94E) (POVIDONE - UNII:FZ989GH94E) POVIDONE0.01 mL  in 1 mL
TETRAHYDROZOLINE HYDROCHLORIDE (UNII: 0YZT43HS7D) (TETRAHYDROZOLINE - UNII:S9U025Y077) TETRAHYDROZOLINE HYDROCHLORIDE0.0005 mL  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:11716-1104-11 in 1 CARTON
115 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34905/06/2010
Labeler - HANLIM PHARM. CO., LTD. (687986034)

Revised: 5/2010
Document Id: ddd93887-104b-4d41-8cdb-bf19ef9154a1
Set id: 01d4b9b9-7a16-428c-9194-d9437e17b133
Version: 2
Effective Time: 20100506
 
HANLIM PHARM. CO., LTD.