LEADER DRY EYE RELIEF - 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)

Hypromellose 2910 (0.3%).............................................................(Lubricant)

Uses

Warnings

For external use only. Do not use: If this solution changes color or becomes cloudy or if you are sensitive to any ingredient in this product.

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

Inactive Ingredients: Benzalkonium Chloride, Potassium Chloride, Disodium Chloride, Sodium Borate, Sodium Chloride, Boric Acid, Sterile Water, Purified Water, Sodium Chloride, and Sodium Citrate

image of carton labelEnter section text here

LEADER DRY EYE RELIEF 
dextran 70 solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11716-9637
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
HYPROMELLOSE 2910 (4000 CPS) (UNII: RN3152OP35) (HYPROMELLOSE 2910 (4000 CPS) - UNII:RN3152OP35) HYPROMELLOSE 2910 (4000 CPS)0.003 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
SODIUM BORATE (UNII: 91MBZ8H3QO)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
BORIC ACID (UNII: R57ZHV85D4)  
WATER (UNII: 059QF0KO0R)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11716-9637-71 in 1 CARTON
115 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34907/12/2010
Labeler - HANLIM PHARM. CO., LTD. (687986034)

Revised: 7/2010
Document Id: 396900be-73f8-4ccf-ab2f-b188b8e80f5c
Set id: 9dba4117-a6e1-40ef-ab9e-b2f21e032766
Version: 2
Effective Time: 20100712
 
HANLIM PHARM. CO., LTD.