LEADER LUBRICANT EYE DROPS - polyethylene glycol 400 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.

----------

Drug Facts

Active ingredients-------------------------------------------------Purpose

Polyethylene Glycol 400 (0.4%)-----------------------------Lubricant

Propylene Glycol (0.3%)---------------------------------------Lubricant

Uses

For the temporary relief of burning and irritation due to eye dryness.

Warnings

For external use only.

Do not use

When using this product

Stop use and ask a doctor if

Keep out of reach of children.

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

Directions

Inactive ingredients: Boric Acid, Calcium Chloride, Chlorhexidine Gluconate, Hydrochloric Acid, Hydroxypropyl Guar,

Magnesium Chloride, Potassium Chloride, Purified Water, Sodium Chloride, Zinc Chloride

image of carton labelEnter section text here

LEADER LUBRICANT EYE DROPS 
polyethylene glycol 400 solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11716-1192
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) (POLYETHYLENE GLYCOL - UNII:3WJQ0SDW1A) POLYETHYLENE GLYCOL 4000.4 mL  in 1 mL
PROPYLENE GLYCOL (UNII: 6DC9Q167V3) (PROPYLENE GLYCOL - UNII:6DC9Q167V3) PROPYLENE GLYCOL0.3 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BORIC ACID (UNII: R57ZHV85D4)  
CALCIUM CHLORIDE (UNII: M4I0D6VV5M)  
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E)  
HYDROCHLORIC ACID (UNII: QTT17582CB)  
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
WATER (UNII: 059QF0KO0R)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
ZINC CHLORIDE (UNII: 86Q357L16B)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11716-1192-61 in 1 CARTON
115 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34904/28/2010
Labeler - HANLIM PHARM. CO., LTD. (687986034)

Revised: 4/2010
Document Id: 8a2dd2b4-e592-41a3-995f-c70427015383
Set id: dcec9de2-d680-4829-9557-7ace9f506a3b
Version: 5
Effective Time: 20100428
 
HANLIM PHARM. CO., LTD.