LEADER LUBRICATING EYE DROPS - carboxymethylcellulose sodium 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

Carboxymethylcellulose Sodium 0.5%-------------------Lubricant

Glycerin 0.9%-----------------------------------------------------Lubricnat

Uses

Warnings

When using this product

Stop use and ask a doctor if

You feel eye pain, changes in vision, continued redness, or irritation of the eye, or if the condition worsens or persists for more than 72 hours.

Keep out of reach of children.

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

Directions

Put 1 or 2 drops in the affected eye/s as needed.

Inactive ingredients: Boric Acid, Calcium Chloride Dihydrate, Chlorhexidine Gluconate, Erythritol, Hexahydrate, Levocarnitine, Magnesium Chloride, Potassium Chloride, Purified Water, Sodium Borate Decahydrate, Sodium Citrate Dihydrate

image of carton labelEnter section text here

LEADER LUBRICATING EYE DROPS 
carboxymethylcellulose sodium solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11716-1191
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) (CARBOXYMETHYLCELLULOSE - UNII:05JZI7B19X) CARBOXYMETHYLCELLULOSE SODIUM5 mg  in 1 mL
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN9 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BORIC ACID (UNII: R57ZHV85D4)  
CALCIUM CHLORIDE (UNII: M4I0D6VV5M)  
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E)  
ERYTHRITOL (UNII: RA96B954X6)  
LEVOCARNITINE (UNII: 0G389FZZ9M)  
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11716-1191-51 in 1 CARTON
115 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34904/29/2010
Labeler - HANLIM PHARM. CO., LTD. (687986034)

Revised: 4/2010
Document Id: 9659dafe-c8e5-4bc9-89c7-a7c691cf29d0
Set id: 907b73a3-b924-4cb0-a775-b6a09c202c4e
Version: 1
Effective Time: 20100429
 
HANLIM PHARM. CO., LTD.