LEADER LUBRICATING EYE DROPS- carboxymethylcellulose sodium solution

LEADER LUBRICATING EYE DROPS by

Drug Labeling and Warnings

LEADER LUBRICATING EYE DROPS by is a Otc medication manufactured, distributed, or labeled by HANLIM PHARM. CO., LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

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

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

PURPOSE

Uses

• For the temporary relief of burning, irritation and discomfort due to dryness of the eye or from irritation from wind or sun.
• May be used to protect against further irritation.
  

WARNINGS

Warnings

• For external use only

WHEN USING

When using this product

• To avoid contamination, do not touch tip of container to any surface.  Replace cap after using.
• Do not use if solution changes color or gets cloudy.
  

STOP USE

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

Keep out of reach of children.

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

INDICATIONS & USAGE

Directions

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

INACTIVE INGREDIENT

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

PRINCIPAL DISPLAY PANEL

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INGREDIENTS AND APPEARANCE

LEADER LUBRICATING EYE DROPS 
carboxymethylcellulose sodium solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11716-1191
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) (CARBOXYMETHYLCELLULOSE - UNII:05JZI7B19X)	CARBOXYMETHYLCELLULOSE SODIUM	5 mg  in 1 mL
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	9 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11716-1191-5	1 in 1 CARTON
1		15 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part349	04/29/2010

Labeler - HANLIM PHARM. CO., LTD. (687986034)