LEADER LUBRICANT EYE DROPS- polyethylene glycol 400 solution

LEADER LUBRICANT EYE DROPS by

Drug Labeling and Warnings

LEADER LUBRICANT 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

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

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

PURPOSE

Uses

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

WARNINGS

Warnings

For external use only.

DO NOT USE

Do not use

• if solution changes color or becomes cloudy
• if you are sensitive or allergic to any ingredient in this product
  

WHEN USING

When using this product

• to avoid contamination, do not touch tip of container to any surface
• replace cap after each use
  

STOP USE

Stop use and ask a doctor if

• you experience eye pain
• changes in vision occur
• redness or irritation of the eye(s) gets worse or lasts 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, Chlorhexidine Gluconate, Hydrochloric Acid, Hydroxypropyl Guar,

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

PRINCIPAL DISPLAY PANEL

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INGREDIENTS AND APPEARANCE

LEADER LUBRICANT EYE DROPS 
polyethylene glycol 400 solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11716-1192
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) (POLYETHYLENE GLYCOL - UNII:3WJQ0SDW1A)	POLYETHYLENE GLYCOL 400	0.4 mL  in 1 mL
PROPYLENE GLYCOL (UNII: 6DC9Q167V3) (PROPYLENE GLYCOL - UNII:6DC9Q167V3)	PROPYLENE GLYCOL	0.3 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11716-1192-6	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	04/28/2010

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