LEADER DRY EYE RELIEF- dextran 70 solution

LEADER DRY EYE RELIEF by

Drug Labeling and Warnings

LEADER DRY EYE RELIEF 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

Dextran 70 (0.1%).........................................................................(Lubricant)

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

PURPOSE

Uses

• for the temporary relief of burning and irritation of the eye and for use as a protectant against further irritation.
• for the temporary relief of discomfort due to minor irritations of the eye or to exposure to wind or sun.
  

WARNINGS

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

When using this product

• remove contact lenses before using
• do not touch tip of container to any surface to avoid contamination
• replace cap after each use
  

STOP USE

Stop use and ask a doctor if

• you feel pain
  
• changes in vision occur
• redness or irritation of the eye gets worse or lasts more than 72 hours
  

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding,

ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

Keep out of the reach of children.

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

INDICATIONS & USAGE

Directions

• Instill 1 or 2 drops in the affected eye(s) as needed.
• Store at room temperature
  

INACTIVE INGREDIENT

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

PRINCIPAL DISPLAY PANEL

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INGREDIENTS AND APPEARANCE

LEADER DRY EYE RELIEF 
dextran 70 solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11716-9637
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTRAN 70 (UNII: 7SA290YK68) (DEXTRAN 70 - UNII:7SA290YK68)	DEXTRAN 70	0.001 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 Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11716-9637-7	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	07/12/2010

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