LEADER EYE ITCH RELIEF DROPS- ketotifen fumarate solution/ drops

LEADER EYE ITCH RELIEF DROPS by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient                                             Purpose

Ketotifen (0.025%)..........................................Antihistamine

(Equivalent to ketotifen fumarate 0.035%)

PURPOSE

Use

Temporarily relieves itchy eyes due to pollen, ragweed, grass, animal hair and dander.

DO NOT USE

Warnings

Do not use

• if solution changes color or becomes cloudy
• if you are sensitive to any ingredient in this product
• to treat contact lens related irritation
  

WHEN USING

When using this product

• do not touch tip of container to any surface to avoid contamination
• remove contact lenses before use
• wait at least 10 minutes before reinserting contact lenses after use
• replace cap after each use
  

STOP USE

Stop use and ask a doctor if you experience any of the following:

• eye pain
  
• changes in vision
• redness of the eye
• itching worsens or lasts 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 right away.

INDICATIONS & USAGE

Directions

• Adults and children 3 years of age and older: Put 1 drop in the affected eye(s) twice daily, every 8-12 hours, no more than twice per day
• Children under 3 years of age: Consult a doctor
  

STORAGE AND HANDLING

Other information

• Only for use in the eye
• Store between 20o-25oC (68o to 77oF) (See USP controlled Room Temperature)
• Do not use if cap seal ring is broken

INACTIVE INGREDIENT

Inactive ingredients

benzalkonium chloride 0.01%, glycerol, sodium hydroxide and/or hydrochloric acid, and water for injection

PRINCIPAL DISPLAY PANEL

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INGREDIENTS AND APPEARANCE

LEADER EYE ITCH RELIEF DROPS 
ketotifen fumarate solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11716-1163
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
KETOTIFEN FUMARATE (UNII: HBD503WORO) (KETOTIFEN - UNII:X49220T18G)	KETOTIFEN FUMARATE	0.345 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11716-1163-7	1 in 1 CARTON
1		5 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part349	04/21/2010

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

Registrant - UNITED EXCHANGE CORP. (840130579)