ITCHY EYE - ketotifen solution 
Major Pharmaceuticals

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Active ingredient

Ketotifen (0.025%) (equivalent to ketotifen fumarate 0.035%)

Purpose

Antihistamine

Uses

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

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 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 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.

If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions

Put 1 drop in the affected eye(s) twice daily, every 8-12 hours, no more than twice per day.

Consult a doctor.

Other information

Inactive ingredients

benzalkonium chloride 0.01%, glycerin, purified water. May contain hydrochloric acid and/or sodium hydroxide (to adjust pH).

Questions or comments?

1-800-719-9260

Package/Label Principal Display Panel

Compare to active ingredient of Zyrtec® Itchy Eye Drops

Itchy Eye Drops

Ketotifen Fumarate Ophthalmic Solution

Antihistamine Eye Drops

UP TO 12 HOURS

ALLERGY ITCHY EYE RELIEF

WORKS IN MINUTES

For Ages 3 Yrs. & Older

30 Day Supply

Original Prescription Strength

Sterile

Itchy Eye Drops Carton Image 1

Itchy Eye Drops Carton Image 1

Itchy Eye Drops Carton Image 2

Itchy Eye Drops Carton Image 2


ITCHY EYE 
ketotifen solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-5837
Route of AdministrationOPHTHALMICDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
KETOTIFEN (KETOTIFEN) KETOTIFEN0.025 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN 
WATER 
HYDROCHLORIC ACID 
SODIUM HYDROXIDE 
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:0904-5837-051 BOTTLE ( BOTTLE) in 1 CARTONcontains a BOTTLE
15 mL in 1 BOTTLEThis package is contained within the CARTON (0904-5837-05)

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07795811/16/2010

Labeler - Major Pharmaceuticals (191427277)

Revised: 11/2011 Major Pharmaceuticals