EYE ITCH RELIEF- ketotifen fumarate solution 
Walgreen Company

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Walgreen Co. Eye Itch Relief Drug Facts

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

  • 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.

Other information

  • only for use in the eye
  • store at 20-25°C (68-77°F) [see USP Controlled Room Temperature]

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 Zaditor® active ingredient

EYE ITCH RELIEF

KETOTIFEN FUMARATE OPHTHALMIC SOLUTION

ANTIHISTAMINE EYE DROPS

UP TO 12 HOURS

Works in Minutes

Original Prescription Strength

For Ages 3 Years and Older

30 Day Supply

Sterile

Eye Itch Relief Carton Image 1

Eye Itch Relief Carton Image 1

Eye Itch Relief Carton Image 2

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EYE ITCH RELIEF 
ketotifen fumarate solution
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:0363-0923
Route of AdministrationOPHTHALMICDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
KETOTIFEN FUMARATE (KETOTIFEN) KETOTIFEN0.25 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN 
WATER 
HYDROCHLORIC ACID 
SODIUM HYDROXIDE 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0363-0923-011 in 1 CARTON
15 mL in 1 BOTTLE
2NDC:0363-0923-112 in 1 CARTON
25 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07795808/13/2010
Labeler - Walgreen Company (008965063)

Revised: 6/2012
Document Id: 20357795-3371-4e02-ba85-86cd8e458e22
Set id: 86e807cb-fd3f-4a55-bff4-54b10ec528a9
Version: 2
Effective Time: 20120605
 
Walgreen Company