KETOTIFEN FUMARATE- ketotifen fumarate solution/ drops 
Walgreens

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Drug Facts

Active ingredient

Ketotifen (0.025%)

(equivalent to ketotifen fumarate 0.035%)

Purpose

Antihistamine

Uses

For the temporary relief of itchy eyes due to ragweed, pollen, grass, animal hair and dander.

Warnings

Do not use

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

When using this product

remove contact lenses before use
wait at least 10 minutes before re-inserting contact lenses after use
do not touch tip of container to any surface to avoid contamination
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 s
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.

Directions

Adults and children 3 years 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

Store at 4-25°C (39-77°F)

Inactive ingredients

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

Questions or comments?

Toll Free Product Information

Call:1-800-553-5340

DISTRIBUTED BY: WALGREEN CO.

200 WILMOT RD., DEERFIELD, IL 60015

100% SATISFACTION GUARANTEED

walgreens.com ©2013 Walgreen Co.

MADE IN U.S.A.

ITEM 306487

9323200

FU60109

Principal Display Panel

VALUE SIZE

Well at

Walgreens

WALGREENS PHARMACIST RECOMMENDED≠

STERILE

ORIGINAL

PRESCRIPTION STRENGTH

Eye Itch

Relief

Ketotifen Fumarate

Ophthalmic Solution

Antihistamine Eye Drops

Works in minutes
For ages 3 years & older
60-day supply

UP TO 12 HOURS

0.34 FL OZ (10 mL)

Compare to Zaditor® active ingredient#

Walgreens Eye Itch Relief Carton 10mL
KETOTIFEN FUMARATE 
ketotifen fumarate solution/ drops
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-9060
Route of Administration OPHTHALMIC DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
KETOTIFEN FUMARATE (UNII: HBD503WORO) (Ketotifen - UNII:X49220T18G) Ketotifen 0.25 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
benzalkonium chloride (UNII: F5UM2KM3W7)  
glycerin (UNII: PDC6A3C0OX)  
hydrochloric acid (UNII: QTT17582CB)  
sodium hydroxide (UNII: 55X04QC32I)  
water (UNII: 059QF0KO0R)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0363-9060-00 1 in 1 CARTON
1 10 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077958 01/25/2013
Labeler - Walgreens (008965063)
Registrant - Akorn, Inc. (062649876)
Establishment
Name Address ID/FEI Business Operations
Akorn, Inc 603980319 MANUFACTURE(0363-9060) , ANALYSIS(0363-9060) , STERILIZE(0363-9060) , PACK(0363-9060) , LABEL(0363-9060)

Revised: 9/2014
Document Id: 1c533cbe-1e24-42d7-9572-0e8d31481a75
Set id: 1a59d294-5eb4-43e9-b48e-42c4fbd05498
Version: 4
Effective Time: 20140926
 
Walgreens