EYE ITCH RELIEF- ketotifen fumarate solution 
Meijer Distribution Inc

----------

Meijer Distribution, Inc. 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

Original Prescription Strength

Eye Itch Relief

Ketotifen Fumarate Ophthalmic Solution

Antihistamine Eye Drops

Up to 12 Hours

Works in Minutes

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

Eye Itch Relief Carton Image 1

Eye Itch Relief Carton Image 2

EYE ITCH RELIEF 
ketotifen fumarate solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41250-923
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
KETOTIFEN FUMARATE (UNII: HBD503WORO) (KETOTIFEN - UNII:X49220T18G) KETOTIFEN0.25 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
HYDROCHLORIC ACID (UNII: QTT17582CB)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41250-923-011 in 1 CARTON08/23/201006/01/2015
15 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07795808/23/201006/01/2015
Labeler - Meijer Distribution Inc (006959555)

Revised: 11/2017
Document Id: e1847403-7478-4ad1-bcae-865071a08911
Set id: def3cc8c-41cf-4cf9-83fa-b0bcc92c9203
Version: 3
Effective Time: 20171116
 
Meijer Distribution Inc