ITCHY EYE- ketotifen solution 
Kroger Company

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Kroger Co. Itchy Eye Drops 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?

1-800-632-6900

Package/Label Principal Display Panel

UP TO 12 HOURS

COMPARE TO active ingredient of ZYRTEC® ITCHY EYE DROPS

See back panel

Itchy Eye Drops

Ketotifen Fumerate Opthalmic Solution

Antihistamine Eye Drops

Allergy Eye Relief

Original Prescription Strength

Works in Minutes

For Ages 3 Yrs. & Older

# Day Supply {Replace "#" with amount of day supply}

Sterile

Itchy Eye Drops Package

Itchy Eye Drops Package

Itchy Eye Drops Package

ITCHY EYE 
ketotifen solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:30142-615
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:30142-615-011 in 1 PACKAGE05/27/201106/01/2015
15 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07795805/27/201106/01/2015
Labeler - Kroger Company (006999528)

Revised: 11/2017
Document Id: 7b25d437-c6d3-449b-9ad7-78e3df402dd2
Set id: a1cc08a6-cfee-406f-b9c5-df5a5e7aca1d
Version: 3
Effective Time: 20171115
 
Kroger Company