ITCHY EYE- ketotifen solution 
H E B

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HEB 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

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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:

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eye pain
•
changes in vision
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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

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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

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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 ZYRTEC® ITCHY EYE DROPS active ingredient

Itchy Eye Drops

Ketotifen Fumarate Opthalmic Solution

Antihistamine Eye Drops

ALLERGY ITCHY EYE RELIEF

Up To 12 Hours

WORKS IN MINUTES

ORIGINAL PRESCRIPTION STRENGTH

For Ages 3 Years & Older

30 Day Supply

STERILE

Itchy Eye Drops Carton Image 1

Itchy Eye Drops Carton Image 1

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Itchy Eye Drops Carton Image 2

ITCHY EYE 
ketotifen solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37808-615
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)  
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:37808-615-011 in 1 CARTON09/15/201001/01/2015
15 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07795809/15/201001/01/2015
Labeler - H E B (007924756)

Revised: 11/2017
Document Id: 30c0f2fc-b405-44c3-8b15-50e8b80f7af9
Set id: 27c98e1a-7600-4006-8041-b23d520841c4
Version: 3
Effective Time: 20171118
 
H E B