ITCHY EYE ORIGINAL PRESCRIPTION STRENGTH - ketotifen solution
Meijer Distribution Inc

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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 Zyrtec® Itchy Eye Drops active ingredient

Original Prescription Strength

Itchy Eye Drops

Ketotifen Fumarate Ophthalmic Solution

Antihistamine Eye Drops

Up to 12 Hours

Works in Minutes

For ages 3 years and older

30 day supply

Sterile

Itchy Eye Drops Carton Image 1

Itchy Eye Drops Carton Image 2

ITCHY EYE ORIGINAL PRESCRIPTION STRENGTH
ketotifen solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:41250-615
Route of Administration	OPHTHALMIC	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
KETOTIFEN (KETOTIFEN)	KETOTIFEN	0.025 mL in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN
WATER
HYDROCHLORIC ACID
SODIUM HYDROXIDE

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:41250-615-01	1 BOTTLE ( BOTTLE) in 1 CARTON	contains a BOTTLE
1		5 mL in 1 BOTTLE	This package is contained within the CARTON (41250-615-01)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA077958	08/23/2010

Labeler - Meijer Distribution Inc (006959555)

Revised: 11/2010 Meijer Distribution Inc