ALLERGY RELIEF EYE - ketotifen fumarate solution/ drops
Western Family Foods 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

Principal Display Panel

Allergy Relief Eye Drops

Ketotifen Fumarate Ophthalmic Solution

Antihistamine Eye Drops

Up to 12 Hours

Allergy Eye Itch Relief

Works In Minutes

Contains the drug Ketotifen Fumarate

For Ages 3 Years & Older

30 Day Supply

Sterile

Compare To Claritin® Eye active ingredient

Allergy Relief Eye Drops Carton

ALLERGY RELIEF EYE
ketotifen fumarate solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55312-027
Route of Administration	OPHTHALMIC	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
KETOTIFEN FUMARATE (KETOTIFEN)	KETOTIFEN FUMARATE	0.035 mL in 100 mL

Inactive Ingredients
Ingredient Name	Strength
BENZALKONIUM CHLORIDE
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:55312-027-01	1 BOTTLE ( BOTTLE) in 1 CARTON	contains a BOTTLE
1		5 mL in 1 BOTTLE	This package is contained within the CARTON (55312-027-01)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA077958	05/25/2011

Labeler - Western Family Foods Inc (192166072)

Revised: 05/2011 Western Family Foods Inc