Active ingredient

Ketotifen (0.025%)

(equivalent to Ketotifen Fumarate 0.035%)

Purpose

Antihistamine

Use

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.

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° to 25°C (68° TO 77°F) [see USP Controlled Room Temperature].

Inactive ingredients

Benzalkonium Chloride 0.01%; Glycerin and Purified Water. May contain Hydrochloric Add and/or Sodium Hydroxide (to adjust pH).

Questions?

call toll-free 1-800-932-5676, weekdays, 7:00 AM - 5:30 PM CST

Principal Display Panel Text for Container Label:

NDC 17478-717-10

Ketotifen Fumarate

Ophthalmic Solution

ANTIHISTAMINE EYE DROPS

5 mL (0.17 FL OZ) Sterile

Principal Display Panel Text for Container Label

Principal Display Panel Text for Carton Label:

Now OTC! NDC 17478-060-12

Akorn Logo

Ketotifen

Fumarate

Ophthalmic

Solution

ANTIHISTAMINE EYE DROPS

UP TO 12 HOURS EYE ITCH RELIEF

Works in Minutes

Original Prescription Strength

FOR AGES 3 YEARS AND OLDER

30 DAY SUPPLY

5 mL (0.17 FL OZ) Sterile

Principal Display Panel Text for Carton Label

KETOTIFEN FUMARATE
ketotifen fumarate solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:17478-717
Route of Administration	OPHTHALMIC	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Ketotifen Fumarate (Ketotifen)	Ketotifen Fumarate	0.35 mg in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Glycerin
Sodium Hydroxide
Hydrochloric Acid
Water
Benzalkonium Chloride

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:17478-717-10	1 BOTTLE, DROPPER (1 BOTTLE) in 1 CARTON	contains a BOTTLE, DROPPER
1		5 mL in 1 BOTTLE, DROPPER	This package is contained within the CARTON (17478-717-10)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA077958	10/01/2007

Labeler - Akorn, Inc. (062649876)

Establishment
Name	Address	ID/FEI	Operations
Akorn, Inc.		603980319	MANUFACTURE, REPACK, ANALYSIS, LABEL, PACK, RELABEL, STERILIZE

Revised: 12/2011 Akorn, Inc.