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ZADITOR by Alcon Laboratories, Inc.

Dosage form: solution
Ingredients: Ketotifen Fumarate .35mg in 1mL
Labeler: Alcon Laboratories, Inc.
NDC Code: 0065-0333

ZADITOR®
ANTIHISTAMINE EYE DROPS

DRUG FACTS

OTC - ACTIVE INGREDIENT SECTION

Ketotifen (0.025%)
(equivalent to ketotifen fumarate 0.035%)

OTC - PURPOSE SECTION

Antihistamine

INDICATIONS & USAGE SECTION

Temporarily relieves itchy eyes due to pollen, ragweed, grass, animal hair and dander.

WARNINGS SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

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 between 4°-25°C (39°-77°F).

INACTIVE INGREDIENT SECTION

benzalkonium chloride 0.01%, glycerol, sodium hydroxide and/or hydrochloric acid, and purified water

QUESTIONS?

call toll-free
1-866-393-6336, weekdays, 8:30 AM - 5:00 PM EST.
Serious side effects associated with use of this product may be reported to this number.

PRINCIPAL DISPLAY PANEL

NDC 0065-0333-05
STERILE

ZADITOR®
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)

Alcon®

ZADITOR
ketotifen fumarate solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0065-0333
Route of Administration	OPHTHALMIC	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Ketotifen Fumarate (Ketotifen)	Ketotifen Fumarate	.35 mg in 1 mL

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

Packaging
#	Item Code	Package Description
1	NDC:0065-0333-05	1 BOTTLE, DROPPER (BOTTLE) in 1 CARTON
1		5 mL in 1 BOTTLE, DROPPER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA021066	09/22/2009

Labeler - Alcon Laboratories, Inc. (008018525)

Registrant - Alcon Laboratories, Inc. (008018525)

Establishment
Name	Address	ID/FEI	Operations
CIBA Vision Canada, Inc.		247191463	MANUFACTURE

Revised: 03/2012

Document Id: 7bb0d74e-7db8-5fd2-193e-cd1540ed6f7a

Set id: 3c149d1c-1f43-6387-a8ce-08042abcb920

Version: 1

Effective Time: 20120302

Alcon Laboratories, Inc.

← See all ZADITOR brands

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

ZADITOR by Alcon Laboratories, Inc.

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