Zaditor (Ketotifen Fumarate) Solution [Alcon Laboratories, Inc.] -

ZADITOR (KETOTIFEN FUMARATE) SOLUTION [ALCON LABORATORIES, INC.]
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NDC	0065-4011-05, 0065-4011-06
Set ID	ac66b1e4-c2b0-a4c3-09e3-ebd44a2f7c9f
Category	HUMAN OTC DRUG LABEL
Packager	Alcon Laboratories, Inc.
Generic Name
Product Class
Product Number
Application Number	ANDA077200

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ACTIVE INGREDIENT

Active ingredient Purpose
Ketotifen (0.025%)
(equivalent to ketotifen fumarate 0.035%) Antihistamine

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INDICATIONS & USAGE

Use Temporarily relieves itchy eyes due to pollen, ragweed, grass, animal hair and dander.
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Warnings
For external use only
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
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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
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STOP 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
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KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
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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
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Other information
- Only for use in the eye.
- Store between 4°-25°C (39°-77°F).
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Inactive ingredients

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

call toll-free
1-800-757-9195
MedInfo@Alcon.com
www.zaditor.com

Serious side effects associated with use of this product may be reported to this number.
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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

New Look   SAME FORMULA

Systane®
ZADITOR

ketotifen fumarate ophthalmic solution 0.035%

ANTIHISTAMINE EYE DROPS

up to 12 HOURS EYE ITCH RELIEF

●   Works in minutes
●   Original prescription strength
●   For ages 3 years and older

5 mL (0.17 FL OZ)

STERILE

30 DAY SUPPLY

Alcon®

TAMPER EVIDENT: For your protection, this bottle has a seal imprinted with Alcon around the neck. Do not use if seal is damaged or missing at time of purchase.

Alcon Laboratories, Inc.
6201 South Freeway
Fort Worth, TX 76134 USA
© 2009, 2012, 2016 Novartis

9013176-0416

ACTUAL SIZE

LOT:          EXP.:

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INGREDIENTS AND APPEARANCE

ZADITOR
ketotifen fumarate solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0065-4011
Route of Administration	OPHTHALMIC

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Ketotifen Fumarate (UNII: HBD503WORO) (Ketotifen - UNII:X49220T18G)	Ketotifen	.25 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
Benzalkonium Chloride (UNII: F5UM2KM3W7)
Glycerin (UNII: PDC6A3C0OX)
Sodium Hydroxide (UNII: 55X04QC32I)
Hydrochloric Acid (UNII: QTT17582CB)
Water (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0065-4011-05	1 in 1 CARTON	12/21/2012
1		5 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2	NDC:0065-4011-06	2 in 1 CARTON	12/21/2012
2		5 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product