Eye Itch Relief

Label at a glance#

Contacts and useful links#

PhoneLabel contact1-800-932-5676

PhoneLabel contact1-800-200-6313

Websitewww.myleader.comwww.myleader.com

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

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

Purpose

OTC - PURPOSE SECTION

Antihistamine

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

• 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

OTC - WHEN USING SECTION

• do not touch the tip of container to any surface to avoid contamination
• remove contact lenses before use
• wait at least 10 minutes before reinserting contact lens after use
• replace cap after each use

OTC - STOP USE SECTION

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 more than 72 hours

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

• Adults and children 3 years of age and older: Put 1 drop in the affected eye(s) twice daily, every 8 to 12 hours, no more than twice per day.
• Children under 3 years of age: Consult a doctor

Other information

OTHER SAFETY INFORMATION

• only for use in the eye.
• store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Inactive ingredients

INACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.01%, Glycerin, Water for Injection. May contain Hydrochloric Acid and/or Sodium Hydroxide to adjust pH.

Questions or comments?

OTC - QUESTIONS SECTION

1-800-932-5676

.

SPL UNCLASSIFIED SECTION

*This product is not manufactured or distributed by Alcon Laboratories, distributor of Zaditor®.

CardinalHealth™

DISTRIBUTED BY CARDINAL HEALTH

DUBLIN, OHIO 43017

www.myleader.com 1-800-200-6313

Essential to Care™ since 1979

100% Money Back Guarantee

Return to place of purchase.

2080	CIN 5266457 REV. 11/16	LKAAL Rev. 08/16
	CIN 5266457 REV. 11/16	LKAAC Rev. 08/16

Principal Display Panel Text for Container Label:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LEADER™

NDC 70000-0124-1

Sterile

Eye Itch

Relief

Ketotifen Fumarate Ophthalmic Solution

Antihistamine Eye Drops

5 mL (0.17FL OZ)

Principal Display Panel Text for Carton Label:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LEADER™

NDC 70000-0124-1

Sterile

Eye Itch

Relief

Ketotifen Fumarate Ophthalmic Solution

Antihistamine Eye Drops

Up to 12 Hours

of Itch Relief

Works in Minutes

Original Prescription Strength

For Ages 3 Years & Older

30-day Supply

COMPARE TO ZADITOR® ANTIHISTAMINE EYE DROPS Active ingredient*

100% Money Back Guarantee

5 mL (0.17 FL OZ)

DailyMed RxNorm Mappings#

DailyMed Pharmacologic Classes#

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FDA-Initiated Inactive NDC Indexing#

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Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 8 matching rows.

• Eye Itch Relief
• Ketotifen Fumarate
• KETOTIFEN
• BENZALKONIUM CHLORIDE
• GLYCERIN
• WATER
• HYDROCHLORIC ACID
• SODIUM HYDROXIDE

NDC Codes#

Ingredients#

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DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Source Document#

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