DailyMed - DailyMed Details

Drug Facts

Composition & Product

Active Ingredients

Ketotifen (0.35 mg)

Inactive Ingredients

Benzalkonium Chloride Glycerin Water

Identifiers & Packaging

Marketing Status

ANDA Completed Since 2017-01-18 Until 2028-03-31

Medication Information

Purpose

Antihistamine

Description

Drug Facts

.

*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

Uses

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

Section 42229-5

Drug Facts

Section 50566-9

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

Directions

▪
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

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

Active Ingredient

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

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, Water for Injection. May contain Hydrochloric Acid and/or Sodium Hydroxide to adjust pH.

Questions Or Comments?

1-800-932-5676

When Using This Product

▪
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

Keep Out of Reach of Children

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

Principal Display Panel Text for Carton Label:

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)

Principal Display Panel Text for Container Label:

LEADER™

NDC 70000-0124-1

Sterile

Eye Itch

Relief

Ketotifen Fumarate Ophthalmic Solution

Antihistamine Eye Drops

5 mL (0.17FL OZ)

Structured Label Content

.

*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

Uses

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

Section 42229-5 (42229-5)

Drug Facts

Section 50566-9 (50566-9)

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

Purpose

Antihistamine

Directions

▪
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

Do Not Use (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

Active Ingredient

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

Other Information (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 (Inactive ingredients)

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

Questions Or Comments? (Questions or comments?)

1-800-932-5676

When Using This Product (When using this product)

▪
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

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.

Principal Display Panel Text for Carton Label:

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)

Principal Display Panel Text for Container Label:

LEADER™

NDC 70000-0124-1

Sterile

Eye Itch

Relief

Ketotifen Fumarate Ophthalmic Solution

Antihistamine Eye Drops

5 mL (0.17FL OZ)

Advanced Ingredient Data

[{"name": "KETOTIFEN", "unii": "X49220T18G", "classCode": "ACTIM", "strengthNumerator": "0.35", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "BENZALKONIUM CHLORIDE", "unii": "F5UM2KM3W7", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYDROCHLORIC ACID", "unii": "QTT17582CB", "classCode": "CNTM", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM HYDROXIDE", "unii": "55X04QC32I", "classCode": "CNTM", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{".": "*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", "Uses": "Temporarily relieves itchy eyes due to pollen, ragweed, grass, animal hair and dander.", "42229-5": "Drug Facts", "50566-9": "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", "Purpose": "Antihistamine", "Directions": "▪ 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", "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", "Active Ingredient": "Ketotifen (0.025%) (equivalent to ketotifen fumarate 0.035%)", "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, Water for Injection. May contain Hydrochloric Acid and/or Sodium Hydroxide to adjust pH.", "Questions or comments?": "1-800-932-5676", "When using this product": "▪ 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", "Keep out of reach of children": "If swallowed, get medical help or contact a Poison Control Center right away.", "Principal Display Panel Text for Carton Label:": "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)", "Principal Display Panel Text for Container Label:": "LEADER™ NDC 70000-0124-1 Sterile Eye Itch Relief Ketotifen Fumarate Ophthalmic Solution Antihistamine Eye Drops 5 mL (0.17FL OZ)"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information