Drug Facts

Drug Facts

SPL v3

SPL

SPL Set ID 2bdc00ed-be10-4e1f-b164-3e92dd8f63cd

Route

OPHTHALMIC

Published

Effective Date 2014-09-23

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Ketotifen (0.25 mg)

Inactive Ingredients

Benzalkonium Chloride Glycerin Hydrochloric Acid Sodium Hydroxide Water

Identifiers & Packaging

Marketing Status

ANDA Active Since 2012-05-01

Description

Ketotifen (0.025%)

Purpose

Antihistamine (equivalent to ketotifen fumarate 0.035%)

Medication Information

Purpose

Antihistamine

(equivalent to ketotifen fumarate 0.035%)

Description

Ketotifen (0.025%)

Uses

For the temporary relief of itchy eyes due to ragweed, pollen, grass, animal hair and dander.

Section 50566-9

Stop use and ask a doctor if you experience any of the following:

•
eye pain
•
changes in vision
•
redness of the eyes
•
itching that worsens or lasts for more than 72 hours

Section 51945-4

Principal Display Panel

Well at

Walgreens

WALGREENS PHARMACIST RECOMMENDED^‡

STERILE

ORIGINAL

PRESCRIPTION STRENGTH

Eye Itch

Relief

Ketotifen Fumarate

Ophthalmic Solution

Antihistamine Eye Drops

•
Works in minutes
•
For ages 3 years & older
•
30-day supply

0.17 FL OZ (5 mL)

12 UP TO 12 HOURS

Compare to Zaditor^®active ingredient^‡‡

Section 53413-1

Questions or comments?

Toll Free Product Information

Call: 1-800-553-5340

DISTRIBUTED BY: WALGREEN CO.

200 WILMOT RD., DEERFIELD, IL 60015

100% SATISFACTION GUARANTEED

MADE IN U.S.A.

ITEM 306486

9323100

FU60107

Directions

•
Adults and children 3 years 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

Do Not Use

•
if you are sensitive to any ingredient in this product
•
if solution changes color or becomes cloudy
•
to treat contact lens related irritation

Active Ingredient

Ketotifen (0.025%)

Other Information

•
store at 4-25°C (39-77°F)

Inactive Ingredients

benzalkonium chloride 0.01%, glycerin, hydrochloric acid and/or sodium hydroxide and water for injection.

When Using This Product

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

Keep Out of Reach of Children.

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

Structured Label Content

Uses

For the temporary relief of itchy eyes due to ragweed, pollen, grass, animal hair and dander.

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 eyes
•
itching that worsens or lasts for more than 72 hours

Section 51945-4 (51945-4)

Principal Display Panel

Well at

Walgreens

WALGREENS PHARMACIST RECOMMENDED^‡

STERILE

ORIGINAL

PRESCRIPTION STRENGTH

Eye Itch

Relief

Ketotifen Fumarate

Ophthalmic Solution

Antihistamine Eye Drops

•
Works in minutes
•
For ages 3 years & older
•
30-day supply

0.17 FL OZ (5 mL)

12 UP TO 12 HOURS

Compare to Zaditor^®active ingredient^‡‡

Section 53413-1 (53413-1)

Questions or comments?

Toll Free Product Information

Call: 1-800-553-5340

DISTRIBUTED BY: WALGREEN CO.

200 WILMOT RD., DEERFIELD, IL 60015

100% SATISFACTION GUARANTEED

MADE IN U.S.A.

ITEM 306486

9323100

FU60107

Purpose

Antihistamine

(equivalent to ketotifen fumarate 0.035%)

Directions

•
Adults and children 3 years 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

Do Not Use (Do not use)

•
if you are sensitive to any ingredient in this product
•
if solution changes color or becomes cloudy
•
to treat contact lens related irritation

Active Ingredient (Active ingredient)

Ketotifen (0.025%)

Other Information (Other information)

•
store at 4-25°C (39-77°F)

Inactive Ingredients (Inactive ingredients)

benzalkonium chloride 0.01%, glycerin, hydrochloric acid and/or sodium hydroxide and water for injection.

When Using This Product (When using this product)

•
remove contact lenses before use
•
wait at least 10 minutes before re-inserting contact lenses after use
•
do not touch tip of container to any surface to avoid contamination
•
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.

Advanced Ingredient Data

[{"name": "KETOTIFEN", "unii": "X49220T18G", "classCode": "ACTIM", "strengthNumerator": "0.25", "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": "Hydrochloric Acid", "unii": "QTT17582CB", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Sodium Hydroxide", "unii": "55X04QC32I", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Water", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "For the temporary relief of itchy eyes due to ragweed, pollen, grass, animal hair and dander.", "50566-9": "Stop use and ask a doctor if you experience any of the following: • eye pain • changes in vision • redness of the eyes • itching that worsens or lasts for more than 72 hours", "51945-4": "Principal Display Panel Well at Walgreens WALGREENS PHARMACIST RECOMMENDED ‡ STERILE ORIGINAL PRESCRIPTION STRENGTH Eye Itch Relief Ketotifen Fumarate Ophthalmic Solution Antihistamine Eye Drops • Works in minutes • For ages 3 years & older • 30-day supply 0.17 FL OZ (5 mL) 12 UP TO 12 HOURS Compare to Zaditor ® active ingredient ‡‡", "53413-1": "Questions or comments? Toll Free Product Information Call: 1-800-553-5340 DISTRIBUTED BY: WALGREEN CO. 200 WILMOT RD., DEERFIELD, IL 60015 100% SATISFACTION GUARANTEED walgreens.com ©2013 Walgreen Co. MADE IN U.S.A . ITEM 306486 9323100 FU60107", "Purpose": "Antihistamine (equivalent to ketotifen fumarate 0.035%)", "Directions": "• Adults and children 3 years 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", "Do not use": "• if you are sensitive to any ingredient in this product • if solution changes color or becomes cloudy • to treat contact lens related irritation", "Active ingredient": "Ketotifen (0.025%)", "Other information": "• store at 4-25°C (39-77°F)", "Inactive ingredients": "benzalkonium chloride 0.01%, glycerin, hydrochloric acid and/or sodium hydroxide and water for injection.", "When using this product": "• remove contact lenses before use • wait at least 10 minutes before re-inserting contact lenses after use • do not touch tip of container to any surface to avoid contamination • replace cap after each use", "Keep out of reach of children.": "If swallowed, get medical help or contact a Poison Control Center right away."}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:55:50.401177 · Updated: 2026-03-14T22:53:48.902596