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

Purpose

Antihistamine (equivalent to ketotifen fumarate 0.035%)

Description

Ketotifen (0.025%)

Medication Information

Uses

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

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

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.

Description

Ketotifen (0.025%)

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

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%)

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.

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

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.

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

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%)

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

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