Drug Facts

Drug Facts

SPL v3

SPL

SPL Set ID 6a7be1e9-27ff-44d8-85ed-fc1b0017180e

Route

OPHTHALMIC

Published

Effective Date 2024-07-22

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

NDA Active Since 2022-04-01

Description

Ketotifen 0.025% (equivalent to ketotifen fumerate 0.035%)

Purpose

Antihistamine

Medication Information

Purpose

Antihistamine

Description

Ketotifen 0.025% (equivalent to ketotifen fumerate 0.035%)

Uses

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

Warnings

For external use only

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

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
- if using other ophthalmic products while using this product, wait at least 5 minutes between each product
children under 3 years of age:consult a doctor

Active Ingredient

Ketotifen 0.025%

(equivalent to ketotifen fumerate 0.035%)

Other Information

store at 4-25 °C (39-77 °F)

Inactive Ingredients

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

Questions Or Comments?

[phone icon] Call: 1-866-767-8975

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.

Package/label Principal Display Panel

NDC 11822-5533-1

Compare to the

active ingredient in

Systane Zaditor*

EYE ITCH

RELIEF

ketotifen fumarate

ophthalmic solution 0.035%

ANTIHISTAMINE EYE DROPS

up to 12 hours

works in minutes

Original prescription

strength

for ages 3 years and older

STERILE

0.34 FL OZ (10 mL)

9764201

LR60109

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

Structured Label Content

Uses

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

Purpose

Antihistamine

Warnings

For external use only

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

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
- if using other ophthalmic products while using this product, wait at least 5 minutes between each product
children under 3 years of age:consult a doctor

Active Ingredient (Active ingredient)

Ketotifen 0.025%

(equivalent to ketotifen fumerate 0.035%)

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, water for injection

Questions Or Comments? (Questions or comments?)

[phone icon] Call: 1-866-767-8975

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.

Package/label Principal Display Panel (Package/Label Principal Display Panel)

NDC 11822-5533-1

Compare to the

active ingredient in

Systane Zaditor*

EYE ITCH

RELIEF

ketotifen fumarate

ophthalmic solution 0.035%

ANTIHISTAMINE EYE DROPS

up to 12 hours

works in minutes

Original prescription

strength

for ages 3 years and older

STERILE

0.34 FL OZ (10 mL)

9764201

LR60109

Stop Use and Ask A Doctor If You Experience Any of the Following: (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

Advanced Ingredient Data

[{"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": ""}, {"name": "KETOTIFEN", "unii": "X49220T18G", "classCode": "ACTIM", "strengthNumerator": "0.25", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"Uses": "for the temporary relief of itchy eyes due to ragweed, pollen, grass, animal hair and dander.", "Purpose": "Antihistamine", "Warnings": "For external use only 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", "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 if using other ophthalmic products while using this product, wait at least 5 minutes between each product children under 3 years of age: consult a doctor", "Active ingredient": "Ketotifen 0.025% (equivalent to ketotifen fumerate 0.035%)", "Other information": "store at 4-25 °C (39-77 °F)", "Inactive ingredients": "benzalkonium chloride 0.01%, glycerin, hydrochloric acid and/or sodium hydroxide, water for injection", "Questions or comments?": "[phone icon] Call: 1-866-767-8975", "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.", "Package/Label Principal Display Panel": "NDC 11822-5533-1 Compare to the active ingredient in Systane Zaditor * EYE ITCH RELIEF ketotifen fumarate ophthalmic solution 0.035% ANTIHISTAMINE EYE DROPS up to 12 hours works in minutes Original prescription strength for ages 3 years and older STERILE 0.34 FL OZ (10 mL) 9764201 LR60109", "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"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:19.671808 · Updated: 2026-03-14T23:03:20.235753