Drug Facts

Drug Facts

SPL v5

SPL

SPL Set ID 5fccbb63-7859-484c-b7b3-9de711364c09

Route

OPHTHALMIC

Published

Effective Date 2024-05-16

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 2014-08-20

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.

Warnings

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

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

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

Questions?

{Phone icon} Call: 1-800-459-7043

*This product is not manufactured or distributed by Alcon owner of the trademarks Systane and ZADITOR.

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, water for injection

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

Keep Out of Reach of Children.

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

Package/label Principal Display Panel – 5ml Carton

Compare to

Systane ZADITOR

active ingredient*

NDC 21130-601-05

Signature

SELECT®

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 0.17 FL OZ (5 mL)

20074700

GI60107

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%)

Warnings

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

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

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

Questions?

{Phone icon} Call: 1-800-459-7043

*This product is not manufactured or distributed by Alcon owner of the trademarks Systane and ZADITOR.

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, water for injection

Stop Use and Ask A Doctor If (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

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 – 5ml Carton (Package/Label Principal Display Panel – 5mL carton)

Compare to

Systane ZADITOR

active ingredient*

NDC 21130-601-05

Signature

SELECT®

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 0.17 FL OZ (5 mL)

20074700

GI60107

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 (equivalent to ketotifen fumarate 0.035%)", "Warnings": "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 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", "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", "Questions?": "{Phone icon} Call: 1-800-459-7043 *This product is not manufactured or distributed by Alcon owner of the trademarks Systane and ZADITOR.", "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, water for injection", "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", "Keep out of reach of children.": "If swallowed, get medical help or contact a Poison Control Center right away.", "Package/Label Principal Display Panel – 5mL carton": "Compare to Systane ZADITOR active ingredient* NDC 21130-601-05 Signature SELECT® 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 0.17 FL OZ (5 mL) 20074700 GI60107"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:04.918969 · Updated: 2026-03-14T23:02:57.214195