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

Purpose

Antihistamine (equivalent to ketotifen fumarate 0.035%)

Description

Ketotifen 0.025%

Medication Information

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

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
▪
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

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

Description

Ketotifen 0.025%

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%

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

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

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
▪
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

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?

{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%

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