Drug Facts

Drug Facts

SPL v3

SPL

SPL Set ID e5fd1246-c4a7-4be3-a3d3-83d82ec6cab8

Route

OPHTHALMIC

Published

Effective Date 2023-12-08

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 2020-08-07

Description

Ketotifen 0.025% (equivalent to ketotifen fumarate 0.035%)

Purpose

Antihistamine

Medication Information

Purpose

Antihistamine

Description

Ketotifen 0.025% (equivalent to ketotifen fumarate 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

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

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

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 fumarate 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: 1-877-758-1480

Keep Out of Reach of Children.

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

Package/label Principal Display Panel

LEADER[heart icon]™

NDC 70000-0522-2

Sterile / Eye Drops

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

COMPARE to

Systane ZADITOR

active ingredient*

100% Money

Back Guarantee

0.34 FL OZ (10 mL) 9688902

F860109

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

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

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

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 fumarate 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: 1-877-758-1480

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)

LEADER[heart icon]™

NDC 70000-0522-2

Sterile / Eye Drops

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

COMPARE to

Systane ZADITOR

active ingredient*

100% Money

Back Guarantee

0.34 FL OZ (10 mL) 9688902

F860109

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.", "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 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 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", "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 fumarate 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: 1-877-758-1480", "Keep out of reach of children.": "If swallowed, get medical help or contact a Poison Control Center right away.", "Package/Label Principal Display Panel": "LEADER[heart icon]™ NDC 70000-0522-2 Sterile / Eye Drops 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 COMPARE to Systane ZADITOR active ingredient* 100% Money Back Guarantee 0.34 FL OZ (10 mL) 9688902 F860109"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:31.230565 · Updated: 2026-03-14T23:02:06.847821