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

Purpose

Antihistamine

Description

Ketotifen 0.025% (equivalent to ketotifen fumarate 0.035%)

Medication Information

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

Uses

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

Purpose

Antihistamine

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% (equivalent to ketotifen fumarate 0.035%)

Active Ingredient

Ketotifen 0.025%

(equivalent to ketotifen fumarate 0.035%)

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

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

Uses

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

Purpose

Antihistamine

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

Active Ingredient (Active ingredient)

Ketotifen 0.025%

(equivalent to ketotifen fumarate 0.035%)

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