Drug Facts

Drug Facts

SPL v3

SPL

SPL Set ID 7d0146a9-5073-4e24-954f-75b84affadc2

Route

OPHTHALMIC

Published

Effective Date 2020-12-15

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 2020-04-01

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 ifyou 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.

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] Toll Free Product Information

Call: 1-866-767-9161

Keep Out of Reach of Children.

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

Package/label Principal Display Panel

[heart icon] CVS

Health

NDC 69842-275-10

Eye Itch

Relief

ketotifen fumarate

ophthalmic solution 0.035%

ANTIHISTAMINE EYE DROPS

Works in minutes
Original prescription strength
For ages 3 years & older
60-day supply

UP TO

12

HOURS

EYE ITCH

RELIEF

Package Contains

One Bottle

STERILE

0.034 FL OZ (10 mL)

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 ifyou 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.

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] Toll Free Product Information

Call: 1-866-767-9161

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)

[heart icon] CVS

Health

NDC 69842-275-10

Eye Itch

Relief

ketotifen fumarate

ophthalmic solution 0.035%

ANTIHISTAMINE EYE DROPS

Works in minutes
Original prescription strength
For ages 3 years & older
60-day supply

UP TO

12

HOURS

EYE ITCH

RELIEF

Package Contains

One Bottle

STERILE

0.034 FL OZ (10 mL)

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 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. 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] Toll Free Product Information Call: 1-866-767-9161", "Keep out of reach of children.": "If swallowed, get medical help or contact a Poison Control Center right away.", "Package/Label Principal Display Panel": "[heart icon] CVS Health NDC 69842-275-10 Eye Itch Relief ketotifen fumarate ophthalmic solution 0.035% ANTIHISTAMINE EYE DROPS Works in minutes Original prescription strength For ages 3 years & older 60-day supply UP TO 12 HOURS EYE ITCH RELIEF Package Contains One Bottle STERILE 0.034 FL OZ (10 mL)"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:08:14.723853 · Updated: 2026-03-14T23:12:25.780176