Official product label reference

Eye Itch Relief — CVS Pharmacy

This page contains 9 source sections for KETOTIFEN FUMARATE, ophthalmic route. Label set 7d0146a9-5073-4e24-954f-75b84affadc2, version 4.

Retrieved 2026-10-02 · openFDA dataset updated 2026-10-02 · Check the current DailyMed label

Label records can cover multiple strengths or package sizes. A label listing does not by itself establish FDA approval or current market availability. Check the source and application history for this specific product.

Uses described in the label

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

Purpose

Purpose Antihistamine

Dosage and administration — label text

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, wait at least 5 minutes between each product Children under 3 years of age: consult a doctor

Warnings

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

Active ingredient

Active ingredient Ketotifen 0.025% (equivalent to ketotifen fumarate 0.035%)

Child safety

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Unclassified section

Other information Store at 4-25°C (39-77°F)

Inactive ingredient

Inactive ingredients benzalkonium chloride 0.01%, glycerin, hydrochloric acid and/or sodium hydroxide, water for injection

Questions

Questions or comments? [phone icon] Call: 1-866-767-9161

Official sources and product identifiers

DailyMed — complete source labelVerify the current version and original formatting, including tables and diagrams.
openFDA — structured source recordMachine-readable label source, linked by the exact label set ID.
Drugs@FDA application NDA021996Application history where available; verify the specific product and indication.

Substances listed: KETOTIFEN FUMARATE

RxNorm identifiers: 311237

Package NDC codes

69842-275-10, 69842-275-05, 69842-275-20

Further research and background

These are external searches for related information. Research, encyclopedia and news articles have not been imported into this product record.

Coverage and corrections

The text is extracted from a US structured product label. Tables are represented as text where supplied; formatting and illustrations may be lost. A missing section does not mean a risk is absent. This reference has not been independently reviewed by a clinician and is not a live safety-alert service.

Source retrieved 2026-10-02. Read the source policy.

Eye Itch Relief drug information