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Over-the-counter medicine · no prescription needed

Ketotifen

Purpose on the label: Antihistamine

Eye care

Official FDA data, not advice

The label text is quoted exactly as the company filed it with the U.S. Food and Drug Administration (FDA), with a link to the official copy. The list of brands comes from the FDA NDC Directory.

This page is not medical advice. Read the label on your package, and ask a pharmacist or doctor if you are not sure a medicine is right for you, for your child, or with your other medicines.

If someone may have taken too much, call Poison Help: 1‑800‑222‑1222. In an emergency, call 911.

Quick answers

What is Ketotifen used for?
The Drug Facts label of Alaway (Bausch & Lomb Incorporated) lists these uses: for the temporary relief of itchy eyes due to ragweed, pollen, grass, animal hair and dander..
Do I need a prescription for Ketotifen?
No. The products on this page are sold without a prescription (over the counter).
Is a store brand the same as the name brand?
Products listed together below have the same active ingredient, in the same amount and the same form, as registered with the FDA. Inactive ingredients (such as colors, flavors and fillers) and package sizes can differ. Compare the “Active ingredient” box on both packages, and ask a pharmacist if you are not sure.
Has Ketotifen been recalled?
FDA enforcement reports list 1 recall of products on this page; the newest started June 29, 2022. A recall usually concerns specific products or lots, not every brand.

Drug Facts label

Every over-the-counter medicine must carry a “Drug Facts” box in the same order, set by FDA rules. Below is the label of one product for each common strength and form, quoted word for word. Your own package can differ (for example, children’s products have other directions): always follow the label on your package.

Alaway · Bausch & Lomb Incorporated

Ketotifen fumarate 0.25 mg/mL, solution/ drops (ophthalmic)

Active ingredient

Ketotifen 0.025% (equivalent to ketotifen fumerate 0.035%)

Purpose

Antihistamine

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

Keep out of reach of children

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

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

Inactive ingredients

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

Questions?

[Phone icon] Call: 1-800-553-5340

— FDA label of Alaway, Bausch & Lomb Incorporated, effective May 1, 2022. See the official label on DailyMed →

Equate Eye Itch Relief · Wal-Mart Stores, Inc.

Ketotifen fumarate 0.25 mg/mL, solution (ophthalmic)

Active ingredient

Ketotifen 0.025% (equivalent to ketotifen fumarate 0.035%)

Purpose

Antihistamine

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

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

Adults and children 3 years or 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 Other information Store at 4-25°C (39-77°F)

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

— FDA label of Equate Eye Itch Relief, Wal-Mart Stores, Inc., effective March 23, 2021. See the official label on DailyMed →

Eye Itch Relief · Cardinal Health 110, LLC. DBA Leader

Ketotifen fumarate 0.35 mg/mL, solution/ drops (ophthalmic)

Active ingredient

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

Purpose

Antihistamine

Uses

Temporarily relieves itchy eyes due to pollen, ragweed, grass, animal hair and dander.

Warnings

Do not use

  • if solution changes color or becomes cloudy
  • if you are sensitive to any ingredient in this product
  • to treat contact lens related irritation

When using this product

  • do not touch the tip of container to any surface to avoid contamination
  • remove contact lenses before use
  • wait at least 10 minutes before reinserting contact lens after use
  • 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 eye
  • itching worsens or lasts more than 72 hours

Keep out of reach of children

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

Directions

  • Adults and children 3 years of age and older: Put 1 drop in the affected eye(s) twice daily, every 8 to 12 hours, no more than twice per day.
  • Children under 3 years of age: Consult a doctor

Other information

  • only for use in the eye.
  • store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Inactive ingredients

Benzalkonium Chloride 0.01%, Glycerin, Water for Injection. May contain Hydrochloric Acid and/or Sodium Hydroxide to adjust pH.

Questions?

1-800-932-5676

— FDA label of Eye Itch Relief, Cardinal Health 110, LLC. DBA Leader, effective September 12, 2025. See the official label on DailyMed →

Eye Itch Relief · Walgreen Company

Ketotifen fumarate 0.35 mg/mL, solution (ophthalmic)

Active ingredient

Ketotifen 0.025% (equivalent to ketotifen fumarate 0.035%)

Purpose

Antihistamine

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 content 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

Keep out of reach of children

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

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

Inactive ingredients

benzalkonium chloride 0.01%, glycerin, hydrochloric acid and/or sodium hydroxide, water for injection Questions or comments? {phone icon} Call: 1-800-459-6906

Questions?

{phone icon} Call: 1-800-459-6906

— FDA label of Eye Itch Relief, Walgreen Company, effective March 25, 2026. See the official label on DailyMed →

This page is not medical advice. Read the label on your package, and ask a pharmacist or doctor if you are not sure a medicine is right for you, for your child, or with your other medicines.

Same medicine, other brands

Each group lists the products that have exactly the same active ingredient, in the same amount and form, as registered with the FDA (NDC Directory). A store brand in the same group has the same medicine as the name brand; inactive ingredients, flavors and package sizes can differ. Each product links to its own official label.

Ketotifen fumarate 0.25 mg/mL · solution/ drops (ophthalmic) · 11 products

Drug Facts for this strength and form ↑

Brand or product nameCompany on the labelLabel
Alaway Bausch & Lomb Incorporated DailyMed
Eye Itch Relief A-S Medication Solutions DailyMed
Eye Itch Relief CVS Pharmacy DailyMed
Eye Itch Relief Kroger Company DailyMed
Eye Itch Relief Perrigo Direct Inc. DailyMed
Eye Itch Relief Topco Associates LLC DailyMed
Ketotifen Fumarate A-S Medication Solutions DailyMed
Ketotifen Fumarate Rugby Laboratories DailyMed
Ketotifen Fumarate Ophthalmic Solution Armas Pharmaceuticals Inc. DailyMed
Ketotifen Fumarate Ophthalmic Solution Preferred Pharmaceuticals Inc. DailyMed
Ketotifen Fumarate Ophthalmic Solution Sentiss Pharmaceuticals LLC DailyMed
Ketotifen fumarate 0.25 mg/mL · solution (ophthalmic) · 8 products

Drug Facts for this strength and form ↑

Brand or product nameCompany on the labelLabel
Equate Eye Itch Relief Wal-Mart Stores, Inc. DailyMed
Eye Itch Relief Cardinal Health DailyMed
Eye Itch Relief Redpharm Drug DailyMed
Eye Itch Relief Safeway DailyMed
Eye Itch Relief Target Corporation DailyMed
Ketotifen Fumarate Preferred Pharmaceuticals Inc. DailyMed
Ketotifen Fumarate Unichem Pharmaceuticals (USA), Inc. —
Zaditor Alcon Laboratories, Inc. DailyMed
Ketotifen fumarate 0.35 mg/mL · solution/ drops (ophthalmic) · 2 products

Drug Facts for this strength and form ↑

Brand or product nameCompany on the labelLabel
Eye Itch Relief Cardinal Health 110, LLC. DBA Leader DailyMed
Ketotifen Fumarate Proficient Rx LP DailyMed
Ketotifen fumarate 0.35 mg/mL · solution (ophthalmic) · 1 product

Drug Facts for this strength and form ↑

Brand or product nameCompany on the labelLabel
Eye Itch Relief Walgreen Company DailyMed

What pharmacies pay (NADAC)

The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.

This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.

NADAC per unit for Ketotifen, by strength and form
Strength and formGeneric or brandPharmacies pay
ketotifen fumarate 0.25 mg/mL
solution
Generic $1.29 per mL
ketotifen fumarate 0.25 mg/mL
solution
Brand: Zaditor $1.87–$2.23 per mL
2 packages, lowest to highest
ketotifen fumarate 0.25 mg/mL
solution/ drops
Generic $1.29 per mL

NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.

Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →

Companies that sell this medicine

The company named on the package (maker or distributor), as listed in the FDA NDC Directory, with its number of over-the-counter products of this medicine.

Recalls

From FDA enforcement reports, matched by the product’s NDC code or label. A recall usually covers specific products or lots: check the name and lot number on your package.

  1. June 29, 2022 · Class II · Terminated · D-1317-2022

    CGMP Deviations: products were stored outside the drug label specifications.

    Systane Zaditor, ketotifen fumarate ophthalmic solution 0.035%, Antihistamine eye drops, Eye Itch Relief, up to 12 Hours, Sterile, 30 day supply, 5mL (0.17 FL OZ) bottle per box, Alcon, NDC 0065-4011-05. — Mckesson Medical-Surgical Inc. Corporate Office

Sources

  1. Drug labeling (SPL, openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  2. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  3. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
  4. FDA rule for the Drug Facts label (21 CFR 201.66)

Only medicines marketed under FDA rules for nonprescription drugs (an FDA monograph or an FDA approval) are listed. Homeopathic products are not listed: the FDA does not evaluate them for safety or effectiveness.

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