Amerisource Bergen Eye Itch Relief Drug Facts

Amerisource Bergen Eye Itch Relief Drug Facts
SPL v7
SPL
SPL Set ID e110e5fc-f853-4711-8134-515c7577775d
Route
OPHTHALMIC
Published
Effective Date 2013-07-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Ketotifen (0.25 mg)
Inactive Ingredients
Glycerin Water Hydrochloric Acid Sodium Hydroxide

Identifiers & Packaging

Marketing Status
ANDA Active Since 2010-11-13
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%)

Use

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

Directions

. Adults and children 3 years of age 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.

Do Not Use

. If solution changes color or becomes cloudyi

. If you are sensitive to any ingredient in this product

. To treat contact lens related irritation

Active Ingredient

Ketotifen (0.025%)

(equivalent to ketotifen fumarate 0.035%)

Other Information

. Only for use in the eye

. Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature]

Inactive Ingredients

benzalkonium chloride 0.01%, glycerin, purified water. May contain hydrochloric acid and/or sodium hydroxide (to adjust pH).

Questions Or Comments?

1-800-719-9260

When Using This Product

. Do not touch tip of container to any surface to avoid contamination

. Remove contact lenses before use

. Wait at least 10 minutes before reinserting contact lenses 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 for more than 72 hours

Keep Out of Reach of Children.

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

Package Label Principal Display Panel

NDC 68258-8900-05

Structured Label Content

Use

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

Purpose

Antihistamine

Directions

. Adults and children 3 years of age 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.

Do Not Use (Do not use)

. If solution changes color or becomes cloudyi

. If you are sensitive to any ingredient in this product

. To treat contact lens related irritation

Active Ingredient (Active ingredient)

Ketotifen (0.025%)

(equivalent to ketotifen fumarate 0.035%)

Other Information (Other information)

. Only for use in the eye

. Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature]

Inactive Ingredients (Inactive ingredients)

benzalkonium chloride 0.01%, glycerin, purified water. May contain hydrochloric acid and/or sodium hydroxide (to adjust pH).

Questions Or Comments? (Questions or comments?)

1-800-719-9260

When Using This Product (When using this product)

. Do not touch tip of container to any surface to avoid contamination

. Remove contact lenses before use

. Wait at least 10 minutes before reinserting contact lenses after use

. Replace cap after each use

Stop Use and Ask A Doctor If (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 for more than 72 hours

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. (1-800-222-1222)

Package Label Principal Display Panel (PACKAGE LABEL PRINCIPAL DISPLAY PANEL)

NDC 68258-8900-05

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:55:40.100086 · Updated: 2026-03-14T22:53:32.846368