RxRegimen check replace synthesize
Back to Library
FDA LABEL GENERIC: Ketotifen MFR: Unichem Pharmaceuticals (USA), Inc.

Ketotifen 0.025 % (as Ketotifen Fumarate 0.035 % ) Ophthalmic Solution

Active ingredient

Ketotifen (0.025%)

(equivalent to ketotifen fumarate 0.035%)

Purpose

Antihistamine

Use

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

Warnings

For external use only

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 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.

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°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. Inactive ingredients

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

Questions?

Call Product Information at 1-866-562-4616. Serious side effects associated with use of this product may be reported to this number.

Made in India

Distributed by:

UNICHEM PHARMACEUTICALS (USA), INC.

East Brunswick, NJ 08816 USA

Rev. 11/2025

KFO1236

INDICATIONS AND USAGE

WARNINGS

DOSAGE AND ADMINISTRATION

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 76385-106-17

Ketotifen Fumarate Opthalmic Solution 0.035%

ANTIHISTAMINE EYE DROPS

5 mL (0.17 FL OZ)

Sterile

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 76385-106-17

Now OTC

Ketotifen Fumarate Opthalmic Solution 0.035%

ANTIHISTAMINE EYE DROPS

UP TO 12 HOURS

Eye Itch Relief

Works in Minutes

Original Prescription Strength

for ages 3 years and older

20 day supply

 5 mL (0.17 FL OZ)

 Sterile