drug facts
5196ec5b-42d9-40db-a77a-c00360b8cee6
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Purpose
Antihistamine
Description
Ketotifen (0.025%) (equivalent to ketotifen fumarate 0.035%)
Medication Information
Warnings
For external use only
Purpose
Antihistamine
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.
Description
Ketotifen (0.025%) (equivalent to ketotifen fumarate 0.035%)
Questions?
Call Product Information at 973-315-1818. Serious side effects associated with use of this product may be reported to this number.
Code No.: GO/DRUGS/557
Manufactured For:
Bayshore Pharmaceuticals
LLC., Short Hills, NJ 07078
Made in India.
Relabeled By: Preferred Pharmaceuticals Inc.
Use
Temporarily relieves itchy eyes due to pollen, ragweed, grass, animal hair and dander.
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
Active Ingredient
Ketotifen (0.025%)
(equivalent to ketotifen fumarate 0.035%)
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.
Principal Display Panel Bottle Carton
NDC 68788-8715-5
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
Structured Label Content
Warnings
For external use only
Purpose
Antihistamine
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 (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 (Inactive ingredients)
benzalkonium chloride 0.01%, glycerol, water for injection, sodium hydroxide and/or hydrochloric acid.
Questions?
Call Product Information at 973-315-1818. Serious side effects associated with use of this product may be reported to this number.
Code No.: GO/DRUGS/557
Manufactured For:
Bayshore Pharmaceuticals
LLC., Short Hills, NJ 07078
Made in India.
Relabeled By: Preferred Pharmaceuticals Inc.
Use
Temporarily relieves itchy eyes due to pollen, ragweed, grass, animal hair and dander.
Do Not Use (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
Active Ingredient (Active ingredient)
Ketotifen (0.025%)
(equivalent to ketotifen fumarate 0.035%)
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.
Principal Display Panel Bottle Carton (Principal Display Panel - Bottle Carton)
NDC 68788-8715-5
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
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
Back to search View SPL set listing Open on DailyMed ↗
Source: dailymed · Ingested: 2026-02-15T12:06:30.586338 · Updated: 2026-03-14T23:09:18.179019