drug facts
b0eb7b54-4f4e-4ca2-8e4e-30d18d662401
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Purpose
Antihistamine
How Supplied
Product: 50090-7253 NDC: 50090-7253-0 5 mL in a BOTTLE, DROPPER / 1 in a CARTON
Description
Ketotifen 0.025% (equivalent to ketotifen fumerate 0.035%)
Medication Information
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
Uses
for the temporary relief of itchy eyes due to ragweed, pollen, grass, animal hair and dander.
Purpose
Antihistamine
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
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
How Supplied
Product: 50090-7253
NDC: 50090-7253-0 5 mL in a BOTTLE, DROPPER / 1 in a CARTON
Description
Ketotifen 0.025% (equivalent to ketotifen fumerate 0.035%)
Active Ingredient
Ketotifen 0.025%
(equivalent to ketotifen fumerate 0.035%)
Ketotifen Fumarate
Questions Or Comments?
[Phone icon] Call: 1-833-354-4500
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
Keep Out of Reach of Children.
If swallowed, get medical help or contact a Poison Control Center right away.
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
Structured Label Content
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
Uses
for the temporary relief of itchy eyes due to ragweed, pollen, grass, animal hair and dander.
Purpose
Antihistamine
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
Other Information (Other information)
store at 4-25 °C (39-77 °F)
Inactive Ingredients (Inactive ingredients)
benzalkonium chloride 0.01%, glycerin, hydrochloric acid and/or sodium hydroxide, water for injection
How Supplied (HOW SUPPLIED)
Product: 50090-7253
NDC: 50090-7253-0 5 mL in a BOTTLE, DROPPER / 1 in a CARTON
Active Ingredient (Active ingredient)
Ketotifen 0.025%
(equivalent to ketotifen fumerate 0.035%)
Ketotifen Fumarate
Questions Or Comments? (Questions or comments?)
[Phone icon] Call: 1-833-354-4500
When Using This Product (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
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.
Stop Use and Ask A Doctor If You Experience Any of the Following: (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
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
Back to search View SPL set listing Open on DailyMed ↗
Source: dailymed · Ingested: 2026-02-15T12:03:39.309537 · Updated: 2026-03-14T23:03:49.531028