1376a697-bcf3-47a4-ba0d-8be7aa395c56
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Drug Facts
Purpose
Antihistamine
Medication Information
Purpose
Antihistamine
Description
Drug Facts
Use
Temporarily relieves itchy eyes due to pollen, ragweed, grass, animal hair and dander.
Section 42229-5
Drug Facts
Section 50565-1
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Section 50566-9
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
Section 51945-4
Principal Display Panel Text for Container Label:
NDC 17478-717-10
Ketotifen Fumarate
Ophthalmic Solution
ANTIHISTAMINE EYE DROPS
5 mL (0.17 FL OZ) Sterile
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 cloudy
- if you are sensitive to any ingredient in this product
- to treat contact lens related irritation
Questions?
call toll-free 1-800-932-5676, weekdays, 7:00 AM - 5:30 PM CST
Active Ingredient
Ketotifen (0.025%)
(equivalent to Ketotifen Fumarate 0.035%)
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 and Purified Water. May contain Hydrochloric Add and/or Sodium Hydroxide (to adjust pH).
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
Structured Label Content
Use
Temporarily relieves itchy eyes due to pollen, ragweed, grass, animal hair and dander.
Section 42229-5 (42229-5)
Drug Facts
Section 50565-1 (50565-1)
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Section 50566-9 (50566-9)
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
Section 51945-4 (51945-4)
Principal Display Panel Text for Container Label:
NDC 17478-717-10
Ketotifen Fumarate
Ophthalmic Solution
ANTIHISTAMINE EYE DROPS
5 mL (0.17 FL OZ) Sterile
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 cloudy
- if you are sensitive to any ingredient in this product
- to treat contact lens related irritation
Questions?
call toll-free 1-800-932-5676, weekdays, 7:00 AM - 5:30 PM CST
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° to 25°C (68° TO 77°F) [see USP Controlled Room Temperature].
Inactive Ingredients (Inactive ingredients)
Benzalkonium Chloride 0.01%; Glycerin and Purified Water. May contain Hydrochloric Add and/or Sodium Hydroxide (to adjust pH).
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
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:00:19.066046 · Updated: 2026-03-14T23:00:41.107943