SPL UNCLASSIFIED SECTION
Drug Facts
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
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
OTC - STOP USE SECTION
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
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
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 8-12 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° 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).
Questions?
call toll-free 1-800-932-5676, weekdays, 7:00 AM - 5:30 PM CST
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Principal Display Panel Text for Carton Label:
Now OTC! NDC 17478-060-12
Akorn Logo
Ketotifen
Fumarate
Ophthalmic
Solution
ANTIHISTAMINE EYE DROPS
UP TO 12 HOURS EYE ITCH RELIEF
Works in Minutes
Original Prescription Strength
FOR AGES 3 YEARS AND OLDER
30 DAY SUPPLY
5 mL (0.17 FL OZ) Sterile