SPL UNCLASSIFIED SECTION
Drug Facts
Active ingredient
Ketotifen (0.025%)
(equivalent to ketotifen fumarate 0.035%)
Purpose
Antihistamine
Uses
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 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° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Inactive ingredients
Benzalkonium Chloride 0.01%, Glycerin, Purified Water. May contain Hydrochloric Acid and/or Sodium Hydroxide to adjust pH.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Principal Display Panel Text for Container Label:
H ■ E ■ B Logo®
NDC 37808-802-01
Eye Itch
Relief
Ketotifen Fumarate
Ophthalmic Solution
Antihistamine Eye Drops
STERILE 5 mL (0.17 FL OZ)
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Principal Display Panel Text for Carton Label:
NDC 37808-802-01 Compare to
the active
ingredients
in Zaditor®*
H ■ E ■ B Logo®
Eye Itch
Relief
Ketotifen Fumarate
Ophthalmic Solution
Antihistamine Eye Drops
Eye Drops
• Works in
Minutes
• Original
Prescription
Strength
• For ages
3 years
& Older
UP TO
12
HOURS
ITCH RELIEF
STERILE 5 mL (0.17 FL OZ)