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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

For external use only


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. (1-800-222-1222)


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, Water for Injection. May contain hydrochloric acid and/or sodium hydroxide (to adjust pH).


PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display Panel Text for Container Label:

Rite Aid Pharmacy Logo®

ORIGINAL

PRESCRIPTION STRENGTH

eye itch relief

ketotifen fumarate

ophthalmic solution 0.035%

antihistamine eye drops

5 mL (0.17 FL OZ) Sterile


PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display Panel Text for Carton Label:

Rite Aid Pharmacy Logo®

*Compare to the active

ingredient of Zaditor®

ORIGINAL PRESCRIPTION STRENGTH

eye itch

relief

ketotifen fumarate

ophthalmic solution 0.035%

antihistamine eye drops

UP TO 12 HOURS

ITCH RELIEF

works in minutes

for ages 3 years and older

30-day supply

Sterile

5 mL

(0.17 FL OZ)