KETOTIFEN FUMARATE- ketotifen fumarate solution/ drops 
KAISER FOUNDATION HOSPITALS

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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

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

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 Water for Injection. May contain Hydrochloric Acid and/or Sodium Hydroxide (to adjust pH).

Questions?

call toll-free 1-800-932-5676, weekdays, 7:00 AM -5:30 PM CST

Principal Display Panel Text for Container Label:

NDC 0179-8601-05

KAISER PERMANENTE® Logo

Ketotifen Fumarate

Ophthalmic Solution

Antihistamine Eye Drop

5 mL (0.17 FL OZ) Sterile

Principal Display Panel Text for Container Label

Principal Display Panel Text for Carton Label:

NDC 0179-8601-05

KAISER PERMANENTE® Logo

Ketotifen

Fumarate

Ophthalmic Solution

Antihistamine

Eye drop

Up to 12 hours of

eye itch relief

0.025% Sterile solution

*Compare to Zaditor®

5 mL (0.17 FL OZ)

Principal Display Panel Text for Carton Label
KETOTIFEN FUMARATE 
ketotifen fumarate solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0179-8601
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ketotifen fumarate (UNII: HBD503WORO) (Ketotifen - UNII:X49220T18G) Ketotifen0.35 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
benzalkonium chloride (UNII: F5UM2KM3W7)  
glycerin (UNII: PDC6A3C0OX)  
water (UNII: 059QF0KO0R)  
hydrochloric acid (UNII: QTT17582CB)  
sodium hydroxide (UNII: 55X04QC32I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0179-8601-051 in 1 CARTON11/08/201109/30/2021
15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07795811/08/201109/30/2021
Labeler - KAISER FOUNDATION HOSPITALS (053052619)
Registrant - Akorn Operating Company LLC (117693100)

Revised: 10/2020
Document Id: 75063907-4489-4b77-bd38-415a0820a58b
Set id: 14a5dbbb-71ed-4c14-818f-accc2efe0020
Version: 4
Effective Time: 20201008
 
KAISER FOUNDATION HOSPITALS