ITCHY EYE- ketotifen fumarate solution/ drops 
Meijer Distribution Inc


Drug Facts

Active ingredient

Ketotifen (0.025%)

(equivalent to ketotifen fumarate 0.035%)




Temporarily relieves itchy eyes due to pollen, ragweed, grass, animal hair and dander.


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

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.


Other information

Inactive ingredients

Benzalkonium Chloride 0.01%, Glycerin, Water for Injection. May contain Hydrochloric Acid and/or Sodium Hydroxide to adjust pH.

Questions or comments?


Serious side effects associated with use of this product may be reported to this number

Principal Display Panel Text for Container Label:

NDC 41250-303-01

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Itchy Eye Drops

Ketotifen Fumarate Ophthalmic Solution 0.035%


Eye Drops

10 mL

0.34 FL OZ


Principal Display Panel Text for Container Label

Principal Display Panel Text for Carton Label:

NDC 41250-303-01 Compare to Alaway®

active ingredient*

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UP TO 12


Itchy Eye Drops

Ketotifen Fumarate Ophthalmic Solution 0.035%

Antihistamine Eye Drops

Works in Minutes

Original Prescription Strength

For ages 3 years and older

60-day supply

10 mL 0.34 FL OZ STERILE

Principal Display Panel Text for Carton Label
ketotifen fumarate solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41250-303
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)  
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41250-303-011 in 1 CARTON01/26/2016
110 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Labeler - Meijer Distribution Inc (006959555)
Registrant - Akorn Operating Company LLC (117693100)
NameAddressID/FEIBusiness Operations
Akorn117696840MANUFACTURE(41250-303) , ANALYSIS(41250-303) , STERILIZE(41250-303) , PACK(41250-303) , LABEL(41250-303)
NameAddressID/FEIBusiness Operations
Akorn AG482198285MANUFACTURE(41250-303)
NameAddressID/FEIBusiness Operations
Akorn117696873LABEL(41250-303) , PACK(41250-303)

Revised: 2/2022
Document Id: 095bec2c-97d8-45a3-be5f-e3601c017a6f
Set id: 11c16152-6feb-45c9-99e3-af514caa2681
Version: 5
Effective Time: 20220211
Meijer Distribution Inc