KETOTIFEN FUMARATE- ketotifen fumarate solution/ drops 
Walgreens

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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

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 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

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?

1-800-932-5676

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Eye Itch Relief

KETOTIFEN FUMARATE
OPHTHALMIC SOLUTION /
ANTIHISTAMINE EYE DROPS

● Sterile

0.34 FL OZ (10 mL)

Principal Display Panel Text for Container Label:

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Compare to Alaway® active ingredient††

Eye Itch

Relief

KETOTIFEN FUMARATE
OPHTHALMIC SOLUTION /
ANTIHISTAMINE EYE DROPS

WORKS IN MINUTES

0.34 FL OZ (10 mL)

Principal Display Panel Text for Carton Label
KETOTIFEN FUMARATE 
ketotifen fumarate solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-9060
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ketotifen fumarate (UNII: HBD503WORO) (Ketotifen - UNII:X49220T18G) Ketotifen0.25 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:0363-9060-001 in 1 CARTON01/25/2013
110 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07795801/25/2013
Labeler - Walgreens (008965063)
Registrant - Akorn Operating Company LLC (117693100)
Establishment
NameAddressID/FEIBusiness Operations
Akorn117696840MANUFACTURE(0363-9060) , ANALYSIS(0363-9060) , STERILIZE(0363-9060) , PACK(0363-9060) , LABEL(0363-9060)
Establishment
NameAddressID/FEIBusiness Operations
Akorn AG482198285MANUFACTURE(0363-9060)
Establishment
NameAddressID/FEIBusiness Operations
Akorn117696873LABEL(0363-9060) , PACK(0363-9060)

Revised: 2/2022
Document Id: 904a9117-866f-4edc-9a6a-aa86b7a23a26
Set id: 1a59d294-5eb4-43e9-b48e-42c4fbd05498
Version: 9
Effective Time: 20220211
 
Walgreens