KETOTIFEN FUMARATE- ketotifen fumarate solution/ drops 
Akorn

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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

Other information

Inactive ingredients

Benzalkonium Chloride 0.01%; Glycerin and Purified Water. May contain Hydrochloric Add 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 17478-717-10

Ketotifen Fumarate

Ophthalmic Solution

ANTIHISTAMINE EYE DROPS

5 mL (0.17 FL OZ) Sterile

Principal Display Panel Text for Container Label

Principal Display Panel Text for Carton Label:

Now OTC! NDC 17478-060-12

Akorn Logo

Ketotifen

Fumarate

Ophthalmic

Solution

ANTIHISTAMINE EYE DROPS

UP TO 12 HOURS EYE ITCH RELIEF

Works in Minutes

Original Prescription Strength

FOR AGES 3 YEARS AND OLDER

30 DAY SUPPLY

5 mL (0.17 FL OZ) Sterile

Principal Display Panel Text for Carton Label
KETOTIFEN FUMARATE 
ketotifen fumarate solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17478-717
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:17478-717-101 in 1 CARTON10/01/2007
15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2NDC:17478-717-111 in 1 CARTON09/30/201605/18/2022
210 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07795810/01/2007
Labeler - Akorn (117693100)
Establishment
NameAddressID/FEIBusiness Operations
Akorn AG482198285MANUFACTURE(17478-717) , ANALYSIS(17478-717) , PACK(17478-717) , LABEL(17478-717)
Establishment
NameAddressID/FEIBusiness Operations
Akorn117696840MANUFACTURE(17478-717) , ANALYSIS(17478-717) , LABEL(17478-717) , PACK(17478-717) , STERILIZE(17478-717)

Revised: 9/2022
Document Id: 730d47be-f8fa-45a4-829d-e8b43c850c44
Set id: 1376a697-bcf3-47a4-ba0d-8be7aa395c56
Version: 9
Effective Time: 20220912
 
Akorn