EYE ITCH RELIEF- ketotifen fumarate solution/ drops 
STRATEGIC SOURCING SERVICES LLC

----------

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. (1-800-222-1222)

Directions

Other information

Inactive ingredients

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

Telephone
Questions or comments?

1-800-932-5676

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

Principal Display Panel Text for Container Label:

Health Mart®

NDC 62011-0232-1

Eye Itch Relief

Ketotifen Fumarate

Ophthalmic Solution 0.035%

Antihistamine Eye Drops

Sterile

5 mL (0.17 FL OZ)

Principal Display Panel Text for Container Label

Principal Display Panel Text for Carton Label:

NDC 62011-0232-1

Health Mart®

Compare to Zaditor® Active Ingredient*

For Ages 3 Years and Older

Eye Itch Relief

Ketotifen Fumarate

Ophthalmic Solution 0.035%

Antihistamine Eye Drops

Original Prescription Strength

Works in Minutes

Sterile

Up to 12 Hours

30-Day Supply

5 mL (0.17 FL OZ)

Principal Display Panel Text for Carton Label
EYE ITCH RELIEF 
ketotifen fumarate solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62011-0232
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:62011-0232-11 in 1 CARTON02/07/2014
15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07795802/07/2014
Labeler - STRATEGIC SOURCING SERVICES LLC (116956644)
Registrant - Akorn Operating Company LLC (117693100)
Establishment
NameAddressID/FEIBusiness Operations
Akorn117696840MANUFACTURE(62011-0232) , ANALYSIS(62011-0232) , STERILIZE(62011-0232) , PACK(62011-0232) , LABEL(62011-0232)
Establishment
NameAddressID/FEIBusiness Operations
Akorn AG482198285MANUFACTURE(62011-0232)
Establishment
NameAddressID/FEIBusiness Operations
Akorn117696873LABEL(62011-0232) , PACK(62011-0232)

Revised: 2/2022
Document Id: 15206723-e08f-429b-a36f-90b73d82af4f
Set id: 38a248d6-3029-49c9-9198-efc883f2e67f
Version: 6
Effective Time: 20220210
 
STRATEGIC SOURCING SERVICES LLC