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

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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 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.

Questions or comments?

1-800-923-5676

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

Principal Display Panel Text for Container Label:

Sunmark Logo®

NDC 49348-107-17

sterile

eye itch relief

ketotifen fumarate

ophthalmic solution 0.035%

Antihistamine Eye Drops

5 mL (0.17 FL OZ)

Principal Display Panel Text for Container Label

Principal Display Panel Text for Carton Label:

Sunmark Logo®

COMPARE TO ZADITOR®

ACTIVE INGREDIENT*

NDC 49348-107-17

sterile

eye itch

relief

ketotifen fumarate

ophthalmic

solution 0.035%

Antihistamine Eye Drops

For ages 3 years and older

30-day supply

Works in minutes

Original Prescription Strength

UP TO 12 HOURS OF RELIEF

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:49348-107
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:49348-107-171 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(49348-107) , ANALYSIS(49348-107) , STERILIZE(49348-107) , PACK(49348-107) , LABEL(49348-107)
Establishment
NameAddressID/FEIBusiness Operations
Akorn AG482198285MANUFACTURE(49348-107)
Establishment
NameAddressID/FEIBusiness Operations
Akorn117696873LABEL(49348-107) , PACK(49348-107)

Revised: 2/2022
Document Id: 24adab31-1a43-43bc-ae11-4c00bc122c31
Set id: 1ff86d21-cf4b-4a53-9d73-be331160c37a
Version: 7
Effective Time: 20220210
 
STRATEGIC SOURCING SERVICES LLC