EYE ITCH RELIEF- ketotifen fumarate solution/ drops 
Rite Aid Corporation

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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. (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?

1-800-932-5676

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

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ORIGINAL

PRESCRIPTION STRENGTH

eye itch relief

ketotifen fumarate

ophthalmic solution 0.035%

antihistamine eye drops

5 mL (0.17 FL OZ) Sterile

Principal Display Panel Text for Container Label

Principal Display Panel Text for Carton Label:

Rite Aid Pharmacy Logo®

*Compare to the active

ingredient of Zaditor®

ORIGINAL PRESCRIPTION STRENGTH

eye itch

relief

ketotifen fumarate

ophthalmic solution 0.035%

antihistamine eye drops

UP TO 12 HOURS

ITCH RELIEF

works in minutes

for ages 3 years and older

30-day supply

Sterile

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:11822-4201
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:11822-4201-01 in 1 CARTON12/06/2013
15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07795812/06/2013
Labeler - Rite Aid Corporation (014578892)
Registrant - Akorn Operating Company LLC (117693100)
Establishment
NameAddressID/FEIBusiness Operations
Akorn117696840MANUFACTURE(11822-4201) , ANALYSIS(11822-4201) , STERILIZE(11822-4201) , PACK(11822-4201) , LABEL(11822-4201)
Establishment
NameAddressID/FEIBusiness Operations
Akorn AG482198285MANUFACTURE(11822-4201)
Establishment
NameAddressID/FEIBusiness Operations
Akorn117696873LABEL(11822-4201) , PACK(11822-4201)

Revised: 2/2022
Document Id: 18fecc27-fa6a-4dbc-9902-f6664b4fd313
Set id: 7410b0e1-ee10-4ca6-9f36-d84a33619880
Version: 5
Effective Time: 20220211
 
Rite Aid Corporation