EYE ITCH RELIEF- ketotifen fumarate solution/ drops 
Rugby Laboratories

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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 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?

1-800-645-2158

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

Principal Display Panel Text for Container Label:

Rugby® Logo

NDC 0536-1096-40

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:

Rugby® Logo NDC 0536-1096-40

Compare to the active

ingredient in Zaditor®*

Eye Itch

Relief

Ketotifen Fumarate

Ophthalmic Solution 0.035%

ANTIHISTAMINE EYE DROPS

UP TO

12

HOURS

ITCH RELIEF

For ages 3 years and older

30-day supply

5 mL (0.17 FL OZ) STERILE

Principal Display Panel Text for Carton Label
EYE ITCH RELIEF 
ketotifen fumarate solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1096
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:0536-1096-401 in 1 CARTON01/20/2016
15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07795801/20/2016
Labeler - Rugby Laboratories (079246066)
Registrant - Akorn Operating Company LLC (117693100)
Establishment
NameAddressID/FEIBusiness Operations
Akorn117696840MANUFACTURE(0536-1096) , ANALYSIS(0536-1096) , STERILIZE(0536-1096) , PACK(0536-1096) , LABEL(0536-1096)
Establishment
NameAddressID/FEIBusiness Operations
Akorn AG482198285MANUFACTURE(0536-1096)
Establishment
NameAddressID/FEIBusiness Operations
Akorn117696873LABEL(0536-1096) , PACK(0536-1096)

Revised: 2/2022
Document Id: 188df731-6f6a-4a79-9464-97d52efd213c
Set id: 82a31fcf-b36d-4111-b2bf-6a51a8b6c5da
Version: 6
Effective Time: 20220211
 
Rugby Laboratories