EYE ITCH RELIEF (KETOTIFEN FUMARATE) SOLUTION/ DROPS [RUGBY LABORATORIES]

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EYE ITCH RELIEF (KETOTIFEN FUMARATE) SOLUTION/ DROPS [RUGBY LABORATORIES]
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NDC 0536-1096-40
Set ID 82a31fcf-b36d-4111-b2bf-6a51a8b6c5da
Category HUMAN OTC DRUG LABEL
Packager Rugby Laboratories
Generic Name
Product Class
Product Number
Application Number ANDA077958
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  • SPL UNCLASSIFIED SECTION

    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

    • Adults and children 3 years of age and older:
      Put 1 drop in the affected eye(s) twice daily, every 8 to 12 hours, no more than twice per day.
    • Children under 3 years of age:
      Consult a doctor.
  • Other information

    • only for use in the eye.
    • store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
  • 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

    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

    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

    • 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
  • INGREDIENTS AND APPEARANCE
    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
    Akorn, Inc117696840MANUFACTURE(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
    Hi-Tech Pharmacal Co. Inc.117696873LABEL(0536-1096) , PACK(0536-1096)
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