KETOTIFEN FUMARATE SOLUTION/ DROPS [PROFICIENT RX LP]

KETOTIFEN FUMARATE SOLUTION/ DROPS [PROFICIENT RX LP]
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NDC 71205-115-05
Set ID 3a9e70ab-d188-488c-8c47-a2184eb4ef2c
Category HUMAN OTC DRUG LABEL
Packager Proficient Rx LP
Generic Name
Product Class
Product Number
Application Number ANDA077958
  • 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

    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.

  • Directions

    Adults and children 3 years of age and older: Put 1 drop in the affected eye(s) twice daily, every 8-12 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 and Purified Water. May contain Hydrochloric Add and/or Sodium Hydroxide (to adjust pH).

  • Questions?

    call toll-free 1-800-932-5676, weekdays, 7:00 AM - 5:30 PM CST

  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel Text for Carton Label:

    Now OTC! NDC 71205-115-05

    Ketotifen

    Fumarate

    Ophthalmic

    Solution

    ANTIHISTAMINE EYE DROPS

    UP TO 12 HOURS EYE ITCH RELIEF

    Works in Minutes

    Original Prescription Strength

    FOR AGES 3 YEARS AND OLDER

    30 DAY SUPPLY

    5 mL (0.17 FL OZ) Sterile

    71205-115-05
  • INGREDIENTS AND APPEARANCE
    KETOTIFEN FUMARATE 
    ketotifen fumarate solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71205-115(NDC:17478-717)
    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:71205-115-051 in 1 CARTON09/04/2018
    15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07795810/01/2007
    Labeler - Proficient Rx LP (079196022)
    Establishment
    NameAddressID/FEIBusiness Operations
    Proficient Rx LP079196022RELABEL(71205-115)

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