{
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    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-04-03",
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      "spl_product_data_elements": [
        "KETOTIFEN FUMARATE KETOTIFEN FUMARATE KETOTIFEN FUMARATE KETOTIFEN GLYCERIN SODIUM HYDROXIDE HYDROCHLORIC ACID BENZALKONIUM CHLORIDE"
      ],
      "spl_unclassified_section": [
        "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. 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°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. Inactive ingredients benzalkonium chloride 0.01%, glycerol, water for injection, sodium hydroxide and/or hydrochloric acid. Questions? Call Product Information at 1-866-562-4616. Serious side effects associated with use of this product may be reported to this number. Made in India Distributed by: UNICHEM PHARMACEUTICALS (USA), INC. East Brunswick, NJ 08816 USA Rev. 11/2025 KFO1236"
      ],
      "active_ingredient": [
        ""
      ],
      "purpose": [
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      "keep_out_of_reach_of_children": [
        ""
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        ""
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      "warnings": [
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      "package_label_principal_display_panel": [
        "PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 76385-106-17 Ketotifen Fumarate Opthalmic Solution 0.035% ANTIHISTAMINE EYE DROPS 5 mL (0.17 FL OZ) Sterile ketotifenfumaratelabel",
        "PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 76385-106-17 Now OTC Ketotifen Fumarate Opthalmic Solution 0.035% ANTIHISTAMINE EYE DROPS UP TO 12 HOURS Eye Itch Relief Works in Minutes Original Prescription Strength for ages 3 years and older 20 day supply 5 mL (0.17 FL OZ) Sterile ketotifenfumaratecarton"
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      "id": "948d4259-9d62-4bc7-9149-6961034364bf",
      "effective_time": "20251124",
      "version": "2",
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        "application_number": [
          "ANDA204059"
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        "brand_name": [
          "KETOTIFEN FUMARATE"
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        "generic_name": [
          "KETOTIFEN FUMARATE"
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        "manufacturer_name": [
          "Unichem Pharmaceuticals (USA), Inc."
        ],
        "product_ndc": [
          "76385-106"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "OPHTHALMIC"
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        "substance_name": [
          "KETOTIFEN FUMARATE"
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        "rxcui": [
          "311237"
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        "package_ndc": [
          "76385-106-17"
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        "is_original_packager": [
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        "unii": [
          "HBD503WORO"
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