{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-10-30",
    "results": {
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  "results": [
    {
      "spl_product_data_elements": [
        "CareOne Itchy Relief Eye Drops 15mL Tetrahydrozoline HCI, Zinc sulfate ZINC SULFATE ZINC CATION TETRAHYDROZOLINE HYDROCHLORIDE TETRAHYDROZOLINE BENZALKONIUM CHLORIDE EDETATE DISODIUM EDETIC ACID SODIUM CITRATE SODIUM CHLORIDE BORIC ACID WATER"
      ],
      "active_ingredient": [
        "Active ingredients Tetrahydrozoline HCI 0.05% Zinc sulfate 0.25%"
      ],
      "purpose": [
        "Purposes Redness reliever Astringent"
      ],
      "indications_and_usage": [
        "Uses for temporary relief of discomfort and redness of the eye due to minor eye irritations"
      ],
      "warnings": [
        "Warnings For external use only Ask a doctor before use if you have narrow angle glaucoma When using this product pupils may become enlarged temporarily to avoid contamination, do not touch tip of container to any surface. Replace cap after using. if solution changes color or becomes cloudy, do not use overuse may produce increased redness of the eye remove contact lenses before using Stop use and ask a doctor if you experience eye pain changes in vision continued redness or irritation of the eye, or if the condition worsens or persists for more than 72 hours If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away."
      ],
      "ask_doctor": [
        "Ask a doctor before use if you have narrow angle glaucoma"
      ],
      "when_using": [
        "When using this product pupils may become enlarged temporarily to avoid contamination, do not touch tip of container to any surface. Replace cap after using. if solution changes color or becomes cloudy, do not use overuse may produce increased redness of the eye remove contact lenses before using"
      ],
      "stop_use": [
        "Stop use and ask a doctor if you experience eye pain changes in vision continued redness or irritation of the eye, or if the condition worsens or persists for more than 72 hours"
      ],
      "pregnancy_or_breast_feeding": [
        "If pregnant or breast-feeding, ask a health professional before use."
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away."
      ],
      "dosage_and_administration": [
        "Directions instill 1 to 2 drops in the affected eye(s) up to 4 times daily"
      ],
      "other_safety_information": [
        "Other information store at 15°-30°C (59°-86°F)"
      ],
      "inactive_ingredient": [
        "Inactive ingredients benzalkonium chloride, boric acid, edetate disodium, purified water, sodium chloride, sodium citrate"
      ],
      "package_label_principal_display_panel": [
        "Careone Itchy Relief Eye Drops 15mL Careone Itchy Relief Eye Drops 15mL"
      ],
      "set_id": "997f16ff-2632-2e9d-e053-2995a90a6f51",
      "id": "4749275b-6984-4eaf-e063-6394a90aaee9",
      "effective_time": "20251230",
      "version": "3",
      "openfda": {
        "application_number": [
          "M018"
        ],
        "brand_name": [
          "CareOne Itchy Relief Eye Drops 15mL"
        ],
        "generic_name": [
          "TETRAHYDROZOLINE HCI, ZINC SULFATE"
        ],
        "manufacturer_name": [
          "Retail Business Services, LLC."
        ],
        "product_ndc": [
          "72476-011"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "OPHTHALMIC"
        ],
        "substance_name": [
          "ZINC SULFATE",
          "TETRAHYDROZOLINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "1043249"
        ],
        "spl_id": [
          "4749275b-6984-4eaf-e063-6394a90aaee9"
        ],
        "spl_set_id": [
          "997f16ff-2632-2e9d-e053-2995a90a6f51"
        ],
        "package_ndc": [
          "72476-011-01"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0041520865335"
        ],
        "unii": [
          "89DS0H96TB",
          "0YZT43HS7D"
        ]
      }
    }
  ]
}