{
  "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": "2026-08-11",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 2
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Rohto All-In-One Hypromellose, Tetrahydrozoline hydrochloride, Zinc sulfate MENTHOL, UNSPECIFIED FORM POLYSORBATE 80 WATER SODIUM BORATE HYPROMELLOSE, UNSPECIFIED HYPROMELLOSE, UNSPECIFIED TETRAHYDROZOLINE HYDROCHLORIDE TETRAHYDROZOLINE ZINC SULFATE, UNSPECIFIED FORM ZINC CATION EDETATE DISODIUM BORIC ACID"
      ],
      "active_ingredient": [
        "Active ingredients Hypromellose 0.2% Tetrahydrozoline HCl 0.05% Zinc sulfate 0.25%"
      ],
      "purpose": [
        "Purpose Hypromellose - Lubricant Tetrahydrozoline HCl - Redness reliever Zinc sulfate - Astringent"
      ],
      "indications_and_usage": [
        "Uses temporarily relieves redness of the eye and discomfort due to minor eyes irritations exposure to wind or sun temporarily relieves burning and irritation due to dryness of the eye"
      ],
      "warnings": [
        "Warnings For external use only Ask a doctor before use if you have narrow angle glaucoma When using this product do not touch tip of container to any surface to avoid contamination replace cap after each use do not use if solution changes color or becomes cloudy overuse may cause more eye redness pupils may become enlarged temporarily Stop use and ask a doctor if you feel eye pain changes in vision occur redness or irritation of the eyes lasts condition 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."
      ],
      "when_using": [
        "When using this product do not touch tip of container to any surface to avoid contamination replace cap after each use do not use if solution changes color or becomes cloudy overuse may cause more eye redness pupils may become enlarged temporarily"
      ],
      "stop_use": [
        "Stop use and ask a doctor if you feel eye pain changes in vision occur redness or irritation of the eyes lasts condition worsens or lasts more than 72 hours"
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away."
      ],
      "dosage_and_administration": [
        "Directions put 1 or 2 drops in the affected eye(s) up to 4 times daily tightly snap on cap to seal Other information store at 20-25°C (68-77°F)"
      ],
      "inactive_ingredient": [
        "Inactive ingredients boric acid, edetate disodium, menthol, polysorbate 80, purified water, sodium borate"
      ],
      "questions": [
        "Questions? 1-877-636-2677 MON-FRI 9 AM-5 PM (EST)"
      ],
      "package_label_principal_display_panel": [
        "Package Label/Principal Display Panel Image 1"
      ],
      "set_id": "43e690e4-b381-46e3-838c-33aef5bdadde",
      "id": "53610d02-cacc-6819-e063-6294a90ab06e",
      "effective_time": "20260603",
      "version": "5",
      "openfda": {
        "application_number": [
          "M018"
        ],
        "brand_name": [
          "Rohto All-In-One"
        ],
        "generic_name": [
          "HYPROMELLOSE, TETRAHYDROZOLINE HYDROCHLORIDE, ZINC SULFATE"
        ],
        "manufacturer_name": [
          "The Mentholatum Company"
        ],
        "product_ndc": [
          "10742-8146"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "OPHTHALMIC"
        ],
        "substance_name": [
          "HYPROMELLOSE, UNSPECIFIED",
          "TETRAHYDROZOLINE HYDROCHLORIDE",
          "ZINC SULFATE, UNSPECIFIED FORM"
        ],
        "rxcui": [
          "1098640"
        ],
        "spl_id": [
          "53610d02-cacc-6819-e063-6294a90ab06e"
        ],
        "spl_set_id": [
          "43e690e4-b381-46e3-838c-33aef5bdadde"
        ],
        "package_ndc": [
          "10742-8146-1"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0310742010862"
        ],
        "unii": [
          "3NXW29V3WO",
          "0YZT43HS7D",
          "89DS0H96TB"
        ]
      }
    }
  ]
}