{
  "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": "2026-06-03",
    "results": {
      "skip": 0,
      "limit": 1,
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  },
  "results": [
    {
      "spl_product_data_elements": [
        "Visine Red Eye Hydrating Comfort, CVP tetrahydrozoline hydrochloride and polyethylene glycol 400 solution/ drops TETRAHYDROZOLINE HYDROCHLORIDE TETRAHYDROZOLINE BORIC ACID HYPROMELLOSE, UNSPECIFIED SODIUM CITRATE, UNSPECIFIED FORM POTASSIUM CHLORIDE WATER SODIUM PHOSPHATE, DIBASIC, ANHYDROUS ASCORBIC ACID MAGNESIUM CHLORIDE SODIUM LACTATE POLIXETONIUM CHLORIDE DEXTROSE, UNSPECIFIED FORM GLYCERIN POLYETHYLENE GLYCOL 400 POLYETHYLENE GLYCOL 400 GLYCINE"
      ],
      "spl_unclassified_section": [
        "Drug Facts",
        "Other information Other information Store at 20° to 25°C (68° to 77°F)"
      ],
      "active_ingredient": [
        "Active ingredients ​Active ingredients Polyethylene glycol 400 1% Tetrahydrozoline HCl 0.05% Purpose ​Purpose Lubricant Redness reliever"
      ],
      "purpose": [
        "Purpose ​Purpose Lubricant Redness reliever"
      ],
      "indications_and_usage": [
        "Uses ​Uses for the relief of redness of the eye due to minor eye irritations for the temporary relief of burning, irritation, and discomfort due to dryness of the eye or exposure to wind or sun for use as a protectant against further irritation or to relieve dryness of the eye"
      ],
      "warnings": [
        "Warnings For external use only. Ask a doctor before use Ask a doctor before use if you have narrow angle glaucoma. When using this product When using this product pupils may become enlarged temporarily overuse may cause more eye redness remove contact lenses before using replace cap after each use do not use if this solution changes color or becomes cloudy do not touch tip of container to any surface to avoid contamination Stop use and ask a doctor if Stop use and ask a doctor if you feel eye pain redness or irritation of the eye lasts changes in vision occur condition worsens or lasts more than 72 hours If pregnant 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 right away."
      ],
      "ask_doctor": [
        "Ask a doctor before use Ask a doctor before use if you have narrow angle glaucoma."
      ],
      "when_using": [
        "When using this product When using this product pupils may become enlarged temporarily overuse may cause more eye redness remove contact lenses before using replace cap after each use do not use if this solution changes color or becomes cloudy do not touch tip of container to any surface to avoid contamination"
      ],
      "stop_use": [
        "Stop use and ask a doctor if Stop use and ask a doctor if you feel eye pain redness or irritation of the eye lasts changes in vision occur condition worsens or lasts more than 72 hours"
      ],
      "pregnancy_or_breast_feeding": [
        "If pregnant 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. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away."
      ],
      "dosage_and_administration": [
        "Directions Directions adults and children 6 years of age and over: put 1 or 2 drops in the affected eye(s) up to 4 times a day children under 6 years of age: consult a doctor children under 2 years of age: do not use"
      ],
      "inactive_ingredient": [
        "Inactive ingredients Inactive ingredients ascorbic acid, boric acid, dextrose, glycerin, glycine, hypromellose, magnesium chloride, polyquaternium-42, potassium chloride, purified water, sodium citrate, sodium lactate, sodium phosphate dibasic"
      ],
      "questions": [
        "Questions? Questions? call toll-free 888-734-7648 or 215-273-8755 (collect)"
      ],
      "package_label_principal_display_panel": [
        "Visine ® Red Eye Hydrating Comfort, CVP ® Health [CVP ® Health logo] VISINE ® RED EYE HYDRATING COMFORT LUBRICAN/REDNESS RELIEVER EYE DROPS WORKS IN 30 SECONDS Redness + Irritation Relief Lubricates & Refreshes STERILE 0.8 FL OZ (8mL) PDP/Package"
      ],
      "set_id": "0f50bcc8-3658-8c2c-e063-6294a90a8e13",
      "id": "0f50bcc8-3659-8c2c-e063-6294a90a8e13",
      "effective_time": "20240119",
      "version": "1",
      "openfda": {
        "application_number": [
          "M018"
        ],
        "brand_name": [
          "Visine Red Eye Hydrating Comfort, CVP"
        ],
        "generic_name": [
          "TETRAHYDROZOLINE HYDROCHLORIDE AND POLYETHYLENE GLYCOL 400 SOLUTION/ DROPS"
        ],
        "manufacturer_name": [
          "Lil' Drug Store Products, Inc."
        ],
        "product_ndc": [
          "66715-6584"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "OPHTHALMIC"
        ],
        "substance_name": [
          "POLYETHYLENE GLYCOL 400",
          "TETRAHYDROZOLINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "996209"
        ],
        "spl_id": [
          "0f50bcc8-3659-8c2c-e063-6294a90a8e13"
        ],
        "spl_set_id": [
          "0f50bcc8-3658-8c2c-e063-6294a90a8e13"
        ],
        "package_ndc": [
          "66715-6584-8"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "B697894SGQ",
          "0YZT43HS7D"
        ]
      }
    }
  ]
}