{
  "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": "2026-06-02",
    "results": {
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  "results": [
    {
      "spl_product_data_elements": [
        "Visine Red Eye Total Comfort and Tears Dry Eye Relief Tetrahydrozoline HCl, Polyethylene Glycol 400, Zinc Sulfate Visine Red Eye Total Comfort Multi-Symptom TETRAHYDROZOLINE HYDROCHLORIDE, POLYETHYLENE GLYCOL 400, and ZINC SULFATE, UNSPECIFIED FORM TETRAHYDROZOLINE HYDROCHLORIDE TETRAHYDROZOLINE BORIC ACID SODIUM CITRATE EDETATE DISODIUM HYPROMELLOSES ZINC SULFATE, UNSPECIFIED FORM ZINC CATION WATER GLYCERIN POLYETHYLENE GLYCOL 400 POLYETHYLENE GLYCOL 400 SODIUM CHLORIDE BENZALKONIUM CHLORIDE Visine Dry Eye Relief Polyethylene Glycol 400 GLYCINE BENZALKONIUM CHLORIDE DEXTROSE SODIUM CHLORIDE SODIUM PHOSPHATE, DIBASIC, ANHYDROUS POTASSIUM CHLORIDE GLYCERIN WATER BORIC ACID MAGNESIUM CHLORIDE SODIUM LACTATE ASCORBIC ACID SODIUM CITRATE POLYETHYLENE GLYCOL 400 POLYETHYLENE GLYCOL 400 HYPROMELLOSES SODIUM BORATE"
      ],
      "spl_unclassified_section": [
        "VISINE ® Red Eye Total Comfort Multi-Symptom Drug Facts",
        "VISINE ® Dry Eye Relief Drug Facts",
        "Distributed by: JOHNSON & JOHNSON CONSUMER INC. Skillman, NJ 08558"
      ],
      "active_ingredient": [
        "Active ingredient Polyethylene glycol 400 1% Tetrahydrozoline HCl 0.05% Zinc sulfate 0.25%",
        "Active ingredient Polyethylene glycol 400 1%"
      ],
      "purpose": [
        "Purpose Lubricant Redness reliever Astringent",
        "Purpose Lubricant"
      ],
      "indications_and_usage": [
        "Uses for the temporary relief of discomfort and redness of the eye due to minor eye irritations relieves dryness of the eye for the temporary relief of burning and irritation due to exposure to wind or sun for protection against further irritation",
        "Uses for the temporary relief of burning and irritation due to dryness of the eye for protection against further irritation"
      ],
      "warnings": [
        "Warnings For external use only Ask a doctor before use if you have narrow angle glaucoma. When using this product • some users may experience a brief tingling sensation • pupils may become enlarged temporarily • overuse may cause more eye redness • remove contact lenses before using • do not use if this solution changes color or becomes cloudy • do not touch tip of container to any surface to avoid contamination • replace cap after each use Stop use and ask a doctor if • you feel eye pain • changes in vision occur • redness or irritation of the eye lasts • condition worsens or lasts 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 right away.",
        "Warnings For external use only When using this product • remove contact lenses before using • do not use if this solution changes color or becomes cloudy • do not touch tip of container to any surface to avoid contamination • replace cap after each use Stop use and ask a doctor if • you feel eye pain • changes in vision occur • redness or irritation of the eye lasts • condition worsens or lasts 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 right away."
      ],
      "ask_doctor": [
        "Ask a doctor before use if you have narrow angle glaucoma."
      ],
      "when_using": [
        "When using this product • some users may experience a brief tingling sensation • pupils may become enlarged temporarily • overuse may cause more eye redness • remove contact lenses before using • do not use if this solution changes color or becomes cloudy • do not touch tip of container to any surface to avoid contamination • replace cap after each use",
        "When using this product • remove contact lenses before using • do not use if this solution changes color or becomes cloudy • do not touch tip of container to any surface to avoid contamination • replace cap after each use"
      ],
      "stop_use": [
        "Stop use and ask a doctor if • you feel eye pain • changes in vision occur • redness or irritation of the eye lasts • condition worsens or lasts more than 72 hours",
        "Stop use and ask a doctor if • you feel eye pain • changes in vision occur • redness or irritation of the eye lasts • condition worsens or lasts more than 72 hours"
      ],
      "pregnancy_or_breast_feeding": [
        "If pregnant or breast-feeding, ask a health professional before use.",
        "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.",
        "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away."
      ],
      "dosage_and_administration": [
        "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",
        "Directions • adults and children 6 years of age and over: put 1 or 2 drops in the affected eye(s) as needed • children under 6 years of age: consult a doctor"
      ],
      "storage_and_handling": [
        "Other information Store at 20° to 25°C (68° to 77°F)",
        "Other information Store at room temperature"
      ],
      "inactive_ingredient": [
        "Inactive ingredients benzalkonium chloride, boric acid, edetate disodium, glycerin, hypromellose, purified water, sodium chloride, sodium citrate",
        "Inactive ingredients ascorbic acid, benzalkonium chloride, boric acid, dextrose, disodium phosphate, glycerin, glycine, hypromellose, magnesium chloride, potassium chloride, purified water, sodium borate, sodium chloride, sodium citrate, sodium lactate"
      ],
      "questions": [
        "Questions? call toll-free 888-734-7648 or 215-273-8755 (collect)",
        "Questions? call toll-free 888-734-7648 or 215-273-8755 (collect)"
      ],
      "package_label_principal_display_panel": [
        "PRINCIPAL DISPLAY PANEL - Kit Package VALUE MULTI-PACK VISINE ® RED EYE TOTAL COMFORT MULTI-SYMPTOM ASTRINGENT / LUBRICANT / REDNESS RELIEVER EYE DROPS UP TO 10 HRS COMFORT ALL-IN ONE RELIEF From Red, Burning, Watery, Itchy, Dry, Gritty, Irritated Eyes Protects Against Further Irritation STERILE Use products only as directed. DRY EYE RELIEF LUBRICANT EYE DROPS MOISTURIZES + SOOTHES DRY, GRITTY EYES Designed to Work Like Real Tears 1 BOTTLE: VISINE® RED EYE TOTAL COMFORT MULTI-SYMPTOM ½ FL OZ (15 mL) 1 BOTTLE: VISINE® DRY EYE RELIEF ½ FL OZ (15 mL) Visine_01"
      ],
      "set_id": "0bc0d6e7-9195-db6b-e063-6294a90aef04",
      "id": "21d23d1a-0ebb-3cb3-e063-6294a90abeb7",
      "effective_time": "20241114",
      "version": "2",
      "openfda": {
        "application_number": [
          "M018"
        ],
        "brand_name": [
          "Visine Red Eye Total Comfort and Tears Dry Eye Relief"
        ],
        "generic_name": [
          "TETRAHYDROZOLINE HCL, POLYETHYLENE GLYCOL 400, ZINC SULFATE"
        ],
        "manufacturer_name": [
          "Kenvue Brands LLC"
        ],
        "product_ndc": [
          "69968-0844"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "rxcui": [
          "2360899",
          "2360903"
        ],
        "spl_id": [
          "21d23d1a-0ebb-3cb3-e063-6294a90abeb7"
        ],
        "spl_set_id": [
          "0bc0d6e7-9195-db6b-e063-6294a90aef04"
        ],
        "package_ndc": [
          "69968-0844-9",
          "69968-0360-1",
          "69968-0363-1"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0312547493987"
        ]
      }
    }
  ]
}