{ "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, "total": 2 } }, "results": [ { "spl_product_data_elements": [ "Systane polyethylene glycol and propylene glycol Polyethylene Glycol 400 Polyethylene Glycol, Unspecified PROPYLENE GLYCOL PROPYLENE GLYCOL BORIC ACID CALCIUM CHLORIDE GUAR GUM MAGNESIUM CHLORIDE POTASSIUM CHLORIDE WATER SODIUM CHLORIDE ZINC CHLORIDE HYDROCHLORIC ACID SODIUM HYDROXIDE Front Label Back Label" ], "active_ingredient": [ "Active Ingredients" ], "purpose": [ "Active Ingredients Purpose Polyethylene Glycol 400 0.4% Lubricant Propylene Glycol 0.3% Lubricant" ], "purpose_table": [ "
Active IngredientsPurpose
Polyethylene Glycol 400 0.4%Lubricant
Propylene Glycol 0.3%Lubricant
" ], "indications_and_usage": [ "Uses For the temporary relief of burning and irritation due to dryness of the eye" ], "warnings": [ "Warnings For external use only Do not use if this product changes color or becomes cloudy if you are sensitive to any ingredient in this product When using this product do not touch tip of container to any surface to avoid contamination do not reuse once opened, discard Stop use and ask a doctor if you experience any of the following: eye pain changes in vision continued redness or irritation of the eye condition worsens or persists for more than 72 hours Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "do_not_use": [ "Do not use if this product changes color or becomes cloudy if you are sensitive to any ingredient in this product" ], "when_using": [ "When using this product do not touch tip of container to any surface to avoid contamination do not reuse once opened, discard" ], "stop_use": [ "Stop use and ask a doctor if you experience any of the following: eye pain changes in vision continued redness or irritation of the eye condition worsens or persists for 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 instill 1 or 2 drops in the affected eye(s) as needed" ], "spl_unclassified_section": [ "Other Information store at room temperature protect from light" ], "inactive_ingredient": [ "Inactive Ingredients boric acid, calcium chloride, hydroxypropyl guar, magnesium chloride, potassium chloride, purified water, sodium chloride, zinc chloride. May contain hydrochloric acid and/or sodium hydroxide to adjust pH." ], "questions": [ "Questions? In the U.S. call 1-800-757-9195 alcon.medinfo@alcon.com www.systane.com" ], "package_label_principal_display_panel": [ "Principal Display Panel Systane ® LUBRICANT EYE DROPS ORIGINAL PF PRESERVATIVE-FREE DRY EYE RELIEF Convenient Single Vials On-the-Go Great for Sensitive Eyes Refreshes & Lubricates Soothing Comfort #1 Doctor Recommended Brand 1 STERILE 30 Vials 0.7 mL Each Alcon Side Panel (s) SOOTHING COMFORT SYSTANE ® Original PF Lubricant Eye Drops is scientifically formulated to shield eyes from dry eye discomfort so that eyes feel refreshed. LONG-LASTING RELIEF SYSTANE ® Original PF Lubricant Eye Drops provides long-lasting dry eye relief. PRESERVATIVE-FREE SYSTANE ® Original PF Lubricant Eye Drops comes in convenient preservative-free vials so you can enjoy relief from dry eye anytime, anywhere. TAMPER EVIDENT: Do not use if vial is damaged or opened at time of purchase. 1 Based on a survey of eye care professionals. Data on file. www.alconpatents.com Made in France 435241-0819 Systane ® LUBRICANT EYE DROPS ORIGINAL PF PRESERVATIVE-FREE DRY EYE RELIEF DIRECTIONS: Make sure container is intact before use. To open, COMPLETELY TWIST OFF TAB. Do not pull off. Put 1 or 2 drops in the affected eye(s) as needed. Throw away container. Do not reuse. Manufactured for: ALCON Alcon Laboratories, Inc. Fort Worth, TX 76134 USA" ], "set_id": "14916d2c-a63d-491e-bd91-a61f300af38a", "id": "5c7432b0-b4b8-49a1-89b7-6e3befa25917", "effective_time": "20231215", "version": "11", "openfda": { "application_number": [ "M018" ], "brand_name": [ "Systane" ], "generic_name": [ "POLYETHYLENE GLYCOL AND PROPYLENE GLYCOL" ], "manufacturer_name": [ "Alcon Research Ltd" ], "product_ndc": [ "0065-0431" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "OPHTHALMIC" ], "substance_name": [ "POLYETHYLENE GLYCOL 400", "PROPYLENE GLYCOL" ], "rxcui": [ "477589" ], "spl_id": [ "5c7432b0-b4b8-49a1-89b7-6e3befa25917" ], "spl_set_id": [ "14916d2c-a63d-491e-bd91-a61f300af38a" ], "package_ndc": [ "0065-0431-04", "0065-0431-32", "0065-0431-57", "0065-0431-33" ], "is_original_packager": [ true ], "unii": [ "B697894SGQ", "6DC9Q167V3" ] } } ] }