{"id":"propylene-glycol-0-3","_fda":{"id":"90134f50-ea64-4651-a2c0-afa48e09f129","set_id":"df13ca6f-7ce1-455a-ae13-9bbc5e9d2e07","openfda":{"rxcui":["477589","895753","1989901"],"spl_id":["90134f50-ea64-4651-a2c0-afa48e09f129"],"brand_name":["Systane Day and Night Value Pack"],"spl_set_id":["df13ca6f-7ce1-455a-ae13-9bbc5e9d2e07"],"package_ndc":["0065-1502-10"],"product_ndc":["0065-1502"],"generic_name":["POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL 0.3%"],"product_type":["HUMAN OTC DRUG"],"manufacturer_name":["Alcon Laboratories, Inc."],"application_number":["M018"],"is_original_packager":[true]},"purpose":["Active ingredients Purpose Polyethylene Glycol 400 0.4% Lubricant Propylene Glycol 0.3% Lubricant","Active ingredients Purpose Polyethylene Glycol 400 0.4% Lubricant Propylene Glycol 0.3% Lubricant"],"version":"9","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","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"],"warnings":["Warnings For external use only","Warnings For external use only"],"questions":["Questions? In the U.S. call 1-800-757-9195 alcon.medinfo@alcon.com www.systane.com","Questions? In the U.S. call toll free 1-800-757-9195 alcon.medinfo@alcon.com www.systane.com"],"do_not_use":["Do not use if this product changes color or becomes cloudy if you are sensitive to any ingredient in this product","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 replace cap after each use","When using this product do not touch tip of container to any surface to avoid contamination replace cap after each use"],"purpose_table":["<table border=\"0\" cellpadding=\"4\" cellspacing=\"0\" width=\"40%\"><tbody><tr><td styleCode=\"Toprule\"><content styleCode=\"italics\"><content styleCode=\"bold\">Active ingredients</content></content></td><td align=\"right\" styleCode=\"Toprule\"><content styleCode=\"italics\"><content styleCode=\"bold\">Purpose</content></content></td></tr><tr><td>Polyethylene Glycol 400 0.4%</td><td align=\"right\">Lubricant</td></tr><tr><td styleCode=\"Botrule\">Propylene Glycol 0.3%</td><td align=\"right\" styleCode=\"Botrule\">Lubricant</td></tr></tbody></table>","<table border=\"0\" cellpadding=\"4\" cellspacing=\"0\" width=\"40%\"><tbody><tr><td styleCode=\"Toprule\"><content styleCode=\"italics\"><content styleCode=\"bold\">Active ingredients</content></content></td><td align=\"right\" styleCode=\"Toprule\"><content styleCode=\"italics\"><content styleCode=\"bold\">Purpose</content></content></td></tr><tr><td>Polyethylene Glycol 400 0.4%</td><td align=\"right\">Lubricant</td></tr><tr><td styleCode=\"Botrule\">Propylene Glycol 0.3%</td><td align=\"right\" styleCode=\"Botrule\">Lubricant</td></tr></tbody></table>"],"effective_time":"20231215","active_ingredient":["SYSTANE ® ULTRA Lubricant Eye Drops Active ingredients Purpose Polyethylene Glycol 400 0.4% Lubricant Propylene Glycol 0.3% Lubricant","SYSTANE ® GEL DROPS Lubricant Eye Gel Active ingredients Purpose Polyethylene Glycol 400 0.4% Lubricant Propylene Glycol 0.3% Lubricant"],"inactive_ingredient":["Inactive ingredients aminomethylpropanol, boric acid, hydroxypropyl guar, POLYQUAD ® (polyquaternium-1) 0.001% preservative, potassium chloride, purified water, sodium chloride, sorbitol. May contain hydrochloric acid and/or sodium hydroxide to adjust pH.","Inactive ingredients aminomethylpropanol, boric acid, edetate disodium, hydroxypropyl guar, POLYQUAD ® (polyquaternium-1) 0.001% preservative, potassium chloride, sodium chloride, sorbitol and purified water. May contain hydrochloric acid and/or sodium hydroxide to adjust pH."],"storage_and_handling":["Other information store at room temperature","Other information store at room temperature"],"indications_and_usage":["Uses temporary relief of burning and irritation due to dryness of the eye temporarily relieves discomfort due to minor irritations of the eye or to exposure to wind or sun","Uses temporary relief of burning and irritation due to dryness of the eye temporarily relieves discomfort due to minor irritations of the eye or to exposure to wind or sun"],"active_ingredient_table":["<table border=\"0\" cellpadding=\"4\" cellspacing=\"0\" width=\"40%\"><tbody><tr><td styleCode=\"Toprule\"><content styleCode=\"italics\"><content styleCode=\"bold\">Active ingredients</content></content></td><td align=\"right\" styleCode=\"Toprule\"><content styleCode=\"italics\"><content styleCode=\"bold\">Purpose</content></content></td></tr><tr><td>Polyethylene Glycol 400 0.4%</td><td align=\"right\">Lubricant</td></tr><tr><td styleCode=\"Botrule\">Propylene Glycol 0.3%</td><td align=\"right\" styleCode=\"Botrule\">Lubricant</td></tr></tbody></table>","<table border=\"0\" cellpadding=\"4\" cellspacing=\"0\" width=\"40%\"><tbody><tr><td styleCode=\"Toprule\"><content styleCode=\"italics\"><content styleCode=\"bold\">Active ingredients</content></content></td><td align=\"right\" styleCode=\"Toprule\"><content styleCode=\"italics\"><content styleCode=\"bold\">Purpose</content></content></td></tr><tr><td>Polyethylene Glycol 400 0.4%</td><td align=\"right\">Lubricant</td></tr><tr><td styleCode=\"Botrule\">Propylene Glycol 0.3%</td><td align=\"right\" styleCode=\"Botrule\">Lubricant</td></tr></tbody></table>"],"dosage_and_administration":["Directions shake well before using put 1 or 2 drops in the affected eye(s) as needed","Directions shake well before using put 1 or 2 drops in the affected eye(s) as needed"],"spl_product_data_elements":["Systane Day and Night Value Pack Polyethylene Glycol 400, Propylene Glycol 0.3% SYSTANE ULTRA Lubricant Eye Drops Polyethylene Glycol 400, Propylene Glycol Polyethylene Glycol 400 Polyethylene Glycol 400 Propylene Glycol Propylene Glycol Aminomethylpropanol Boric Acid Guar Gum Polidronium Chloride Potassium Chloride Water Sodium Chloride Hydrochloric Acid Sodium Hydroxide SYSTANE DROPS Polyethylene Glycol 400, Propylene Glycol Polyethylene Glycol 400 Polyethylene Glycol 400 Propylene Glycol Propylene Glycol Aminomethylpropanol Boric Acid Edetate Disodium Guar Gum Polidronium Chloride Potassium Chloride Sodium Chloride Sorbitol Water Hydrochloric Acid Sodium Hydroxide Carton Ultra DayNight bottle label Bottle Label"],"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."],"package_label_principal_display_panel":["PACKAGE LABEL.PRINCIPAL DISPLAY PANEL DAY & NIGHT VALUE PACK Systane ® ULTRA LUBRICANT EYE DROPS HIGH PERFORMING DRY EYE RELIEF DAYTIME Fast-acting hydration and lasting relief Moisture-rich formula #1 DOCTOR RECOMMENDED BRAND 1 GEL DROPS LUBRICANT EYE GEL SOOTHING DRY EYE RELIEF NIGHTTIME Long-lasting formula Day or night protection LIQUID GEL STERILE Two 10 mL Bottles (1/3 FL OZ EACH) Alcon ® This Value Pack gives you fast-acting hydration and long-lasting relief, for day or night protection. ACTUAL SIZE BOTTLES TAMPER EVIDENT: For your protection, each bottle has an imprinted seal around the neck. Do not use if seal is damaged or missing at time of purchase. www.alconpatents.com ALCON LABORATORIES, INC. Fort Worth, TX 76134 USA Made in USA from domestic and foreign materials 300048647-0621 LOT: EXP.: Systane ® ULTRA LUBRICANT EYE DROPS HIGH PERFORMANCE STERILE 10 mL (1/3 FL OZ) FOR EXTERNAL USE ONLY. INDICATIONS: For the temporary relief of burning and irritation due to dryness of the eye. DIRECTIONS: Shake well and instill 1 or 2 drops in the affected eye(s) as needed. WARNINGS: See carton for WARNINGS. INGREDIENTS: Actives: Polyethylene Glycol 400 0.4%, Propylene Glycol 0.3%. Inactives: Aminomethylpropanol, boric acid, hydroxypropyl guar, POLYQUAD® (polyquaternium-1) 0.001% preservative, potassium chloride, purified water, sodium chloride, sorbitol. May contain hydrochloric acid and/or sodium hydroxide to adjust pH. Store at room temperature. Alcon Laboratories, Inc. Fort Worth, TX 76134 USA Alcon ® LOT: EXP.: 300055616-1221 Systane ® GEL DROPS LUBRICANT EYE GEL Soothing Dry Eye Relief STERILE 10 mL (1/3 FL OZ) FOR EXTERNAL USE ONLY. Uses: See carton for USES. WARNINGS: See carton for WARNINGS. Directions: Shake well and put 1 or 2 drops in the affected eye(s) as needed. INGREDIENTS: Actives: Polyethylene Glycol 0.4% and Propylene Glycol 0.3%. Inactives: Aminomethylpropanol, boric acid, edetate disodium, hydroxypropyl guar, POLYQUAD® (polyquaternium-1) 0.001% preservative, potassium chloride, sodium chloride, sorbitol and purified water. May contain hydrochloric acid and/or sodium hydroxide to adjust pH. Store at room temperature. Alcon Laboratories, Inc. Fort Worth, TX 76134 USA Alcon LOT: EXP.: 300048641-0621"]},"safety":{"boxedWarnings":[]},"_chembl":{"chemblId":"CHEMBL286398","moleculeType":"Small molecule","molecularWeight":"76.10"},"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=Propylene Glycol 0.3%","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T04:32:51.762067+00:00"},"aiSummary":{"url":"","method":"ai_extraction","source":"AI Strategic Summary","aiModel":"featherless","rawText":"","confidence":0.9,"sourceType":"ai_extraction","retrievedAt":"2026-04-20T04:33:16.687284+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T04:32:57.103574+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=Propylene Glycol 0.3%","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T04:32:57.392402+00:00"},"indications.approved":{"url":"","method":"ai_extraction","source":"FDA Label + AI","aiModel":"featherless","rawText":"","confidence":0.9,"sourceType":"fda_label","retrievedAt":"2026-04-20T04:33:11.838575+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (no boxed warning)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T04:32:50.644188+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL286398/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T04:32:58.164139+00:00"},"regulatory.fda_application":{"url":"","method":"deterministic","source":"FDA Label","rawText":"M018","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T04:32:50.644238+00:00"}},"_dailymed":{"setId":"df13ca6f-7ce1-455a-ae13-9bbc5e9d2e07","title":"SYSTANE DAY AND NIGHT VALUE PACK (POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL 0.3%) KIT [ALCON LABORATORIES, INC.]"},"aiSummary":"Propylene Glycol 0.3%, marketed by Innovative Medical, is positioned in the eye irritation relief segment. 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