{"id":"polysorbate-80","rwe":[],"_fda":{"id":"2978d571-17d3-2c20-e063-6394a90a14cd","set_id":"20b934af-fe24-44a2-b313-5540a209432c","openfda":{"unii":["MZ1131787D","6OZP39ZG8H"],"route":["OPHTHALMIC"],"rxcui":["1535485"],"spl_id":["2978d571-17d3-2c20-e063-6394a90a14cd"],"brand_name":["Rohto Cool Max"],"spl_set_id":["20b934af-fe24-44a2-b313-5540a209432c"],"package_ndc":["10742-8159-1"],"product_ndc":["10742-8159"],"generic_name":["NAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80"],"product_type":["HUMAN OTC DRUG"],"substance_name":["NAPHAZOLINE HYDROCHLORIDE","POLYSORBATE 80"],"manufacturer_name":["The Mentholatum Company"],"application_number":["M018"],"is_original_packager":[true]},"purpose":["Purpose Naphazoline hydrochloride - Redness reliever Polysorbate 80 - Lubricant"],"version":"9","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"],"warnings":["Warnings For external use only Ask a doctor before use if you have narrow angle glaucoma When using this product do not touch top 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 remove contact lenses before using 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."],"questions":["Questions? Toll free 1-877-636-2677 MON-FRI 9 AM to 5 PM (EST)"],"ask_doctor":["Ask a doctor before use if you have narrow angle glaucoma"],"effective_time":"20241217","active_ingredient":["Active ingredients Naphazoline hydrochloride 0.03% Polysorbate 80 0.2%"],"inactive_ingredient":["Inactive ingredients alcohol (0.1%), benzalkonium chloride, boric acid, chlorobutanol, edetate disodium, menthol, potassium aspartate, purified water, sodium borate"],"indications_and_usage":["Uses relieves redness of the eye due to minor eye irritations temporarily relieves burning and irritation due to dryness of the eye for protection against further irritation"],"warnings_and_cautions":["When using this product do not touch top 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 remove contact lenses before using"],"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 do not store above 25°C (77°F)"],"spl_product_data_elements":["Rohto Cool Max Naphazoline hydrochloride, Polysorbate 80 BENZALKONIUM CHLORIDE BORIC ACID CHLOROBUTANOL EDETATE DISODIUM MENTHOL, UNSPECIFIED FORM POTASSIUM ASPARTATE WATER SODIUM BORATE NAPHAZOLINE HYDROCHLORIDE NAPHAZOLINE POLYSORBATE 80 POLYSORBATE 80 ALCOHOL"],"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."],"package_label_principal_display_panel":["Package/Label Principal Display Panel Rohto Cool Max"]},"tags":[{"label":"Small Molecule","category":"modality"},{"label":"Intravenous","category":"route"},{"label":"Ophthalmic","category":"route"},{"label":"Liquid","category":"form"},{"label":"Solution","category":"form"},{"label":"Solution/ Drops","category":"form"},{"label":"Active","category":"status"},{"label":"Tear film insufficiency","category":"indication"},{"label":"Excipients","category":"pharmacology"},{"label":"Pharmaceutic Aids","category":"pharmacology"},{"label":"Pharmaceutical Vehicles","category":"pharmacology"},{"label":"Surface-Active Agents","category":"pharmacology"}],"phase":"marketed","safety":{"boxedWarnings":[],"safetySignals":[{"date":"","signal":"EYE IRRITATION","source":"FDA FAERS","actionTaken":"215 reports"},{"date":"","signal":"EYE PAIN","source":"FDA FAERS","actionTaken":"214 reports"},{"date":"","signal":"CATARACT","source":"FDA FAERS","actionTaken":"156 reports"},{"date":"","signal":"VISION BLURRED","source":"FDA FAERS","actionTaken":"110 reports"},{"date":"","signal":"DRY EYE","source":"FDA FAERS","actionTaken":"106 reports"},{"date":"","signal":"DRUG INEFFECTIVE","source":"FDA FAERS","actionTaken":"94 reports"},{"date":"","signal":"OCULAR HYPERAEMIA","source":"FDA FAERS","actionTaken":"88 reports"},{"date":"","signal":"PHOTOPHOBIA","source":"FDA FAERS","actionTaken":"59 reports"},{"date":"","signal":"OFF LABEL USE","source":"FDA FAERS","actionTaken":"52 reports"},{"date":"","signal":"VISUAL IMPAIRMENT","source":"FDA FAERS","actionTaken":"51 reports"}],"commonSideEffects":[],"specialPopulations":{"Lactation":"No data are available regarding the presence of moxetumomab pasudotox-tdfk in human milk, the effects on the breastfed child, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mothers clinical need for LUMOXITI and any potential adverse effects on the breastfed child from LUMOXITI or from the underlying maternal condition.","Pregnancy":"Based on its mechanism of action and findings in non-pregnant female animals, LUMOXITI is expected to cause maternal and embryo-fetal toxicity when administered to pregnant woman. There are no available data on LUMOXITI use in pregnant women to inform drug-associated risk of major birth defects and miscarriage. Animal reproduction or developmental toxicity studies have not been conducted with LUMOXITI. Advise pregnant women of the potential risk to fetus.","Geriatric use":"In the combined safety database of HCL patients treated with LUMOXITI, 31% (40/129) of patients treated with LUMOXITI were 65 years of age or older and 8% (10/129) were 75 years of age or older. Exploratory analyses across this population suggest higher incidence of adverse reactions leading to drug discontinuation (23% versus 7%) and renal toxicity (40% versus 20%) for patients 65 years of age or older as compared to those younger than 65 years.","Paediatric use":"Safety and effectiveness have not been established in pediatric patients."}},"trials":[],"aliases":[],"patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=POLYSORBATE 80","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T00:48:38.510378+00:00"},"aiSummary":{"url":"","method":"ai_extraction","source":"AI Strategic Summary","aiModel":"featherless","rawText":"","confidence":0.9,"sourceType":"ai_extraction","retrievedAt":"2026-04-20T00:49:04.236550+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T00:48:44.892398+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=POLYSORBATE 80","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T00:48:45.220068+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:48:35.511479+00:00"},"indications.approved":{"url":"","method":"ai_extraction","source":"FDA Label + AI","aiModel":"featherless","rawText":"","confidence":0.9,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:48:58.573269+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (no boxed warning)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:48:35.511506+00:00"},"safety.safetySignals":{"url":"https://api.fda.gov/drug/event.json","method":"api_direct","source":"FDA FAERS","rawText":"","confidence":1,"sourceType":"fda_faers","retrievedAt":"2026-04-20T00:48:47.324844+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL1697847/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T00:48:46.524978+00:00"},"regulatory.fda_application":{"url":"","method":"deterministic","source":"FDA Label","rawText":"M018","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:48:35.511509+00:00"}},"allNames":"polyethoxylated sorbitan monooleate","offLabel":[],"synonyms":["polysorbate 80","polyethoxylated sorbitan monooleate"],"timeline":[],"aiSummary":"POLYSORBATE 80, a marketed polyethoxylated sorbitan monooleate, is positioned in the redness relief segment of the ophthalmic market. Its key strength lies in its mechanism of action, which reduces the surface tension of tears to promote an even distribution and maintenance of a healthy tear film. The primary risk is the key composition patent expiry in 2028, which could lead to increased competition from generics.","approvals":[{"date":"","orphan":false,"company":"","regulator":"FDA"}],"brandName":"Polyethoxylated Sorbitan Monooleate","ecosystem":[{"indication":"Tear film insufficiency","otherDrugs":[{"name":"ciclosporin","slug":"ciclosporin","company":"Novartis"},{"name":"crospovidone","slug":"crospovidone","company":""},{"name":"lifitegrast","slug":"lifitegrast","company":"Shire Dev Llc"},{"name":"lutein","slug":"lutein","company":""}],"globalPrevalence":null}],"mechanism":{"modality":"Small Molecule","explanation":"","oneSentence":"","technicalDetail":"POLYSORBATE 80 functions as a non-ionic surfactant, reducing the interfacial tension between the aqueous tear film and the air, thereby facilitating the spreading and stability of the tear film."},"commercial":{},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/2227","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=POLYSORBATE%2080","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=POLYSORBATE 80","fields":["publications"],"source":"PubMed/NCBI"}],"_enrichedAt":"2026-03-30T15:26:42.699634","_validation":{"fieldsValidated":2,"lastValidatedAt":"2026-04-20T00:49:04.236661+00:00","fieldsConflicting":2,"overallConfidence":0.8},"biosimilars":[{"form":"SOLUTION","route":"INTRAVENOUS","company":"Innate Pharma, Inc.","brandName":"IV STABILIZER","isOriginal":"","marketingStatus":"BLA"},{"form":"SOLUTION","route":"INTRAVENOUS","company":"AstraZeneca Pharmaceuticals LP","brandName":"IV Solution 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