{"id":"zinc-acetate","rwe":[],"_fda":{"id":"0d6e3c43-9696-7732-e063-6394a90adc1e","set_id":"027ed5ab-05ec-569f-e063-6394a90abbc3","openfda":{"upc":["0194346121601"],"unii":["88AYB867L5","FM5526K07A"],"route":["TOPICAL"],"rxcui":["1294033"],"spl_id":["0d6e3c43-9696-7732-e063-6394a90adc1e"],"brand_name":["Equate Calaspray"],"spl_set_id":["027ed5ab-05ec-569f-e063-6394a90abbc3"],"package_ndc":["79903-212-03"],"product_ndc":["79903-212"],"generic_name":["PRAMOXINE HCL 1%, ZINC ACETATE 0.1%"],"product_type":["HUMAN OTC DRUG"],"substance_name":["PRAMOXINE HYDROCHLORIDE","ZINC ACETATE"],"manufacturer_name":["Walmart Inc"],"application_number":["M017"],"is_original_packager":[true]},"purpose":["Topical analgesic / Skin protectant"],"version":"2","warnings":["For external use only. Flammable. Keep away from fire or flame. Do not use on deep or puncture wounds, animal bites, or serious burns. When using this product avoid contact with eyes. In case of contact with eyes, flush thoroughly with water. avoid contact with broken skin, do not inhale or ingest, contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120F. Stop use and ask a doctor if condition worsens, rash or irritation develops and lasts for more than 7 days or clears up and occurs again within a few days."],"effective_time":"20231226","active_ingredient":["Pramoxine HCl 1%, Zinc acetate 0.1%"],"inactive_ingredient":["Alcohol denat., camphor, citric acid, ethylhexylglycerin, fragrance, glycerin, hydroxypropyl methylcellulose, phenoxyethanol, polysorbate 40, propylene glycol, sodium citrate, water."],"indications_and_usage":["For the temporary relief of pain and itching associated with rashes due to poison ivy, oak and sumac insect bites minor skin irritations minor cuts dries the oozing and weeping of poison ivy, oak, and sumac"],"dosage_and_administration":["Adults and children 2 years or older: apply to affected are not more than 3 to 4 times daily. Children under 2 years of age: ask a doctor. To apply to face, spray into palm of hand and gently apply."],"spl_product_data_elements":["Equate Calaspray Pramoxine HCl 1%, Zinc Acetate 0.1% PHENOXYETHANOL WATER HYPROMELLOSE, UNSPECIFIED CITRIC ACID MONOHYDRATE CAMPHOR (SYNTHETIC) ETHYLHEXYLGLYCERIN PROPYLENE GLYCOL SODIUM CITRATE ALCOHOL PRAMOXINE HYDROCHLORIDE PRAMOXINE ZINC ACETATE ZINC CATION POLYSORBATE 40"],"keep_out_of_reach_of_children":["If product is swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away."],"package_label_principal_display_panel":["Label"]},"tags":[{"label":"zinc acetate","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"A16AX05","category":"atc"},{"label":"Topical","category":"route"},{"label":"Oral","category":"route"},{"label":"Aerosol","category":"form"},{"label":"Capsule","category":"form"},{"label":"Cream","category":"form"},{"label":"Off-Patent","category":"patent"},{"label":"Active","category":"status"},{"label":"Arthropod bite wound","category":"indication"},{"label":"Burn injury","category":"indication"},{"label":"Diaper rash","category":"indication"},{"label":"Eruption of skin","category":"indication"},{"label":"Hemorrhoids","category":"indication"},{"label":"Hypozincemia","category":"indication"},{"label":"Eton","category":"company"},{"label":"Approved 1980s","category":"decade"}],"phase":"marketed","safety":{"boxedWarnings":[],"safetySignals":[{"llr":142.491,"date":"","count":39,"signal":"Anosmia","source":"DrugCentral FAERS","actionTaken":"Reported 39 times (LLR=142)"},{"llr":51.931,"date":"","count":22,"signal":"Ageusia","source":"DrugCentral FAERS","actionTaken":"Reported 22 times (LLR=52)"},{"llr":38.058,"date":"","count":13,"signal":"Urine odour abnormal","source":"DrugCentral FAERS","actionTaken":"Reported 13 times (LLR=38)"},{"llr":28.228,"date":"","count":5,"signal":"Corneal neovascularisation","source":"DrugCentral FAERS","actionTaken":"Reported 5 times (LLR=28)"},{"llr":26.978,"date":"","count":4,"signal":"Skin degenerative disorder","source":"DrugCentral FAERS","actionTaken":"Reported 4 times (LLR=27)"},{"llr":25.071,"date":"","count":10,"signal":"Urine abnormality","source":"DrugCentral FAERS","actionTaken":"Reported 10 times (LLR=25)"},{"llr":24.876,"date":"","count":6,"signal":"Hyposmia","source":"DrugCentral FAERS","actionTaken":"Reported 6 times (LLR=25)"},{"llr":24.737,"date":"","count":10,"signal":"Hepatic enzyme abnormal","source":"DrugCentral FAERS","actionTaken":"Reported 10 times (LLR=25)"},{"llr":22.759,"date":"","count":9,"signal":"Wheelchair user","source":"DrugCentral FAERS","actionTaken":"Reported 9 times (LLR=23)"},{"llr":21.02,"date":"","count":12,"signal":"Mental impairment","source":"DrugCentral FAERS","actionTaken":"Reported 12 times (LLR=21)"},{"llr":20.133,"date":"","count":5,"signal":"Corneal perforation","source":"DrugCentral FAERS","actionTaken":"Reported 5 times (LLR=20)"},{"llr":19.848,"date":"","count":6,"signal":"Proteus infection","source":"DrugCentral FAERS","actionTaken":"Reported 6 times (LLR=20)"}],"commonSideEffects":[{"effect":"Gastric irritation","drugRate":"","severity":"common","organSystem":""},{"effect":"Elevations of serum alkaline phosphatase","drugRate":"","severity":"common","organSystem":""},{"effect":"Elevations of serum amylase","drugRate":"","severity":"common","organSystem":""},{"effect":"Elevations of serum lipase","drugRate":"","severity":"common","organSystem":""}],"contraindications":["Denuded skin","Hypocupremia","Infective otitis media","Open wound","Perforation of tympanic membrane","Porphyria"],"specialPopulations":{"Pregnancy":"If this drug is used during pregnancy, the possibility of fetal harm appears remote. Because studies cannot rule out the possibility of harm, however, zinc acetate should be used during pregnancy only if clearly needed.","Paediatric use":"Results of observations in small number of patients in the two clinical trials suggest that pediatric patients aged 10 years and above can be adequately maintained at doses between 75 to 150 mg elemental zinc daily in divided doses. No patients below the age of 10 years have been studied."},"seriousAdverseEvents":[{"effect":"Pancreatitis","drugRate":"","severity":"serious"}]},"trials":[],"aliases":[],"company":"Eton","patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=ZINC ACETATE","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T04:09:29.914577+00:00"},"timeline":{"url":"https://en.wikipedia.org/wiki/Zinc Acetate","method":"deterministic","source":"Wikipedia","rawText":"","confidence":0.8,"sourceType":"wikipedia","retrievedAt":"2026-04-20T04:09:36.633720+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T04:09:34.969679+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=ZINC ACETATE","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T04:09:35.157171+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T04:09:28.810002+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (no boxed warning)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T04:09:28.810035+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL3184986/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T04:09:36.301063+00:00"},"regulatory.fda_application":{"url":"","method":"deterministic","source":"FDA Label","rawText":"M017","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T04:09:28.810040+00:00"}},"allNames":"galzin","offLabel":[],"synonyms":["zinc acetate anhydrous","zinc acetate dihydrate","wilzin","zinc acetate","zinc diacetate","zinc acetate hydrate","nobelzin"],"timeline":[{"date":"1980-01-01","type":"neutral","source":"FDA Orange Book","milestone":"Rights transferred from ARMOUR PHARM to Eton"},{"date":"1980-02-22","type":"positive","source":"DrugCentral","milestone":"FDA approval (Armour Pharm)"},{"date":"2021-01-22","type":"positive","source":"DrugCentral","milestone":"PMDA approval (NOBELPHARMA Co., Ltd)"}],"aiSummary":"Galzin (ZINC ACETATE) is a small molecule drug developed by ARMOUR PHARM and currently owned by Eton. It was FDA approved in 1980 for various indications including arthropod bite wounds, burn injuries, and hemorrhoids. Galzin is classified as a zinc acetate and is off-patent, meaning it is no longer protected by active patents. It is used to treat conditions related to zinc deficiency or insufficiency. As an off-patent drug, Galzin is available from various manufacturers.","approvals":[{"date":"1980-02-22","orphan":false,"company":"ARMOUR PHARM","regulator":"FDA"},{"date":"2021-01-22","orphan":false,"company":"NOBELPHARMA Co., Ltd","regulator":"PMDA"}],"brandName":"Galzin","ecosystem":[{"indication":"Arthropod bite wound","otherDrugs":[{"name":"dexpanthenol","slug":"dexpanthenol","company":"Hospira"},{"name":"ferric oxide","slug":"ferric-oxide","company":""},{"name":"pramocaine","slug":"pramocaine","company":"Sebela Ireland Ltd"},{"name":"zinc oxide","slug":"zinc-oxide","company":"Delcor Asset"}],"globalPrevalence":null},{"indication":"Burn injury","otherDrugs":[{"name":"ferric oxide","slug":"ferric-oxide","company":""},{"name":"pramocaine","slug":"pramocaine","company":"Sebela Ireland Ltd"},{"name":"zinc oxide","slug":"zinc-oxide","company":"Delcor Asset"}],"globalPrevalence":null},{"indication":"Diaper rash","otherDrugs":[{"name":"amphotericin B","slug":"amphotericin-b","company":"Apothecon"},{"name":"clotrimazole","slug":"clotrimazole","company":""},{"name":"dexpanthenol","slug":"dexpanthenol","company":"Hospira"},{"name":"dimethicone","slug":"dimethicone","company":"Mcneil"}],"globalPrevalence":null},{"indication":"Eruption of skin","otherDrugs":[{"name":"alclometasone dipropionate","slug":"alclometasone-dipropionate","company":""},{"name":"amcinonide","slug":"amcinonide","company":"Astellas"},{"name":"ammonium lactate","slug":"ammonium-lactate","company":"Ranbaxy"},{"name":"benzoyl peroxide","slug":"benzoyl-peroxide","company":"Valeant Intl"}],"globalPrevalence":null},{"indication":"Hemorrhoids","otherDrugs":[{"name":"cortisone acetate","slug":"cortisone-acetate","company":""},{"name":"ferric oxide","slug":"ferric-oxide","company":""},{"name":"hydrocortisone","slug":"hydrocortisone","company":"Merck"},{"name":"hydrocortisone acetate","slug":"hydrocortisone-acetate","company":"Merck"}],"globalPrevalence":null},{"indication":"Hypozincemia","otherDrugs":[],"globalPrevalence":null},{"indication":"Itching of ear","otherDrugs":[{"name":"benzalkonium","slug":"benzalkonium","company":""},{"name":"cortisone acetate","slug":"cortisone-acetate","company":""},{"name":"hydrocortisone","slug":"hydrocortisone","company":"Merck"},{"name":"pramocaine","slug":"pramocaine","company":"Sebela Ireland Ltd"}],"globalPrevalence":null},{"indication":"Itching of skin","otherDrugs":[{"name":"alimemazine","slug":"alimemazine","company":"Allergan Herbert"},{"name":"allantoin","slug":"allantoin","company":""},{"name":"ammonium lactate","slug":"ammonium-lactate","company":"Ranbaxy"},{"name":"antazoline","slug":"antazoline","company":"Novartis"}],"globalPrevalence":null}],"mechanism":{"novelty":"First-in-class","modality":"Small Molecule","drugClass":"zinc acetate","explanation":"","oneSentence":"","technicalDetail":"Galzin (zinc acetate) acts as a zinc supplement, increasing zinc levels in the body by providing a readily available source of this essential mineral. Zinc plays a crucial role in numerous biological processes, including protein synthesis, DNA replication, and immune function."},"_wikipedia":{"url":"https://en.wikipedia.org/wiki/Am%C3%A9d%C3%A9e_Galzin","title":"Amédée Galzin","extract":"Amédée Galzin was a French veterinarian and mycologist."},"commercial":{"launchDate":"1980","_launchSource":"DrugCentral (FDA 1980-02-22, ARMOUR PHARM)"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/4269","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=ZINC%20ACETATE","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=ZINC ACETATE","fields":["publications"],"source":"PubMed/NCBI"},{"id":4,"url":"https://en.wikipedia.org/wiki/Am%C3%A9d%C3%A9e_Galzin","fields":["history","overview"],"source":"Wikipedia"},{"id":5,"url":"https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files","fields":["patents","exclusivity","genericManufacturers"],"source":"FDA Orange Book"}],"_enrichedAt":"2026-03-30T16:11:45.440700","_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T04:09:38.271424+00:00","fieldsConflicting":2,"overallConfidence":0.8},"biosimilars":[],"competitors":[{"drugName":"thioctic acid","drugSlug":"thioctic-acid","fdaApproval":"","relationship":"same-class"},{"drugName":"phenylbutanoic acid","drugSlug":"phenylbutanoic-acid","fdaApproval":"1996-04-30","relationship":"same-class"},{"drugName":"nitisinone","drugSlug":"nitisinone","fdaApproval":"2002-01-18","patentExpiry":"Jan 5, 2035","patentStatus":"Patent 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benzoate","drugSlug":"sodium-benzoate","fdaApproval":"1987-12-23","relationship":"same-class"},{"drugName":"trientine","drugSlug":"trientine","fdaApproval":"1985-11-08","genericCount":13,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"uridine triacetate","drugSlug":"uridine-triacetate","fdaApproval":"2015-09-04","patentExpiry":"Aug 17, 2027","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"migalastat","drugSlug":"migalastat","fdaApproval":"2018-08-08","patentExpiry":"Oct 20, 2031","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"givosiran","drugSlug":"givosiran","fdaApproval":"2019-11-20","patentExpiry":"Oct 3, 2034","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"triheptanoin","drugSlug":"triheptanoin","fdaApproval":"2020-06-30","patentExpiry":"Nov 14, 2034","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"lumasiran","drugSlug":"lumasiran","fdaApproval":"2020-11-23","patentExpiry":"Oct 9, 2035","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"fosdenopterin","drugSlug":"fosdenopterin","fdaApproval":"2021-02-26","patentExpiry":"Apr 9, 2029","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"lonafarnib","drugSlug":"lonafarnib","fdaApproval":"2020-11-20","patentExpiry":"Jul 26, 2029","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"phenylacetic acid","drugSlug":"phenylacetic-acid","fdaApproval":"1987-12-23","relationship":"same-class"}],"genericName":"zinc acetate","indications":{"approved":[{"name":"Arthropod bite wound","source":"DrugCentral","snomedId":409985002,"regulator":"FDA","eligibility":"No specific eligibility criteria mentioned"},{"name":"Burn injury","source":"DrugCentral","snomedId":48333001,"regulator":"FDA","eligibility":"No specific eligibility criteria mentioned"},{"name":"Diaper rash","source":"DrugCentral","snomedId":91487003,"regulator":"FDA","eligibility":"No specific eligibility criteria mentioned"},{"name":"Eruption of skin","source":"DrugCentral","snomedId":271807003,"regulator":"FDA","eligibility":"No specific eligibility criteria mentioned"},{"name":"Hemorrhoids","source":"DrugCentral","snomedId":70153002,"regulator":"FDA","eligibility":"No specific eligibility criteria mentioned"},{"name":"Hypozincemia","source":"DrugCentral","snomedId":238124008,"regulator":"FDA","eligibility":"No specific eligibility criteria mentioned"},{"name":"Itching of ear","source":"DrugCentral","snomedId":699392007,"regulator":"FDA","eligibility":"No specific eligibility criteria mentioned"},{"name":"Itching of skin","source":"DrugCentral","snomedId":418363000,"regulator":"FDA","eligibility":"No specific eligibility criteria mentioned"},{"name":"Otitis externa","source":"DrugCentral","snomedId":3135009,"regulator":"FDA","eligibility":"No specific eligibility criteria mentioned"},{"name":"Proctitis","source":"DrugCentral","snomedId":3951002,"regulator":"FDA","eligibility":"No specific eligibility criteria mentioned","usPrevalence":null,"globalPrevalence":2800000,"prevalenceMethod":"curated","prevalenceSource":"Orphanet (European Medicines Agency[INST])"},{"name":"Rectal pain","source":"DrugCentral","snomedId":77880009,"regulator":"FDA"},{"name":"Skin irritation","source":"DrugCentral","snomedId":367466007,"regulator":"FDA"},{"name":"Wilson's disease","source":"DrugCentral","snomedId":88518009,"regulator":"FDA"},{"name":"Wound","source":"DrugCentral","snomedId":13924000,"regulator":"FDA"}],"offLabel":[{"name":"Impacted cerumen","source":"DrugCentral","drugName":"ZINC ACETATE","evidenceCount":0,"evidenceLevel":"emerging"},{"name":"Otalgia","source":"DrugCentral","drugName":"ZINC ACETATE","evidenceCount":0,"evidenceLevel":"emerging"}],"pipeline":[]},"currentOwner":"Eton","drugCategory":"active","labelChanges":[],"patentStatus":"Off-patent — no active Orange Book patents","relatedDrugs":[{"drugId":"thioctic-acid","brandName":"thioctic acid","genericName":"thioctic acid","approvalYear":"","relationship":"same-class"},{"drugId":"phenylbutanoic-acid","brandName":"phenylbutanoic acid","genericName":"phenylbutanoic acid","approvalYear":"1996","relationship":"same-class"},{"drugId":"nitisinone","brandName":"nitisinone","genericName":"nitisinone","approvalYear":"2002","relationship":"same-class"},{"drugId":"miglustat","brandName":"miglustat","genericName":"miglustat","approvalYear":"2003","relationship":"same-class"},{"drugId":"sapropterin","brandName":"sapropterin","genericName":"sapropterin","approvalYear":"2007","relationship":"same-class"},{"drugId":"teduglutide","brandName":"teduglutide","genericName":"teduglutide","approvalYear":"2012","relationship":"same-class"},{"drugId":"glycerol-phenylbutyrate","brandName":"glycerol phenylbutyrate","genericName":"glycerol phenylbutyrate","approvalYear":"2013","relationship":"same-class"},{"drugId":"eliglustat","brandName":"eliglustat","genericName":"eliglustat","approvalYear":"2014","relationship":"same-class"},{"drugId":"sodium-benzoate","brandName":"sodium benzoate","genericName":"sodium benzoate","approvalYear":"1987","relationship":"same-class"},{"drugId":"trientine","brandName":"trientine","genericName":"trientine","approvalYear":"1985","relationship":"same-class"}],"trialDetails":[{"nctId":"NCT06412653","phase":"PHASE2","title":"Prospective Pilot Trial to Address Feasibility and Safety of Oral Zinc in GNAO1 Associated Disorders","status":"COMPLETED","sponsor":"Children's University Hospital Cologne, Germany","startDate":"2024-08-02","conditions":["GNAO1","Dystonia","Epilepsy","Development Delay","Developmental and Epileptic Encephalopathy 17","Neurodevelopmental Disorder With Involuntary Movements","Choreoathetosis"],"enrollment":13,"completionDate":"2025-08-04"},{"nctId":"NCT05682261","phase":"NA","title":"The Effect of Multiple Micronutrient Supplements in Reducing Anemia in Women of Reproductive Age","status":"COMPLETED","sponsor":"Ethiopian Public Health Institute","startDate":"2023-03-23","conditions":["Anemia"],"enrollment":265,"completionDate":"2023-10-17"},{"nctId":"NCT05359835","phase":"EARLY_PHASE1","title":"DTPA (Diethylenetriaminepenta-acetate) Chelation for Symptoms After Gadolinium-assisted MRI Exposure","status":"WITHDRAWN","sponsor":"Stanford University","startDate":"2023-04-11","conditions":["Gadolinium Deposition Disease"],"enrollment":0,"completionDate":"2024-09-13"},{"nctId":"NCT00212355","phase":"PHASE3","title":"Efficacy and Safety, Long-term Study of Zinc Acetate to Treat Wilson's Disease in Japan.","status":"COMPLETED","sponsor":"Nobelpharma","startDate":"2005-03","conditions":["Wilson's Disease"],"enrollment":37,"completionDate":"2009-01"},{"nctId":"NCT05708183","phase":"","title":"Healthy Mums, Healthy Babies: Multiple Micronutrient Supplementation in Ethiopia","status":"RECRUITING","sponsor":"London School of Hygiene and Tropical Medicine","startDate":"2023-01-01","conditions":["Birth 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