{"id":"sulfacetamide","rwe":[],"_fda":{"id":"4839d73b-3ff1-a903-e063-6294a90a2851","set_id":"02acb079-f3b3-49f2-b1d9-4fc1553f72a9","openfda":{"unii":["4NRT660KJQ","70FD1KFU70"],"route":["TOPICAL"],"rxcui":["1005856"],"spl_id":["4839d73b-3ff1-a903-e063-6294a90a2851"],"brand_name":["SODIUM SULFACETAMIDE AND SULFUR"],"spl_set_id":["02acb079-f3b3-49f2-b1d9-4fc1553f72a9"],"package_ndc":["44523-607-01","44523-607-02"],"product_ndc":["44523-607"],"generic_name":["SULFACETAMIDE SODIUM, SULFUR"],"product_type":["HUMAN PRESCRIPTION DRUG"],"substance_name":["SULFACETAMIDE SODIUM","SULFUR"],"manufacturer_name":["BioComp Pharma, Inc."],"is_original_packager":[true]},"version":"7","warnings":["WARNINGS: Sulfonamides are known to cause Stevens-Johnson syndrome in hypersensitive individuals. Stevens-Johnson syndrome also has been reported following the use of sodium sulfacetamide topically. Cases of drug-induced systemic lupus erythematosus from topical sulfacetamide also have been reported. In one of these cases, there was a fatal outcome. KEEP OUT OF THE REACH OF CHILDREN."],"overdosage":["OVERDOSAGE: The oral LD 50 of sulfacetamide in mice is 16.5 g/kg. In the event of overdosage, emergency treatment should be started immediately. Manifestations: Overdosage may cause nausea and vomiting. Large oral overdosage may cause hematuria, crystalluria and renal shutdown due to the precipitation of sulfa crystals in the renal tubules and the urinary tract. For treatment, contact your local Poison Control Center or your doctor."],"description":["DESCRIPTION: Each gram contains 100 mg of sodium sulfacetamide and 50 mg of colloidal sulfur in a vehicle consisting of: benzyl alcohol, cetyl alcohol, disodium EDTA, fragrance, glyceryl stearate (and) PEG-100 stearate, magnesium aluminum silicate, PEG-150 distearate, phenoxyethanol, polyethylene glycol 400, purified water, sodium lauryl sulfate, sodium thiosulfate, stearyl alcohol and xanthan gum. Sodium sulfacetamide is a sulfonamide with antibacterial activity while sulfur acts as a keratolytic agent. Sodium sulfacetamide is C 8 H 9 N 2 NaO 3 S·H 2 O with molecular weight of 254.24. Chemically, sodium sulfacetamide is N-[(4-aminophenyl) sulfonyl]-acetamide, monosodium salt, monohydrate. The structural formula is: Sodium sulfacetamide is an odorless, white, crystalline powder with a bitter taste. It is freely soluble in water, sparingly soluble in alcohol, while practically insoluble in benzene, in chloroform and in ether. structure"],"precautions":["PRECAUTIONS: FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. General: Nonsusceptible organisms, including fungi, may proliferate with the use of this preparation. Although rare, sensitivity to sodium sulfacetamide may occur. Therefore, caution and careful supervision should be observed when prescribing this drug for patients who may be prone to hypersensitivity to topical sulfonamides. If the use of this product produces signs of hypersensitivity or other untoward reactions, discontinue use of the preparation. Patients should be carefully observed for possible local irritation or sensitization during long-term therapy. Systemic toxic reactions such as agranulocytosis, acute hemolytic anemia, purpura hemorrhagica, drug fever, jaundice and contact dermatitis indicate hypersensitivity to sulfonamides. Particular caution should be employed if areas of denuded or abraded skin are involved. Systemic absorption of topical sulfonamides is greater following application to large, infected, abraded, denuded or severely burned areas. Under these circumstances, any of the adverse effects produced by the systemic administration of these agents could potentially occur, and appropriate observations and laboratory determinations should be performed. The object of this therapy is to achieve desquamation without irritation, but sodium sulfacetamide and sulfur can cause reddening and scaling of the epidermis. These side effects are not unusual in the treatment of acne vulgaris, but patients should be cautioned about the possibility. Information for Patients: Patients should discontinue the use of this product if the condition becomes worse or if a rash develops in the area being treated or elsewhere. The use of this product should also be discontinued promptly and the physician notified if any arthritis, fever or sores in the mouth develop. Avoid contact with eyes, lips and mucous membranes. Drug Interactions: This product is incompatible with silver preparations. Carcinogenesis, Mutagenesis and Impairment of Fertility: Long-term animal studies for carcinogenic potential have not been performed on this product to date. Studies on reproduction and fertility also have not been performed. Chromosomal nondisjunction has been reported in the yeast, Saccharomyces cerevisiae, following application of sodium sulfacetamide. The significance of this finding to the topical use of sodium sulfacetamide in the human is unknown. Pregnancy: Category C. Animal reproduction studies have not been conducted with this product. It is also not known whether this product can affect reproduction capacity or cause fetal harm when administered to a pregnant woman. This product should be used by a pregnant woman only if clearly needed or when potential benefits outweigh potential hazards to the fetus. Nursing Mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when this product is administered to a nursing woman. Pediatric Use: Safety and effectiveness in children under the age of 12 years have not been established."],"how_supplied":["HOW SUPPLIED: This product is supplied in the following size(s): 30 g bottles, NDC 44523-607-01 60 g bottles, NDC 44523-607-02 To report a serious adverse event or obtain product information, call 1-866-762-2365. Manufactured for: BIOCOMP PHARMA ® , INC. San Antonio, TX 78230 1355 826097 I826097R0315"],"effective_time":"20260112","adverse_reactions":["ADVERSE REACTIONS: Reports of irritation and hypersensitivity to sodium sulfacetamide are uncommon. The following adverse reactions, reported after administration of sterile ophthalmic sodium sulfacetamide, are noteworthy: instances of Stevens-Johnson syndrome and instances of local hypersensitivity which progressed to a syndrome resembling systemic lupus erythematosus; in one case a fatal outcome was reported (see WARNINGS)."],"contraindications":["CONTRAINDICATIONS: This product is contraindicated in persons with known or suspected hypersensitivity to any of the ingredients of the product. This product is not to be used by patients with kidney disease."],"storage_and_handling":["STORAGE: Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (between 59°F and 86°F). Brief exposure to temperatures up to 40°C (104°F) may be tolerated provided the mean kinetic temperature does not exceed 25°C (77°F); however, such exposure should be minimized. NOTICE: Protect from freezing and excessive heat. The product may tend to darken slightly on storage. Slight discoloration does not impair the efficacy or safety of the product. Keep dispensing container tightly closed. Occasionally, a slight discoloration of fabric may occur when an excessive amount of the product is used and comes in contact with white fabrics. This discoloration, however, presents no problem, as it is readily removed by ordinary laundering without bleaches."],"clinical_pharmacology":["CLINICAL PHARMACOLOGY: Sodium sulfacetamide exerts a bacteriostatic effect against sulfonamide sensitive Gram-positive and Gram-negative microorganisms commonly isolated from secondary cutaneous pyogenic infections. It acts by restricting the synthesis of folic acid required by bacteria for growth, by its competition with para-aminobenzoic acid. There is no clinical data available on the degree and rate of systemic absorption of this product when applied to the skin or scalp. However, significant absorption of sodium sulfacetamide through the skin has been reported. The following in vitro data is available but the clinical significance is unknown. Organisms that show susceptibility to sodium sulfacetamide are: Streptococci, Staphylococci, E. coli, Klebsiella pneumoniae, Pseudomonas pyocyanea, Salmonella species, Proteus vulgaris, Nocardia and Actinomyces. The exact mode of action of sulfur in the treatment of acne is unknown, but it has been reported that it inhibits the growth of Propionibacterium acnes and the formation of free fatty acids."],"indications_and_usage":["INDICATIONS: This product is indicated for use in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis."],"spl_unclassified_section":["Rx Only FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE."],"dosage_and_administration":["DOSAGE AND ADMINISTRATION: Cleanse affected areas. Apply a thin layer to the affected areas with light massaging, 1 to 3 times daily or as directed by a physician."],"spl_product_data_elements":["SODIUM SULFACETAMIDE AND SULFUR SULFACETAMIDE SODIUM, SULFUR PEG-150 DISTEARATE BENZYL ALCOHOL CETYL ALCOHOL EDETATE SODIUM GLYCERYL MONOSTEARATE PEG-100 STEARATE PHENOXYETHANOL SODIUM THIOSULFATE WATER XANTHAN GUM POLYETHYLENE GLYCOL 400 SODIUM LAURYL SULFATE STEARYL ALCOHOL MAGNESIUM ALUMINUM SILICATE SULFACETAMIDE SODIUM SULFACETAMIDE SULFUR SULFUR"],"package_label_principal_display_panel":["carton1.jpg carton2.jpg"]},"tags":[{"label":"Sulfonamide Antibacterial","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"Dihydrofolate reductase","category":"target"},{"label":"DHFR","category":"gene"},{"label":"D10AF06","category":"atc"},{"label":"Topical","category":"route"},{"label":"Aerosol","category":"form"},{"label":"Cloth","category":"form"},{"label":"Cream","category":"form"},{"label":"Off-Patent","category":"patent"},{"label":"Generic Available","category":"availability"},{"label":"Established","category":"status"},{"label":"Acne vulgaris","category":"indication"},{"label":"Amebic infection","category":"indication"},{"label":"Blepharoconjunctivitis","category":"indication"},{"label":"Chlamydial conjunctivitis","category":"indication"},{"label":"Gardnerella Vaginalis Bacterial Vaginosis","category":"indication"},{"label":"Infective blepharitis","category":"indication"},{"label":"Schering","category":"company"},{"label":"Approved 1940s","category":"decade"},{"label":"Anti-Bacterial Agents","category":"pharmacology"},{"label":"Anti-Infective Agents","category":"pharmacology"},{"label":"Anti-Infective Agents, Local","category":"pharmacology"},{"label":"Anti-Infective Agents, Urinary","category":"pharmacology"}],"phase":"marketed","safety":{"boxedWarnings":[],"safetySignals":[{"date":"","signal":"DRUG INEFFECTIVE","source":"FDA FAERS","actionTaken":"67 reports"},{"date":"","signal":"DRUG HYPERSENSITIVITY","source":"FDA FAERS","actionTaken":"66 reports"},{"date":"","signal":"NAUSEA","source":"FDA FAERS","actionTaken":"46 reports"},{"date":"","signal":"PAIN","source":"FDA FAERS","actionTaken":"40 reports"},{"date":"","signal":"HEADACHE","source":"FDA FAERS","actionTaken":"37 reports"},{"date":"","signal":"DYSPNOEA","source":"FDA FAERS","actionTaken":"36 reports"},{"date":"","signal":"OFF LABEL USE","source":"FDA FAERS","actionTaken":"36 reports"},{"date":"","signal":"RASH","source":"FDA FAERS","actionTaken":"34 reports"},{"date":"","signal":"FATIGUE","source":"FDA FAERS","actionTaken":"30 reports"},{"date":"","signal":"WEIGHT DECREASED","source":"FDA FAERS","actionTaken":"26 reports"}],"commonSideEffects":[{"effect":"Stevens-Johnson syndrome","drugRate":"reported","severity":"unknown"},{"effect":"Local hypersensitivity","drugRate":"reported","severity":"unknown"},{"effect":"Syndrome resembling systemic lupus erythematosus","drugRate":"reported","severity":"unknown"}],"contraindications":["Anemia due to enzyme deficiency","Angle-closure glaucoma","Arterial aneurysm","Arteriosclerotic vascular disease","Bacterial infection of eye","Benign prostatic hyperplasia","Breastfeeding (mother)","Conduction disorder of the heart","Deficiency of glucose-6-phosphate dehydrogenase","Denuded skin","Diabetes mellitus","Disease of blood AND/OR blood-forming organ","Disease of liver","Disorder of coronary artery","Eruption of skin","Eye infection","Fungal infection of eye","Heart disease","Herpes simplex dendritic keratitis","Herpes simplex keratitis","Hypertensive disorder","Hyperthyroidism","Kidney disease","Krukenberg spindle","Ocular hypertension"],"specialPopulations":{"Pregnancy":"Teratorgenic effects. Pregnancy Category C. Kernicterus may occur in the newborn as result of treatment of pregnant woman at term with orally administered sulfonamides. There are no adequate and well controlled studies of sulfonamide ophthalmic preparations in pregnant women and it is not known whether topically applied sulfonamides can cause fetal harm when administered to pregnant woman.","Paediatric use":"Safety and effectiveness in children under the age of 12 years have not been established."}},"trials":[],"aliases":[],"company":"Merck & Co.","patents":[],"pricing":[{"market":"United States","source":"CMS National Average Drug Acquisition Cost (NADAC)","asOfDate":"2024-01-03","unitCost":"$2.1149/ML","priceType":"NADAC","sourceUrl":"https://data.medicaid.gov/dataset/4j6z-xnwq","annualCost":"$761","description":"SULFACETAMIDE 10% EYE DROPS","retrievedDate":"2026-04-07"}],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=SULFACETAMIDE","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T00:34:21.085541+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T00:34:32.155942+00:00"},"regulatory.us":{"url":"","method":"api_direct","source":"FDA Drugs@FDA","rawText":"","confidence":1,"sourceType":"fda_drugsfda","retrievedAt":"2026-04-20T00:34:19.716929+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=SULFACETAMIDE","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T00:34:32.931966+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:34:18.002135+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (no boxed warning)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:34:18.002194+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":"2026-04-20T00:34:34.401611+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: Bacterial dihydropteroate synthase inhibitor","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T00:34:33.499628+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL455/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T00:34:33.396849+00:00"}},"allNames":"klaron","offLabel":[],"synonyms":["sulfacetamide","acetosulfamin","acetosulfamine","formosulfacetamide","N-Acetylsulfanilamide","N-Sulfanilylacetamide","sulfacet","sulfacetimide","sulphacetamide","sulfacetamide sodium","sulfacetamide sodic hydrate"],"timeline":[{"date":"1945-01-01","type":"neutral","source":"FDA Orange Book","milestone":"Rights transferred from ORTHO MCNEIL PHARM to Schering"},{"date":"1945-09-12","type":"positive","source":"DrugCentral","milestone":"FDA approval (Ortho Mcneil Pharm)"},{"date":"1996-12-23","type":"positive","source":"FDA Orange Book","milestone":"Klaron approved — 10%"}],"aiSummary":"Klaron (SULFACETAMIDE) is a sulfonamide antibacterial small molecule drug originally developed by ORTHO MCNEIL PHARM and currently owned by Schering. It targets dihydrofolate reductase and has been FDA-approved since 1945 for various indications including acne vulgaris, amebic infection, and blepharoconjunctivitis. Klaron is off-patent with 15 generic manufacturers available. Key safety considerations include its antibacterial properties which may contribute to antibiotic resistance. As a sulfonamide, it may also cause hypersensitivity reactions in some individuals.","approvals":[{"date":"1945-09-12","orphan":false,"company":"ORTHO MCNEIL PHARM","regulator":"FDA"}],"brandName":"Klaron","ecosystem":[{"indication":"Acne vulgaris","otherDrugs":[{"name":"adapalene","slug":"adapalene","company":"Galderma Labs Lp"},{"name":"ammonia","slug":"ammonia","company":""},{"name":"amphotericin B","slug":"amphotericin-b","company":"Apothecon"},{"name":"azelaic acid","slug":"azelaic-acid","company":"Allergan"}],"globalPrevalence":null},{"indication":"Amebic infection","otherDrugs":[{"name":"diiodohydroxyquinoline","slug":"diiodohydroxyquinoline","company":""}],"globalPrevalence":null},{"indication":"Blepharoconjunctivitis","otherDrugs":[{"name":"Polymyxin B","slug":"polymyxin-b","company":"Monarch Pharms"},{"name":"bacitracin","slug":"bacitracin","company":"Pharmacia And Upjohn"},{"name":"cortisone 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acetate","slug":"cortisone-acetate","company":""},{"name":"dexamethasone","slug":"dexamethasone","company":""}],"globalPrevalence":null},{"indication":"Iridocyclitis","otherDrugs":[{"name":"cortisone acetate","slug":"cortisone-acetate","company":""},{"name":"dexamethasone","slug":"dexamethasone","company":""},{"name":"fluorometholone","slug":"fluorometholone","company":"Allergan"},{"name":"fluorometholone acetate","slug":"fluorometholone-acetate","company":"Alcon"}],"globalPrevalence":40000},{"indication":"Pityriasis simplex","otherDrugs":[{"name":"allantoin","slug":"allantoin","company":""},{"name":"ammonia","slug":"ammonia","company":""},{"name":"carbamide","slug":"carbamide","company":"Hospira"},{"name":"chloroxine","slug":"chloroxine","company":""}],"globalPrevalence":null}],"mechanism":{"target":"Dihydrofolate reductase","novelty":"First-in-class","targets":[{"gene":"DHFR","source":"DrugCentral","target":"Dihydrofolate reductase","protein":"Dihydrofolate reductase"}],"modality":"Small Molecule","drugClass":"Sulfonamide Antibacterial","explanation":"","oneSentence":"","technicalDetail":"Klaron (SULFACETAMIDE) competitively inhibits dihydrofolate reductase, an enzyme crucial for the synthesis of tetrahydrofolate, a necessary precursor for thymidylate synthesis and ultimately DNA replication in bacteria."},"commercial":{"launchDate":"1945","_launchSource":"DrugCentral (FDA 1945-09-12, ORTHO MCNEIL 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keratitis","source":"DrugCentral","drugName":"SULFACETAMIDE","evidenceCount":10,"evidenceLevel":"emerging"},{"name":"Rosacea","source":"DrugCentral","drugName":"SULFACETAMIDE"}],"pipeline":[]},"currentOwner":"Schering","drugCategory":"established","labelChanges":[],"patentStatus":"Off-patent — no active Orange Book 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Ciolino, MD","startDate":"2014-10","conditions":["Meibomian Gland Dysfunction"],"enrollment":45,"completionDate":"2015-08"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"administration":{"route":"Topical","formulation":"Aerosol, Cloth, Cream","formulations":[{"form":"AEROSOL, FOAM","route":"TOPICAL","productName":"Sodium Sulfacetamide 10% and Sulfur 5% Emollient Foam"},{"form":"AEROSOL, FOAM","route":"TOPICAL","productName":"Ovace\nPlus"},{"form":"CLOTH","route":"TOPICAL","productName":"Sumaxin Cleansing Pads"},{"form":"CLOTH","route":"TOPICAL","productName":"Plexion"},{"form":"CLOTH","route":"TOPICAL","productName":"SULFACETAMIDE SODIUM, SULFUR"},{"form":"CLOTH","route":"TOPICAL","productName":"Sodium Sulfacetamide, Sulfur"},{"form":"CREAM","route":"TOPICAL","productName":"Sodium Sulfacetamide and Sulfur Cleanser"},{"form":"CREAM","route":"TOPICAL","productName":"Sulfacetamide Sodium and Sulfur"},{"form":"CREAM","route":"TOPICAL","productName":"Sumadan 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