{"adverse_reactions":["ADVERSE REACTIONS: In the controlled clinical trial with 89 patients using ciclopirox olamine topical suspension and 89 patients using the vehicle, the incidence of adverse reactions was low. Those considered possibly related to treatment or occurring in more than one patient were pruritus, which occurred in two patients using ciclopirox olamine suspension and one patient using the suspension vehicle, and burning, which occurred in one patient using ciclopirox olamine suspension."],"carcinogenesis_and_mutagenesis_and_impairment_of_fertility":["Carcinogenesis, Mutagenesis, Impairment of Fertility A 104-week dermal carcinogenicity study in mice was conducted with ciclopirox cream applied at doses up to 1.93% (100 mg/kg/day or 300 mg/m 2 /day). No increase in drug related neoplasms was noted when compared to control. The following in vitro genotoxicity tests have been conducted with ciclopirox: evaluation of gene mutation in the Ames Salmonella and E. coli assays (negative); chromosome aberration assays in V79 Chinese hamster lung fibroblast cells, with and without metabolic activation (positive); chromosome aberration assays in V79 Chinese hamster lung fibroblast cells in the presence of supplemental Fe 3+ , with and without metabolic activation (negative); gene mutation assays in the HGPRT-test with V79 Chinese hamster lung fibroblast cells (negative); and a primary DNA damage assay (i.e., unscheduled DNA synthesis assay in A549 human cells) (negative). An in vitro cell transformation assay in BALB/c 3T3 cells was negative for cell transformation. In an in vitro Chinese hamster bone marrow cytogenetic assay, ciclopirox was negative for chromosome aberrations at a dosage of 5000 mg/kg body weight. A combined oral fertility and embryofetal developmental study was conducted in rats with ciclopirox olamine. No effect on fertility or reproductive performance was noted at the highest dose tested of 3.85 mg/kg/day ciclopirox (approximately 1.2 times the maximum recommended human dose based on body surface area comparisons)."],"clinical_pharmacology":["CLINICAL PHARMACOLOGY Mechanism of Action Ciclopirox is a hydroxypyridone antifungal agent that acts by chelation of polyvalent cations (Fe 3+ or Al 3+ ), resulting in the inhibition of the metal-dependent enzymes that are responsible for the degradation of peroxides within the fungal cell. Pharmacokinetics Pharmacokinetic studies in men with radiolabeled ciclopirox solution in polyethylene glycol 400 showed an average of 1.3% absorption of the dose when it was applied topically to 750 cm2 on the back followed by occlusion for 6 hours. The biological half-life was 1.7 hours and excretion occurred via the kidney. Two days after application only 0.01% of the dose applied could be found in the urine. Fecal excretion was negligible. Autoradiographic studies with human cadaver skin showed that ciclopirox penetrates into the hair and through the epidermis and hair follicles into the sebaceous glands and dermis, while a portion of the drug remains in the stratum corneum. In vitro penetration studies in frozen or fresh excised human cadaver and pig skin indicated that the penetration of ciclopirox olamine topical suspension, 1% is equivalent to that of ciclopirox olamine cream, 1%. Therapeutic equivalence of cream and suspension formulations also was indicated by studies of experimentally induced guinea pig and human trichophytosis."],"contraindications":["CONTRAINDICATIONS: Ciclopirox olamine topical suspension, is contraindicated in individuals who have shown hypersensitivity to any of its components."],"description":["DESCRIPTION: Ciclopirox Olamine Topical Suspension, USP 1% is for topical use only. Each gram of Ciclopirox olamine topical suspension, USP 1% contains 10 mg of ciclopirox olamine equivalent to 7.70 mg of ciclopirox in a water miscible lotion base consisting of purified water USP, cocamide DEA, octyldodecanol NF, mineral oil USP, stearyl alcohol NF, cetyl alcohol NF, polysorbate 60 NF, myristyl alcohol NF, sorbitan monostearate NF, lactic acid USP, and benzyl alcohol NF (1%) as a preservative. Ciclopirox olamine topical suspension, USP 1% contains a synthetic, broad spectrum, antifungal agent ciclopirox (as ciclopirox olamine). The chemical name is 6-cyclohexyl-1-hydroxy-4-methyl-2(1 H )-pyridone, 2-aminoethanol salt. The CAS Registry Number is 41621-49-2. Ciclopirox olamine topical suspension, USP 1% has a pH of 7. The chemical structure is: Chemical Structure"],"dosage_and_administration":["DOSAGE AND ADMINISTRATION: Gently massage ciclopirox olamine topical suspension into the affected and surrounding skin areas twice daily, in the morning and evening. Clinical improvement with relief of pruritus and other symptoms usually occurs within the first week of treatment. If a patient shows no clinical improvement after four weeks of treatment with ciclopirox olamine topical suspension the diagnosis should be redetermined. Patients with tinea versicolor usually exhibit clinical and mycological clearing after two weeks of treatment."],"effective_time":"20260902","how_supplied":["HOW SUPPLIED: Ciclopirox olamine topical suspension, USP 1% is supplied in: 30 mL bottles ( NDC 0168-0314-30) 60 mL bottles ( NDC 0168-0314-60) Bottle space provided to allow for vigorous shaking before each use. Store between 5°C to 25°C (41°F to 77°F). E. FOUGERA & CO . A division of Fougera PHARMACEUTICAL INC. Melville, New York 11747 Revised: 01/2026"],"id":"1120d996-3371-4f36-97ea-586953282896","indications_and_usage":["INDICATIONS AND USAGE: Ciclopirox olamine topical suspension, 1% is indicated for the topical treatment of the following dermal infections: tinea pedis, tinea cruris, and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum , and Microsporum canis ; cutaneous candidiasis (moniliasis) due to Candida albicans ; and tinea (pityriasis) versicolor due to Malassezia furfur ."],"information_for_patients":["Information for Patients The patient should be told to: 1. Use the medication for the full treatment time even though signs/symptoms may have improved and notify the physician if there is no improvement after four weeks. 2. Inform the physician if the area of application shows signs of increased irritation (redness, itching, burning, blistering, swelling, oozing) indicative of possible sensitization. 3. Avoid the use of occlusive wrappings or dressings."],"nursing_mothers":["Nursing Mothers It is not known whether this drug is excreted in human milk. Caution should be exercised when ciclopirox olamine topical suspension is administered to a nursing woman."],"openfda":{},"package_label_principal_display_panel":["PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 30 ML CONTAINER NDC 0168-0314-30 Fougera ® CICLOPIROX TOPICAL SUSPENSION USP 0.77% (w/w) (LOTION) Rx Only FOR DERMATOLOGIC USE ONLY NOT FOR OPHTHALMIC USE Keep out of reach of children. Bottle space provided to allow for vigorous shaking before each use. 30 mL 30 ML CONTAINER","PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 30 ML CARTON NDC 0168-0314-30 Fougera ® CICLOPIROX TOPICAL SUSPENSION, USP 0.77% (w/w) (LOTION) Rx Only FOR DERMATOLOGIC USE ONLY NOT FOR OPHTHALMIC USE Keep out of reach of children. Bottle space provided to allow for vigorous shaking before each use. 30 mL 30 ML CARTON"],"pediatric_use":["Pediatric Use Safety and effectiveness in pediatric patients below the age of 10 years have not been established."],"precautions":["PRECAUTIONS: If a reaction suggesting sensitivity or chemical irritation should occur with the use of ciclopirox olamine topical suspension, 1%, treatment should be discontinued and appropriate therapy instituted. Information for Patients The patient should be told to: 1. Use the medication for the full treatment time even though signs/symptoms may have improved and notify the physician if there is no improvement after four weeks. 2. Inform the physician if the area of application shows signs of increased irritation (redness, itching, burning, blistering, swelling, oozing) indicative of possible sensitization. 3. Avoid the use of occlusive wrappings or dressings. Carcinogenesis, Mutagenesis, Impairment of Fertility A 104-week dermal carcinogenicity study in mice was conducted with ciclopirox cream applied at doses up to 1.93% (100 mg/kg/day or 300 mg/m 2 /day). No increase in drug related neoplasms was noted when compared to control. The following in vitro genotoxicity tests have been conducted with ciclopirox: evaluation of gene mutation in the Ames Salmonella and E. coli assays (negative); chromosome aberration assays in V79 Chinese hamster lung fibroblast cells, with and without metabolic activation (positive); chromosome aberration assays in V79 Chinese hamster lung fibroblast cells in the presence of supplemental Fe 3+ , with and without metabolic activation (negative); gene mutation assays in the HGPRT-test with V79 Chinese hamster lung fibroblast cells (negative); and a primary DNA damage assay (i.e., unscheduled DNA synthesis assay in A549 human cells) (negative). An in vitro cell transformation assay in BALB/c 3T3 cells was negative for cell transformation. In an in vitro Chinese hamster bone marrow cytogenetic assay, ciclopirox was negative for chromosome aberrations at a dosage of 5000 mg/kg body weight. A combined oral fertility and embryofetal developmental study was conducted in rats with ciclopirox olamine. No effect on fertility or reproductive performance was noted at the highest dose tested of 3.85 mg/kg/day ciclopirox (approximately 1.2 times the maximum recommended human dose based on body surface area comparisons). Pregnancy Teratogenic Effects: Pregnancy Category B. There are no adequate or well-controlled studies in pregnant women. Therefore, ciclopirox olamine topical suspension should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Oral embryofetal developmental studies were conducted in mice, rats, rabbits and monkeys. Ciclopirox or ciclopirox olamine was orally administered during the period of organogenesis. No maternal toxicity, embryotoxicity or teratogenicity were noted at the highest doses of 77, 125, 80 and 38.5 mg/kg/day ciclopirox in mice, rats, rabbits and monkeys, respectively (approximately 11, 37, 51 and 24 times the maximum recommended human dose based on body surface area comparisons, respectively). Dermal embryofetal developmental studies were conducted in rats and rabbits with ciclopirox olamine dissolved in PEG 400. Ciclopirox olamine was topically administered during the period of organogenesis. No maternal toxicity, embryotoxicity or teratogenicity were noted at the highest doses of 92 mg/kg/day and 77 mg/kg/day ciclopirox in rats and rabbits, respectively (approximately 27 and 49 times the maximum recommended human dose based on body surface area comparisons, respectively). Nursing Mothers It is not known whether this drug is excreted in human milk. Caution should be exercised when ciclopirox olamine topical suspension is administered to a nursing woman. Pediatric Use Safety and effectiveness in pediatric patients below the age of 10 years have not been established."],"pregnancy":["Pregnancy Teratogenic Effects: Pregnancy Category B. There are no adequate or well-controlled studies in pregnant women. Therefore, ciclopirox olamine topical suspension should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Oral embryofetal developmental studies were conducted in mice, rats, rabbits and monkeys. Ciclopirox or ciclopirox olamine was orally administered during the period of organogenesis. No maternal toxicity, embryotoxicity or teratogenicity were noted at the highest doses of 77, 125, 80 and 38.5 mg/kg/day ciclopirox in mice, rats, rabbits and monkeys, respectively (approximately 11, 37, 51 and 24 times the maximum recommended human dose based on body surface area comparisons, respectively). Dermal embryofetal developmental studies were conducted in rats and rabbits with ciclopirox olamine dissolved in PEG 400. Ciclopirox olamine was topically administered during the period of organogenesis. No maternal toxicity, embryotoxicity or teratogenicity were noted at the highest doses of 92 mg/kg/day and 77 mg/kg/day ciclopirox in rats and rabbits, respectively (approximately 27 and 49 times the maximum recommended human dose based on body surface area comparisons, respectively)."],"set_id":"4aeae21c-8c03-4fa9-a191-6b1e9000cbdb","spl_product_data_elements":["Ciclopirox ciclopirox CICLOPIROX OLAMINE CICLOPIROX WATER COCO DIETHANOLAMIDE OCTYLDODECANOL MINERAL OIL STEARYL ALCOHOL CETYL ALCOHOL POLYSORBATE 60 MYRISTYL ALCOHOL SORBITAN MONOSTEARATE LACTIC ACID, UNSPECIFIED FORM BENZYL ALCOHOL"],"spl_unclassified_section":["For Topical Use Only Not for use in eyes Rx Only"],"version":"5","warnings":["WARNINGS: General Ciclopirox olamine topical suspension, 1% is not for ophthalmic use. Keep out of reach of children."]}