Ciclopirox Olamine 7.7 mg/g Cream, 15 g
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Other antifungals for topical use class.
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
Ciclopirox topical solution is used along with regular nail trimming to treat fungal infections of the fingernails and toenails (an infection that may cause nail discoloration, splitting and pain). Ciclopirox is in a class of medications called antifungals. It works by stopping the growth of nail fungus.
Read the full MedlinePlus article ↗- Fungal nail infections are slow to clear, and Ciclodan nail lacquer is no exception. In clinical studies, treatment lasted up to 48 weeks. Only a small percentage of patients achie...
- How long does it take for the nail lacquer to work?
- No — that's actually one of the most important things to get right. You apply Ciclodan once a day and leave it on. Each new coat goes right on top of the previous one. After seven...
- Do I need to remove the nail lacquer every night before I apply a new coat?
Patient education
Supplement & herbal interactions
Where does this data come from?
Ask a licensed pharmacist directly — free, answered by our team.
🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
-
UNII LKG8494WBH
Benzyl alcohol is a clear liquid used as a preservative and solvent in medicines. It helps prevent bacterial and fungal growth and dissolves other ingredients to create uniform liquid formulations.
-
UNII 936JST6JCN
Cetyl alcohol is a waxy, fatty substance derived from plant or animal sources. It acts as an emulsifier and thickener in medicines, helping blend oil and water components and giving products a smooth, creamy texture.
-
UNII 33X04XA5AT
Lactic acid is a naturally occurring organic acid derived from milk or plant sources. It lowers and maintains pH in formulations, helps preserve the product, and can enhance ingredient stability and absorption.
-
UNII N6K5787QVP
Light mineral oil is a clear, odorless liquid derived from petroleum. In medicines, it acts as a lubricant and emollient to help the product spread smoothly and improve texture.
-
UNII V42034O9PU
A fatty alcohol derived from coconut or palm oil. It serves as an emulsifier and thickener to help blend oil and water in creams or lotions, and improves the product's texture and consistency.
-
UNII 461N1O614Y
A synthetic oily liquid used as an emollient and solvent in medications. It helps dissolve active ingredients and improves how the medicine spreads or absorbs through the skin.
-
UNII CAL22UVI4M
A synthetic emulsifier derived from sorbitol and fatty acids. It helps mix oil and water-based ingredients together and improves the texture and stability of the medicine.
-
UNII NVZ4I0H58X
A waxy substance made from sorbitol and stearic acid. It acts as an emulsifier and stabilizer, helping keep oil and water mixed together and preventing separation in the medicine.
-
UNII 2KR89I4H1Y
Stearyl alcohol is a waxy, fatty substance derived from natural oils or made synthetically. It acts as an emulsifier and thickener in medicines, helping mix ingredients together and give the product the right texture.
-
UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
10 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per g | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.217 | $3.26 / 15 g |
| Medicaid paysCMS SDUD · 12 mo | $0.4038 | $6.06 / 15 g |
| Medicare drug plans payPart D · Q2 2026 | $0.3074 | $4.61 / 15 g |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Ciclopirox olamine 7.7 mg/g 45802-0138-11 | Padagis | 1 tube | $0.173 | AB | Availability likely | save 20% |
| Ciclopirox Olamine 7.7 mg/g 00713-0638-15 | Cosette | 1 tube | $0.217 | AB | Availability likely | — |
| Ciclopirox Olamine 7.7 mg/g 51672-1318-01 | Sun | 1 tube | $0.217 | AB | Availability likely | — |
| Ciclopirox Olamine 7.7 mg/gthis 68462-0297-17 | Glenmark | 15 g | $0.217 | AB | Availability likely | — |
| Ciclopirox Olamine 7.7 mg/g 63629-8624-01 | Bryant | 1 tube | — | AB | FDA listed | — |
| Ciclopirox Olamine 7.7 mg/g 63629-8625-01 | Bryant | 1 tube | — | AB | FDA listed | — |
| Ciclopirox olamine 7.7 mg/g 63629-8626-01 | Bryant | 1 tube | — | AB | FDA listed | — |
| Ciclopirox olamine 7.7 mg/g 71335-2865-01 | Bryant | 1 tube | — | AB | FDA listed | — |
| Ciclopirox Olamine 7.7 mg/g 72162-1397-02 | Bryant | 1 tube | — | AB | FDA listed | — |
| Ciclopirox Olamine 7.7 mg/g 80425-0225-01 | Advanced | 30 g | — | AB | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
🗺️ Medicaid utilization & spend
💊 Medicaid utilization by pack size
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
Where does this data come from?
📦 Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Status |
|---|---|---|---|---|---|
| 68462-0297-17 You're viewing this | 15 g in 1 CARTON (68462-297-17) | $0.2171 / g | $3.26 | 2009-11-13 | Active |
| 68462-0297-35 | 30 g in 1 CARTON (68462-297-35) | $0.1729 / g | $5.19 | 2009-11-13 | Active |
| 68462-0297-92 | 90 g in 1 CARTON (68462-297-92) | $0.1045 / g | $9.40 | 2009-11-13 | Active |
You're viewing the smallest of 3 pack sizes for this product.
Per g, this pack runs about 108% above the cheapest pack (90 g, $0.1045 vs $0.2171 NADAC).
This pack accounts for about 8.4% of this product's recent Medicaid fills; most go to the 90 gs pack. See all packs ↓
Pack size FAQ
What quantity is in NDC 68462-0297-17?
What is the difference between NDC 68462-0297-17 and NDC 68462-0297-35?
What NDC number is used to bill for this package of Ciclopirox Olamine 7.7 mg/g Cream?
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Ciclopirox olamine cream 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 ; candidiasis (moniliasis) due to Candida albicans ; and tinea (pityriasis) versicolor due to Malassezia furfur.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION Gently massage ciclopirox olamine cream 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 cream, the diagnosis should be redetermined.
Patients with tinea versicolor usually exhibit clinical and mycological clearing after two weeks of treatment.
⛔ Contraindications ▾
CONTRAINDICATIONS Ciclopirox olamine cream is contraindicated in individuals who have shown hypersensitivity to any of its components.
⚠️ Warnings ▾
WARNINGS Ciclopirox olamine cream is not for ophthalmic use. Keep out of reach of children.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS In all controlled clinical studies with 514 patients using ciclopirox olamine cream and in 296 patients using the vehicle cream, the incidence of adverse reactions was low. This included pruritus at the site of application in one patient and worsening of the clinical signs and symptoms in another patient using ciclopirox olamine cream and burning in one patient and worsening of the clinical signs and symptoms in another patient using the vehicle cream.
🤰 Pregnancy ▾
Pregnancy Teratogenic Effects: Pregnancy Category B There are no adequate or well-controlled studies in pregnant women. Therefore, ciclopirox cream 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).
🧒 Pediatric Use ▾
Pediatric Use Safety and effectiveness in pediatric patients below the age of 10 years have not been established.
🧬 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 tagged ciclopirox solution in polyethylene glycol 400 showed an average of 1.3% absorption of the dose when it was applied topically to 750 cm 2 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.
Penetration studies in human cadaverous skin from the back, with ciclopirox olamine cream with tagged ciclopirox showed the presence of 0.8 to 1.6% of the dose in the stratum corneum 1.5 to 6 hours after application. The levels in the dermis were still 10 to 15 times above the minimum inhibitory concentrations. Autoradiographic studies with human cadaverous 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.
Draize Human Sensitization Assay, 21-Day Cumulative Irritancy study, Phototoxicity study, and Photo-Draize study conducted in a total of 142 healthy male subjects showed no contact sensitization of the delayed hypersensitivity type, no irritation, no phototoxicity, and no photo-contact sensitization due to ciclopirox olamine cream.
🧬 Mechanism of Action ▾
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.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Ciclopirox olamine cream USP, 0.77% is supplied in 15 grams (NDC 68462-297-17), 30 grams (NDC 68462-297-35) and 90 grams (NDC 68462-297-92) tubes.
📦 Storage and Handling ▾
Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature].
📋 Description ▾
DESCRIPTION Ciclopirox olamine cream, USP, 0.77% is for topical use. Each gram of ciclopirox olamine cream, USP contains 7.70 mg of ciclopirox (as ciclopirox olamine USP) in a water miscible vanishing cream base consisting of benzyl alcohol (1%) as preservative, cetyl alcohol, lactic acid, light mineral oil, myristyl alcohol, octyldodecanol, polysorbate 60, purified water, sorbitan monostearate and stearyl alcohol. Ciclopirox olamine cream, USP contains a synthetic, broad-spectrum, antifungal agent ciclopirox (as ciclopirox olamine USP).
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. The chemical structure is: structure
💬 Information for Patients ▾
Information for Patients The patient should be told to: 1. Use the medication for the full treatment time even though 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, or oozing) indicative of possible sensitization. 3. Avoid the use of occlusive wrappings or dressings.