Ciclopirox 1 g/100mL Shampoo, 120 mL
🆔 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
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- Do I need to remove the nail lacquer every night before I apply a new coat?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Ciclopirox — tap one for details:
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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.
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UNII D6DH1DTN7E
Disodium laureth sulfosuccinate is a synthetic surfactant and emulsifier derived from lauryl alcohol. It helps mix oil and water-based ingredients together and is commonly used in topical formulations to improve product texture and spreadability.
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UNII D4D38LT1L5
A synthetic ingredient made from lauryl alcohol and ethylene oxide. It works as an emulsifier and surfactant to help mix water and oil-based ingredients together in the medicine.
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UNII 451W47IQ8X
Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
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UNII BPV390UAP0
Sodium laureth sulfate is a mild detergent and surfactant derived from coconut oil or petroleum. It helps mix oil and water in formulations and is often used as a cleaning or foaming agent in topical products like shampoos and cleansers.
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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.
5 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
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💲 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 mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.228 | $27.31 / 120 ml |
| Medicaid paysCMS SDUD · 12 mo | $0.3089 | $37.07 / 120 ml |
| Medicare drug plans payPart D · Q2 2026 | $0.3424 | $41.09 / 120 ml |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Ciclopirox 10 mg/.96mL 00591-2159-90 | Actavis | 120 ml | $0.228 | AT | Availability likely | — |
| Ciclopirox 1 g/100mL 21922-0105-52 | Encube | 1 bottle | $0.228 | AT | Availability likely | — |
| Ciclopirox 1 g/100mLthis 45802-0401-09 | Padagis | 120 ml | $0.228 | AT | Availability likely | — |
| Ciclopirox 10 mg/.96mL 51672-1351-08 | Sun | 1 bottle | $0.228 | AT | Availability likely | — |
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
📊 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 | Marketing start | Status |
|---|---|---|---|
| 45802-0401-09 You're viewing this | 120 mL in 1 BOTTLE (45802-401-09) | 2010-02-17 | Active |
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Ciclopirox Shampoo, 1% is indicated for the topical treatment of seborrheic dermatitis of the scalp in adults. • Ciclopirox Shampoo, 1% is an antifungal indicated for the topical treatment of seborrheic dermatitis of the scalp in adults. ( 1 )
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Ciclopirox Shampoo, 1% is not for ophthalmic, oral, or intravaginal use. Wet hair and apply approximately 1 teaspoon (5 mL) of Ciclopirox Shampoo, 1% to the scalp. Up to 2 teaspoons (10 mL) may be used for long hair.
Lather and leave on hair and scalp for 3 minutes. A timer may be used. Avoid contact with eyes.
Rinse off. Treatment should be repeated twice per week for 4 weeks, with a minimum of 3 days between applications. If a patient with seborrheic dermatitis shows no clinical improvement after 4 weeks of treatment with Ciclopirox Shampoo, 1%, the diagnosis should be reviewed. • Apply approximately 1 teaspoon of Ciclopirox Shampoo, 1% to the scalp twice per week for 4 weeks.
( 2 ) • For topical use only. Not for ophthalmic, oral, or intravaginal use. ( 2 )
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Ciclopirox Shampoo, 1% is a shampoo containing 1% ciclopirox. Each gram (equivalent to 0.96 mL) of Ciclopirox Shampoo, 1% contains 10 mg ciclopirox in a colorless and translucent shampoo base. • Shampoo, 1% ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS None. None ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS • If signs of irritation occur, discontinue use. ( 5.1 ) • Avoid contact with eyes. ( 5.1 ) • Hair discoloration has been reported with Ciclopirox Shampoo, 1% use. ( 5.1 )
5.1Local Effects If a reaction suggesting sensitivity or irritation occurs with the use of Ciclopirox Shampoo, 1%, treatment should be discontinued and appropriate therapy instituted. Contact of Ciclopirox Shampoo, 1% with the eyes should be avoided. If contact occurs, rinse thoroughly with water. In patients with lighter hair color, hair discoloration has been reported.
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS • The most frequently reported adverse reactions are pruritus, burning, and erythema. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Padagis at 1-866-634-9120 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. In 626 subjects treated with ciclopirox shampoo, 1% twice weekly in the two pivotal clinical trials, the most frequent adverse events were increased itching in 1% of subjects, and application site reactions, such as burning, erythema, and itching, also in 1% of subjects.
6.2Post Marketing Experience The following adverse reactions have been identified during post approval use of Ciclopirox Shampoo, 1%: hair discoloration and abnormal hair texture, alopecia, irritation and rash. Because these events are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Teratogenic Effects: Pregnancy Category B There are no adequate or well-controlled studies in pregnant women. Therefore, Ciclopirox Shampoo, 1% 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 13, 42, 54 and 26 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 31 and 54 times the maximum recommended human dose based on body surface area comparisons, respectively).
8.3Nursing 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 Ciclopirox Shampoo, 1% is administered to a nursing woman.
8.4Pediatric Use No clinical trials have been conducted in subjects younger than 16 years.
8.5Geriatric Use In clinical trials, the safety and tolerability of ciclopirox shampoo, 1% in the population 65 years and older was comparable to that of younger subjects. Results of the efficacy analysis in those subjects 65 years and older showed effectiveness in 25 of 85 (29%) subjects treated with ciclopirox shampoo, 1%, and in 15 of 61 (25%) subjects treated with the vehicle; due to the small sample size, a statistically significant difference was not demonstrated. Other reported clinical experience has not identified differences in responses between the elderly and younger subjects, but greater sensitivity to adverse effects in some older individuals cannot be ruled out.
🤰 Pregnancy ▾
8.1Pregnancy Teratogenic Effects: Pregnancy Category B There are no adequate or well-controlled studies in pregnant women. Therefore, Ciclopirox Shampoo, 1% 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 13, 42, 54 and 26 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 31 and 54 times the maximum recommended human dose based on body surface area comparisons, respectively).
🧒 Pediatric Use ▾
8.4Pediatric Use No clinical trials have been conducted in subjects younger than 16 years.
🧓 Geriatric Use ▾
8.5Geriatric Use In clinical trials, the safety and tolerability of ciclopirox shampoo, 1% in the population 65 years and older was comparable to that of younger subjects. Results of the efficacy analysis in those subjects 65 years and older showed effectiveness in 25 of 85 (29%) subjects treated with ciclopirox shampoo, 1%, and in 15 of 61 (25%) subjects treated with the vehicle; due to the small sample size, a statistically significant difference was not demonstrated. Other reported clinical experience has not identified differences in responses between the elderly and younger subjects, but greater sensitivity to adverse effects in some older individuals cannot be ruled out.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Ciclopirox is a hydroxypyridone antifungal agent although the relevance of this property for the indication of seborrheic dermatitis is not known. Ciclopirox 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.
12.2Pharmacodynamics The pharmacodynamics of Ciclopirox Shampoo, 1% are unknown.
12.3Pharmacokinetics In a study in patients with seborrheic dermatitis of the scalp, application of 5 mL ciclopirox shampoo 1% twice weekly for 4 weeks, with an exposure time of 3 minutes per application, resulted in detectable serum concentrations of ciclopirox in 6 out of 18 patients. The serum concentrations measured throughout the dosing interval on Days 1 and 29 ranged from 10.3 ng/mL to 13.2 ng/mL. Total urinary excretion of ciclopirox was less than 0.5% of the administered dose.
12.4Microbiology Ciclopirox is fungicidal in vitro against Malassezia furfur (Pityrosporum spp.), P. ovale , and P. orbiculare . The clinical significance of antifungal activity in the treatment of seborrheic dermatitis is not known.
🧬 Mechanism of Action ▾
12.1Mechanism of Action Ciclopirox is a hydroxypyridone antifungal agent although the relevance of this property for the indication of seborrheic dermatitis is not known. Ciclopirox 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 ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Ciclopirox Shampoo, 1% is colorless and translucent, and supplied in 120 mL plastic bottles (NDC 45802- 401 -09). Discard unused product after initial treatment duration. Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature]. Keep out of reach of children.
📋 Description ▾
11 DESCRIPTION Ciclopirox Shampoo, 1% contains the synthetic antifungal agent, ciclopirox for topical use. Each gram (equivalent to 0.96 mL) of Ciclopirox Shampoo, 1% contains 10 mg ciclopirox in a shampoo base consisting of disodium laureth sulfosuccinate, laureth-2, purified water, sodium chloride, and sodium laureth sulfate. Ciclopirox Shampoo, 1% is a colorless, translucent solution.
The chemical name for ciclopirox is 6-cyclohexyl-1-hydroxy-4-methyl-2(1 H )-pyridone, with the empirical formula C 12 H 17 NO 2 and a molecular weight of 207.27. The CAS Registry Number is [29342-05-0]. The chemical structure is: chemical structure image
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION See FDA-approved patient labeling (Patient Information). The patient should be instructed to: • Use Ciclopirox Shampoo, 1% as directed by the physician. Avoid contact with the eyes.
If contact occurs, rinse thoroughly with water. Ciclopirox Shampoo, 1% is for external use on the scalp only. Do not swallow. • Use Ciclopirox Shampoo, 1% for seborrheic dermatitis for the full treatment time even though symptoms may have improved.
Notify the physician if there is no improvement after 4 weeks. • Inform the physician if the area of application shows signs of increased irritation (redness, itching, burning, blistering, swelling, or oozing).