Ciclopirox
7.7 mg/g · Gel
- Prescription only
- Active substance
- Ciclopirox
- Made by
- Glenmark Pharmaceuticals Inc., USA
- Source
- Official label
Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.
At a glance
Quoted from the official label · 2026-01-23
- Superficial Dermatophyte Infections Ciclopirox gel is indicated for the topical treatment of interdigital tinea pedis and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes, or…
Ciclopirox gel is contraindicated in individuals who have shown hypersensitivity to any of its components.
All warnings ↓- Prescription only
- FDA enforcement reports list no ongoing recall, and none from the last two years, for this product code · checked 2026-10-02
Every line above is selected, not written, from the official label. Nothing is reworded. DailyMed
What it is for
- Superficial Dermatophyte Infections Ciclopirox gel is indicated for the topical treatment of interdigital tinea pedis and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes, or Epidermophyton floccosum .
- Seborrheic Dermatitis Ciclopirox gel is indicated for the topical treatment of seborrheic dermatitis of the scalp.
From the official label · 2026-01-23 · DailyMed
How it works
From this product’s own US prescribing label.
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.
Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2026-01-23
Do not take it if
Ciclopirox gel is contraindicated in individuals who have shown hypersensitivity to any of its components.
Quoted from the official label, section “Contraindications”.
How to take it
These directions are for this exact strength and form. Another one is different.
- Superficial Dermatophyte Infections Gently massage ciclopirox gel into the affected areas and surrounding skin twice daily, in the morning and evening immediately after cleaning or washing the areas to be treated.
- Interdigital tinea pedis and tinea corporis should be treated for 4 weeks.
- If a patient shows no clinical improvement after 4 weeks of treatment, the diagnosis should be reviewed.
- Seborrheic Dermatitis of the Scalp Apply ciclopirox gel to affected scalp areas twice daily, in the morning and evening for 4 weeks.
- Clinical improvement usually occurs within the first week with continuing resolution of signs and symptoms through the fourth week of treatment.
- If a patient shows no clinical improvement after 4 weeks of treatment, the diagnosis should be reviewed.
Quoted from the official label, section “Dosage & Administration”.
Other warnings
- Ciclopirox gel is not for ophthalmic, oral, or intravaginal use.
- Keep out of reach of children.
- If a reaction suggesting sensitivity or chemical irritation should occur with the use of ciclopirox gel, treatment should be discontinued and appropriate therapy instituted.
- A transient burning sensation may occur, especially after application to sensitive areas.
- Avoid contact with eyes.
- Efficacy of ciclopirox gel in immunosuppressed individuals has not been studied.
- Seborrheic dermatitis in association with acne, atopic dermatitis, Parkinsonism, psoriasis and rosacea has not been studied with ciclopirox gel.
- Efficacy in the treatment of plantar and vesicular types of tinea pedis has not been established.
- Information for Patients The patient should be told the following: 1.
- Carcinogenesis, Mutagenesis, Impairment of Fertility A 104-week dermal carcinogenicity study in mice was conducted with ciclopirox cream formulation applied at doses up to 1.93% (100 mg/kg/day or 300 mg/m 2 /day).
- No increase in drug related neopalsms 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 vivo Chinese hamster bone marrow cytogenetic assay, ciclopirox was negative for chromosome aberrations at a dosage of 5,000 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:
- Nursing Mothers It is not known whether this drug is excreted in human milk.
- Pediatric Use The efficacy and safety of ciclopirox gel in pediatric patients below the age of 16 years have not been established.
Quoted from the official label, section “Warnings”.
Pregnancy and breastfeeding
- Teratogenic effects:
- Pregnancy Category B There are no adequate or well-controlled studies in pregnant women.
- Therefore, ciclopirox gel 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).
- It is not known whether this drug is excreted in human milk. Since many drugs are excreted in human milk, caution should be exercised when ciclopirox gel is administered to a nursing woman.
Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.
Use in children
The efficacy and safety of ciclopirox gel in pediatric patients below the age of 16 years have not been established.
Quoted from the official label, section “Pediatric Use”.
Side effects
- In clinical trials, 140 (39%) of 359 subjects treated with ciclopirox gel reported adverse experiences, irrespective of relationship to test materials, which resulted in 8 subjects discontinuing treatment.
- The most frequent experience reported was skin burning sensation upon application, which occurred in approximately 34% of seborrheic dermatitis patients and 7% of tinea pedis patients.
- Adverse experiences occurring between 1% to 5% were contact dermatitis and pruritus.
- Other reactions that occurred in less than 1% included dry skin, acne, rash, alopecia, pain upon application, eye pain, and facial edema.
Quoted from the official label, section “Adverse Reactions”.
What to discuss with your doctor
- The patient should be told the following: 1.
- Use ciclopirox gel as directed by the physician.
- Avoid contact with the eyes and mucous membranes.
- Ciclopirox gel is for external use only. 2.
- Use the medication for fungal infections for the full treatment time even though symptoms may have improved, and notify the physician if there is no improvement after 4 weeks. 3.
- A transient burning/stinging sensation may be felt.
- This may occur in approximately 15% to 20% of cases, when ciclopirox gel is used to treat seborrheic dermatitis of the scalp. 4.
- Inform the physician if the area of application shows signs of increased irritation or possible sensitization (redness with itching, burning, blistering, swelling, and/or oozing). 5.
- Avoid the use of occlusive dressings. 6.
- Do not use this medication for any disorder other than that for which it is prescribed.
Quoted from the official label, section “Patient Counseling Information”.
What it looks like and how it is packed
- Ciclopirox gel 0.77% is supplied in aluminum tubes and LDPE tubes. 30 g tubes (NDC 68462-455-35), 45 g tubes (NDC 68462-455-47) and 100 g tubes (NDC 68462-455-94).
- Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature].
- Distributed by:
- Glenmark Pharmaceuticals Inc., USA Elmwood Park, NJ 07407 Questions? 1 (888)721-7115 www.glenmarkpharma-us.com April 2025 glenmarklogo
Quoted from the official label, section “How Supplied”.
What is in it
- Ciclopirox gel 0.77% contains a synthetic antifungal agent, ciclopirox USP.
- It is intended for topical dermatologic use only.
- Each gram of ciclopirox gel contains 7.70 mg of ciclopirox USP in a gel consisting of carbomer 940, isopropyl alcohol, and medium chain triglycerides, sodium hydroxide, sodium lauryl sulfate, and purified water.
- Ciclopirox gel is a white, slightly fluid gel.
- The chemical name for ciclopirox USP is 6-cyclohexyl-1-hydroxy-4-methyl-2(1 H )-pyridinone, 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: structure
Quoted from the official label, section “Description”.
Ingredients people check for
Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.
The stored label for this product has no list of inactive ingredients. The list on the pack is the one to check.
Quoted from the FDA label. A label that does not name an ingredient is not a guarantee that the product is free of it, and formulations change. With an allergy, check the pack and ask a pharmacist.
Every version of this medicine (3)
The same active substance, strength and kind of form, from every company that sells it — with what each label lists.
Showing 3 of 3
Same active substance, strength and form in other countries
Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.
Medicine passport: one printable page to show a pharmacist abroad
SpainNo exact match for this strength and form
FranceNo exact match for this strength and form
CanadaNo exact match for this strength and form
Details
| Made by | Glenmark Pharmaceuticals Inc., USA |
|---|---|
| Active substance | Ciclopirox |
| Strength | 7.7 mg/g |
| Form | Gel |
| Route | Topical |
| Packs | 30 g in 1 TUBE · 45 g in 1 TUBE |
| NDC | 68462-455 |
Source: NDC Directory · 2026-09-13 · not reviewed by a clinician
Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).
Other strengths and forms
16 products are sold under this name. Grouped by form; a number on a strength means several companies make it.
- Solution8 products
- Shampoo4 products
1 g/100mL2
1 g/100mL · 2 companies
10 mg/.96mL2
10 mg/.96mL · 2 companies
- Gel3 products
7.7 mg/g3
7.7 mg/g · 3 companies
- Bryant Ranch Prepack
- Glenmark Pharmaceuticals Inc., USA · this page
- Padagis US LLC
- Kit1 products
Same active substance
These contain the same substance. That does not mean one can replace another — ask a pharmacist.