Mediclarum
Medicine guide

Ciclopirox Olamine

7.7 mg/g · Cream

  • Prescription only
Active substance
Ciclopirox Olamine
Made by
Glenmark Pharmaceuticals Inc., USA

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 · 2026-01-22

Used for
  • 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…
Do not take it if

Ciclopirox olamine cream is contraindicated in individuals who have shown hypersensitivity to any of its components.

All warnings ↓
Good to know
  • Prescription only
  • FDA enforcement reports list no ongoing recall, and none from the last two years, for this product code · checked 2026-10-02
7other products contain Ciclopirox Olamine — compare makers, forms and strengths

Every line above is selected, not written, from the official label. Nothing is reworded. DailyMed

What it is for

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.

From the official label · 2026-01-22 · DailyMed

How it works

From this product’s own US prescribing label.

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.

Half-life1.7 h
Mostly cleared after≈ 8.5 hfive half-lives — our arithmetic

Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2026-01-22

Do not take it if

Ciclopirox olamine cream 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.

  • 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.

Quoted from the official label, section “Dosage & Administration”.

Other warnings

  • Ciclopirox olamine cream is not for ophthalmic use. Keep out of reach of children.
  • If a reaction suggesting sensitivity or chemical irritation should occur with the use of ciclopirox olamine cream, treatment should be discontinued and appropriate therapy instituted.
  • Information for Patients The patient should be told to: 1.
  • 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 vivo 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:
  • Nursing Mothers It is not known whether this drug is excreted in human milk.
  • Pediatric Use Safety and effectiveness in pediatric patients below the age of 10 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 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).
  • 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 olamine cream is administered to a nursing woman.

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Use in children

Safety and effectiveness in pediatric patients below the age of 10 years have not been established.

Quoted from the official label, section “Pediatric Use”.

Side effects

  • 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.

Quoted from the official label, section “Adverse Reactions”.

What to discuss with your doctor

  • 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.

Quoted from the official label, section “Patient Counseling Information”.

What it looks like and how it is packed

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.

Quoted from the official label, section “How Supplied”.

How to store it

Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature].

Quoted from the official label, section “Storage and Handling”.

What is in it

  • 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

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 (6)

The same active substance, strength and kind of form, from every company that sells it — with what each label lists.

Showing 6 of 6

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

FranceNo exact match for this strength and form

Every strength and form (18)

CanadaNo exact match for this strength and form

Every strength and form (2)

Details

Made byGlenmark Pharmaceuticals Inc., USA
Active substanceCiclopirox Olamine
Strength7.7 mg/g
FormCream
RouteTopical
Packs15 g in 1 CARTON · 30 g in 1 CARTON
NDC68462-297

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).

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Other strengths and forms

8 products are sold under this name. Grouped by form; a number on a strength means several companies make it.

Same active substance

These contain the same substance. That does not mean one can replace another — ask a pharmacist.

Ciclopirox Olamine7.7 mg/gPrescription onlyCream Cosette Pharmaceuticals, Inc. · Ciclopirox OlamineCiclopirox Olamine7.7 mg/gPrescription onlyCream Padagis Israel Pharmaceuticals Ltd · Ciclopirox OlamineCiclopirox Olamine7.7 mg/mLPrescription onlySuspension Padagis Israel Pharmaceuticals Ltd · Ciclopirox OlamineCiclopirox Olamine7.7 mg/gPrescription onlyCream Sun Pharmaceutical Industries, Inc. · Ciclopirox OlamineCiclopirox Olamine7.7 mg/100mLPrescription onlySuspension Bryant Ranch Prepack · Ciclopirox OlamineCiclopirox Olamine7.7 mg/gPrescription onlyCream Bryant Ranch Prepack · Ciclopirox Olamine

See every product with Ciclopirox Olamine