Mediclarum
Medicine guide

Clotrimazole

10 mg/g · Cream

  • Prescription only
  • Azole Antifungal
Active substance
Clotrimazole
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 · 2026-01-30

What it is

Azole Antifungal

Used for
  • Clotrimazole cream USP is indicated for the topical treatment of candidiasis due to Candida albicans and tinea versicolor due to Malassezia furfur.
Do not take it if

Clotrimazole cream is contraindicated in individuals sensitive to 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
161other products contain Clotrimazole — compare makers, forms and strengths

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

What it is for

Clotrimazole is also available as a nonprescription item which is indicated for the topical treatment of the following dermal infections:

  • Clotrimazole cream USP is indicated for the topical treatment of candidiasis due to Candida albicans and tinea versicolor due to Malassezia furfur.
  • tinea pedis, tinea cruris, and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes , Epidermophyton floccosum , and Microsporum canis.

From the official label · 2026-01-30 · DailyMed

How it works

From this product’s own US prescribing label.

Clotrimazole is a broad-spectrum antifungal agent that is used for the treatment of dermal infections caused by various species of pathogenic dermatophytes, yeasts, and Malassezia furfur.

The primary action of clotrimazole is against dividing and growing organisms.

How it leaves the body

Only 0.5% or less of the applied radioactivity was excreted in the urine.

Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2026-01-30

Do not take it if

Clotrimazole cream is contraindicated in individuals sensitive to 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 sufficient clotrimazole cream into the affected and surrounding skin areas twice a day, in the morning and evening.
  • Clinical improvement, with relief of pruritis, usually occurs within the first week of treatment with clotrimazole cream.
  • If the patient shows no clinical improvement after four weeks of treatment with clotrimazole cream, the diagnosis should be reviewed.

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

Other warnings

  • Clotrimazole cream is not for ophthalmic use.
  • General:
  • If irritation or sensitivity develops with the use of clotrimazole cream, treatment should be discontinued and appropriate therapy instituted.
  • Information for Patients: The patient should be advised to: 1.
  • Laboratory Tests If there is lack of response to clotrimazole cream, appropriate microbiological studies should be repeated to confirm the diagnosis and rule out other pathogens before instituting another course of antimycotic therapy.
  • Drug Interactions Synergism or antagonism between clotrimazole and nystatin, or amphotericin B, or flucytosine against strains of C. albicans has not been reported.
  • Carcinogenesis, Mutagenesis, Impairment of Fertility An 18-month oral dosing study with clotrimazole in rats has not revealed any carcinogenic effect.
  • In tests for mutagenesis, chromosomes of the spermatophores of Chinese hamsters which had been exposed to clotrimazole were examined for structural changes during the metaphase.
  • Prior to testing, the hamsters had received five oral clotrimazole doses of 100 mg/kg body weight.
  • The results of this study showed that clotrimazole had no mutagenic effect.
  • Nursing Mothers It is not known whether this drug is excreted in human milk, caution should be exercised when clotrimazole is used by a nursing woman.
  • Pediatric Use Safety and effectiveness in children have been established for clotrimazole when used as indicated and in the recommended dosage.
  • General:
  • If irritation or sensitivity develops with the use of clotrimazole cream, treatment should be discontinued and appropriate therapy instituted.

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

  • Usage in Pregnancy:
  • Pregnancy Category B The disposition of 14 C-clotrimazole has been studied in humans and animals.
  • Clotrimazole is very poorly absorbed following dermal application or intravaginal administration to humans.
  • (See CLINICAL PHARMACOLOGY ) In clinical trials, use of vaginally applied clotrimazole in pregnant women in their second and third trimesters has not been associated with ill effects.
  • There are, however, no adequate and well-controlled studies in pregnant women during the first trimester of pregnancy.
  • Studies in pregnant rats with intravaginal doses up to 100 mg/kg have revealed no evidence of harm to the fetus due to clotrimazole.
  • High oral doses of clotrimazole in rats and mice ranging from 50 to 120 mg/kg resulted in embroyotoxicity (possible secondary to maternal toxicity), impairment of mating, decreased litter size and number of viable young and decreased pup survival to weaning.
  • However, clotrimazole was not teratogenic in mice, rabbits and rats at oral doses up to 200, 180 and 100 mg/kg, respectively.
  • Oral absorption in the rat amounts to approximately 90% of the administered dose.
  • Because animal reproduction studies are not always predictive of human response, this drug should be used only if clearly indicated during the first trimester of pregnancy.
  • It is not known whether this drug is excreted in human milk, caution should be exercised when clotrimazole is used by a nursing woman.

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

Other medicines

Synergism or antagonism between clotrimazole and nystatin, or amphotericin B, or flucytosine against strains of C. albicans has not been reported.

Quoted from the official label, section “Drug Interactions”.

If you take too much

In an emergency, call your local emergency number or a poison control centre.

Acute overdosage with topical application of clotrimazole is unlikely and would not be expected to lead to a life-threatening situation.

Quoted from the official label, section “Overdosage”.

Use in children

Safety and effectiveness in children have been established for clotrimazole when used as indicated and in the recommended dosage.

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

Side effects

  • The following adverse reactions have been reported in connection with the use of this product:
  • erythema, stinging, blistering, peeling, edema, pruritis, urticaria, burning, and general irritation of the skin.

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

What to discuss with your doctor

  • The patient should be advised to: 1.
  • Use the medication for the full treatment time even though the symptoms may have improved.
  • Notify the physician if there is no improvement after four weeks of treatment. 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. 4.
  • Avoid sources of infection or reinfection.

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

What it looks like and how it is packed

Clotrimazole cream USP, 1% is supplied in 15, 30, 45 and (2 x 45) gram tubes. NDC 68462-181-17 (15 g) NDC 68462-181-35 (30 g) NDC 68462-181-47 (45 g) NDC 68462-181-48 (2 x 45 g)

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

How to store it

Store between 2°C- 30°C (36°F -86°F).

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

What is in it

  • Clotrimazole cream USP, 1% contains clotrimazole USP, a synthetic antifungal agent having the chemical name {1-(o-Chloro-α, α-diphenylbenzyl)imidazole}; the molecular formula C 22 H 17 ClN 2 ; a molecular weight of 344.84; and the structural formula:
  • Clotrimazole USP is an odorless, white crystalline substance.
  • It is practically insoluble in water, sparingly soluble in ether and very soluble in polyethylene glycol 400, ethanol and chloroform.
  • Each gram of clotrimazole cream USP contains 10 mg clotrimazole USP, dispersed in a vanishing cream base of sorbitan monostearate, polysorbate 60, cetyl esters wax, cetostearyl alcohol, octyldodecanol, purified water, and benzyl alcohol (1%) as preservative. 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 (65)

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

Hide versions whose label lists:

Showing 65 of 65

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 (6)

CanadaNo exact match for this strength and form

Every strength and form (25)

Details

Made byGlenmark Pharmaceuticals Inc., USA
Active substanceClotrimazole
Used inAntibiotics, antivirals and antifungals taken into the body
Strength10 mg/g
FormCream
RouteTopical
Packs15 g in 1 TUBE · 30 g in 1 TUBE
NDC68462-181

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).

Report wrong or outdated information on this page

Other strengths and forms

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

Show all forms · 5 forms

Same active substance

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

Akin Anti-Fungal10 mg/mLWithout prescriptionSolution Southern Sales & Service, Inc. · ClotrimazoleAlevazol10 mg/gWithout prescriptionOintment Capital Pharmaceutical, LLC · ClotrimazoleAntifungal10 mg/gWithout prescriptionCream Encube Ethicals, Inc. · ClotrimazoleAntifungal1 g/100gWithout prescriptionCream Dynarex Corporation · ClotrimazoleAntifungal1 g/100gWithout prescriptionCream VIVE HEALTH LLC · ClotrimazoleAthletes Foot10 mg/gWithout prescriptionCream FRED'S, INC. · Clotrimazole

See every product with Clotrimazole