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Molecule

Clotrimazole

Azole Antifungal
Available on requestOrphanDermatology
Presentations
6
Brands
1
Manufacturers
1
Available from stock
0

Clotrimazole is an azole antifungal indicated for the treatment of fungal otitis externa (otomycosis) due to Aspergillus species and Candida species in patients 18 years of age and older. MedsAcross supplies Clotrimazole for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.

Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review

Key facts

Pharmacological class
Azole Antifungal
ATC classification
A01AB18 Clotrimazole · Medications used in dentistry and periodontics, subgroup A01ABD01AC01 Clotrimazole · Antifungals for the skin, subgroup D01A, subgroup D01ACG01AF02 Clotrimazole · Gynaecological anti-infectives, subgroup G01A, subgroup G01AF
US FDA first approval
3 February 1975
EU status
Not recorded
Orphan designation
Yes
WHO essential medicine
Not recorded
India (CDSCO)
Not yet confirmed against CDSCO approval lists
Routes
Topical, Oral, Otic
Dosage forms
Topical solution, Cream, Lozenge, Otic solution, Topical spray
Identifiers
UNII G07GZ97H65RxCUI 2623CAS 23593-75-1DrugBank DB00257Q413546

Clinical information

From the regulator-approved product information. Each section names its source.

Uses

CLOTIC is indicated for the treatment of fungal otitis externa (otomycosis) due to Aspergillus species and Candida species in patients 18 years of age and older. Limitations of Use CLOTIC has only been studied in patients with intact tympanic membranes. The use of CLOTIC is not recommended for the treatment of otomycosis in patients with perforated tympanic membranes. CLOTIC is an azole antifungal indicated for the treatment of fungal otitis externa (otomycosis) due to Aspergillus species and Candida species in patients 18 years of age and older.

Source: US FDA prescribing information

Dosing overview

CLOTIC is for otic use only. Instill the contents of one single-dose CLOTIC vial into the affected ear canal twice daily, morning and evening, preferably 12 hours apart for 14 consecutive days. See full prescribing information for preparation and administration instructions

Source: US FDA prescribing information

Side effects

The most common adverse reactions that occurred in ≥ 1 patient were headache, application site pain, tinnitus, tympanic membrane perforation, and paresthesia.

Source: US FDA prescribing information

Storage

Store at 20°C to 25°C (68°F to 77°F). Brief exposure to 15°C to 30°C (59°F to 86°F) permitted. Store unused vials in the foil pouch to protect from humidity.

Source: US FDA prescribing information

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

All presentations

6 presentations of Clotrimazole, sorted by availability.

MedicineManufacturerRegisterAvailability
Clotrimazole 10 mg/mL topical solutionTopicalGeneric name—US FDAAvailable on request
Clotrimazole 1% creamTopicalGeneric name—US FDAAvailable on request
Clotrimazole 10 mg lozengeOralGeneric name—US FDAAvailable on request
Clotrimazole 10 mg/mL topical sprayTopicalGeneric name—US FDAAvailable on request
Clotrimazole 10 mg lozengeOral, topicalGeneric name—US FDAAvailable on request
CLOTIC (clotrimazole) otic solution 1.7 mg/0.17 mL otic solutionOticCarwin Pharmaceutical AssociatesUS FDAAvailable on request

Brands by market

1 brand names across 1 markets.

Brand names by country

United States

CLOTIC (clotrimazole) otic solution

Manufacturers

Regulatory status

Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.

RegisterStatusSource
US FDAFirst approved 3 February 1975Drugs@FDA
EU (EMA)Not recorded—
India (CDSCO)Not yet confirmed against CDSCO approval lists—
United StatesRegisteredUS FDA (NDC directory, openFDA)Checked 12 November 2026

Conditions

Conditions linked to Clotrimazole in public data. This is not a list of approved uses, see the clinical information.

Cutaneous candidiasis Dermatomycosis Fungal infectious disease Oral candidiasis Vulvovaginal candidiasis

Questions and answers

Is Clotrimazole available for export from India?

Yes, on request. MedsAcross lists 6 presentations of Clotrimazole and sources them for licensed hospitals, importers and physicians against valid import documents.

What brand names does Clotrimazole have?

The catalogue lists 1 brand names for Clotrimazole, including CLOTIC (clotrimazole) otic solution.

Is Clotrimazole approved by the US FDA?

Yes. The US FDA first approved Clotrimazole on 3 February 1975, according to Drugs@FDA.

Does Clotrimazole need cold chain shipping?

No listed presentation of Clotrimazole is recorded as needing a cold chain. Storage conditions are shown on each presentation page.

Which ATC class is Clotrimazole in?

Clotrimazole is classified under ATC code A01AB18 (Clotrimazole).

References

  1. CLOTIC (clotrimazole) otic solution prescribing information (Carwin Pharmaceutical Associates). U.S. National Library of Medicine, DailyMed. Retrieved 3 March 2026

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