CLOTRIMAZOLE 10 mg/mL Spray
Other active recalls for Clotrimazole (different manufacturers) — 2 · tap to view
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Azole Antifungal class.
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
Topical clotrimazole is used to treat tinea corporis (ringworm; fungal skin infection that causes a red scaly rash on different parts of the body), tinea cruris (jock itch; fungal infection of the skin in the groin or buttocks), and tinea pedis (athlete's foot; fungal infection of the skin on the feet and between the toes). Clotrimazole is in a class of antifungal medications called imidazoles. It works by stopping the growth of fungi that cause infection.
Read the full MedlinePlus article ↗- It depends on which product you have. The topical creams, solutions, and sprays treat common fungal skin infections — athlete's foot, jock itch, and ringworm. The CLOTIC ear drops...
- What kinds of infections does clotrimazole actually treat?
- You may start to notice some relief within a few days, but it's important to finish the full course. For athlete's foot and ringworm, that means using it every day for 4 weeks. For...
- How long do I need to use it before it starts working?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Clotrimazole — tap one for details:
Where does this data come from?
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 3K9958V90M
A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
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UNII 7V31YC746X
Chloroform is a clear liquid solvent historically used in pharmaceutical formulations to dissolve or extract active ingredients and other substances. It may appear in some older medicines or specialized preparations as a solvent or preservative component.
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UNII B697894SGQ
Polyethylene glycol 400 is a clear, thick liquid made from petroleum-derived polymers. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
3 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
Are inactive ingredients the same for every manufacturer?
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Can inactive ingredients matter?
💲 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 | $0.511 | $30.67 / 60 ml |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Clotrimazole 10 mg/mLthis 82568-0036-06 | AARNA | 2 bottles | $0.511 | AT | Availability likely | — |
| RoyceDerm Tea Tree Oil Antifungal .spray. 1.2 g/120g 85424-0024-01 | RoyceDerm | 120 g | — | — | FDA listed | — |
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?
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
📦 Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Status |
|---|---|---|---|---|---|
| 82568-0036-01 | 1 BOTTLE in 1 CARTON (82568-0036-1) / 10 mL in 1 BOTTLE | — | — | 2023-10-16 | Active |
| 82568-0036-03 | 1 BOTTLE in 1 CARTON (82568-0036-3) / 30 mL in 1 BOTTLE | — | — | 2023-10-16 | Active |
| 82568-0036-06 You're viewing this | 2 BOTTLE in 1 CARTON (82568-0036-6) / 30 mL in 1 BOTTLE | $0.5112 / mL | $30.67 | 2024-03-09 | Active |
Pack size FAQ
What quantity is in NDC 82568-0036-06?
What NDC number is used to bill for this package of CLOTRIMAZOLE 10 mg/mL Spray?
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Prescription Clotrimazole Topical Solution Spray product is indicated for the topical treatment of candidiasis due to Candida albicans and tinea versicolor due to Malassezia furfur . This formulation is also available as a nonprescription product which 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 fluoccosum , and Microsporum canis .
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION Gently spray sufficient Clotrimazole Topical Solution, USP 1% spray into the affected and surrounding skin areas twice a day, in the morning and evening. Clinical improvement, with relief of pruritus, usually occurs within the first week of treatment with Clotrimazole Topical Solution, USP 1% Spray. If the patient shows no clinical improvement after 4 weeks of treatment with Clotrimazole Topical Solution, USP 1% spray the diagnosis should be reviewed.
⛔ Contraindications ▾
CONTRAINDICATIONS Topical antifungal agents are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.
⚠️ Warnings ▾
WARNINGS Clotrimazole Topical Solution Spray is not for ophthalmic use.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS The following adverse reactions have been reported in connection with the use of clotrimazole: erythema, stinging, blistering, peeling, edema, pruritius, urticaria, burning, and general irritation of the skin. To report SUSPECTED ADVERSE REACTIONS, contact AARNA USA INC. 1-877-225-6999. or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
🔄 Drug Interactions ▾
Drug Interactions Synergism or antagonism between clotrimazole and nystatin, or amphotericin B, or flucytosine against strains of C. albicans has not been reported.
🤰 Pregnancy ▾
Usage in Pregnancy 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 mg/kg to 120 mg/kg resulted in embryotoxicity (possibly 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 mg/kg, 180 mg/kg 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.
🧒 Pediatric Use ▾
Pediatric Use Safety and effectiveness in pediatric patients have been established for clotrimazole when used as indicated and in the recommended dosage.
🆘 Overdosage ▾
OVERDOSAGE Acute overdosage with topical application of clotrimazole is unlikely and would not be expected to lead to a life-threatening situation.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY 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. In vitro , clotrimazole exhibits fungistatic and fungicidal activity against isolates of Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, Microsporum canis, and Candida species including Candida albicans .
In general, the in vitro activity of clotrimazole corresponds to that of tolnaftate and griseofulvin against the mycelia of dermatophytes ( Trichophyton, Microsporum, and Epidermophyton), and to that of the polyenes (amphotericin B and nystatin) against budding fungi ( Candida ). Using an in vivo (mouse) and an in vitro (mouse kidney homogenate) testing system, clotrimazole and miconazole were equally effective in preventing the growth of the pseudomycelia and mycelia of Candida albicans . Strains of fungi having a natural resistance to clotrimazole are rare.
Only a single isolate of Candida guilliermondi has been reported to have primary resistance to clotrimazole. No single-step or multiple-step resistance to clotrimazole has developed during successive passages of Candida albicans and Trichophyton mentagrophytes . No appreciable change in sensitivity was detected after successive passages of isolates of C. albicans, C. krusei, or C. pseudotropicalis in liquid or solid media containing clotrimazole.
Also, resistance could not be developed in chemically induced mutant strains of polyene-resistant isolates of C. albicans . Slight, reversible resistance was noted in three isolates of C. albicans tested by one investigator. There is a single report that records the clinical emergence of a C. albicans strain with considerable resistance to flucytosine and miconazole, and with cross-resistance to clotrimazole; the strain remained sensitive to nystatin and amphotericin B.
In studies of the mechanism of action, the minimum fungicidal concentration of clotrimazole caused leakage of intracellular phosphorus compounds into the ambient medium with concomitant breakdown of cellular nucleic acids and accelerated potassium efflux. Both these events began rapidly and extensively after addition of the drug. Clotrimazole appears to be well absorbed in humans following oral administration and is eliminated mainly as inactive metabolites.
Following topical and vaginal administration, however, clotrimazole appears to be minimally absorbed. Six hours after the application of radioactive clotrimazole 1% cream and 1% solution onto intact and acutely inflamed skin, the concentration of clotrimazole varied from 100 mcg/cm 3 , in the stratum corneum to 0.5 mcg/cm 3 to 1 mcg/cm 3 in the stratum reticulare, and 0.1 mcg/cm 3 in the subcutis. No measurable amount of radioactivity (≤ 0.001 mcg/mL) was found in the serum within 48 hours after application under occlusive dressing of 0.5 mL of the solution or 0.8 g of the cream.
Only 0.5% or less of the applied radioactivity was excreted in the urine. Following intravaginal administration of 100 mg 14 C-clotrimazole vaginal tablets to nine adult females, an average peak serum level, corresponding to only 0.03 mcg equivalents/mL of clotrimazole, was reached 1 to 2 days after application. After intravaginal administration of 5 g of 1% 14 C-clotrimazole vaginal cream containing 50 mg active drug, to five subjects (one with candidal colpitis), serum levels corresponding to approximately 0.01 mcg equivalents/mL were reached between 8 and 24 hours after application.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Clotrimazole Topical Solution, USP 1% Spray is supplied as follows: NDC 82568-0036-1 in one 10 mL round bottle in a carton NDC 82568-0036-3 in one 30 mL round bottle in a carton NDC 82568-0036-6 in two 30 mL round bottles in a carton Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
📦 Storage and Handling ▾
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
📋 Description ▾
DESCRIPTION Clotrimazole Topical Solution USP, 1% Spray contains 10 mg clotrimazole USP, a synthetic antifungal agent having the chemical name 1-(o-Chloro-α,α-diphenylbenzyl) imidazole with the following structural formula: Molecular Formula C 22 H 17 ClN 2 Molecular Weight 344.85 Clotrimazole 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 mL of Clotrimazole Topical Solution, USP 1% Spray contains 10 mg clotrimazole USP in a nonaqueous vehicle of polyethylene glycol 400.
Chemical Structure
💬 Information for Patients ▾
Information for Patient This information is intended to aid in the safe and effective use of this medication. It is not a disclosure of all possible adverse or intended effects. The patient should be advised to: Use the medication for the full treatment time even though the symptoms may have improved.
Notify the physician if there is no improvement after 4 weeks of treatment. Inform the physician if the area of application shows signs of increased irritation (redness, itching, burning, blistering, swelling, oozing) indicative of possible sensitization. Avoid sources of infection or reinfection.