Clotrimazole Topical Solution USP, 1%
Solution · Topical
Uses
Prescription Clotrimazole Topical Solution 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
Gently massage sufficient Clotrimazole Topical Solution, USP 1% 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%. If the patient shows no clinical improvement after 4 weeks of treatment with Clotrimazole Topical Solution, USP 1% the diagnosis should be reviewed.
Contraindications
Topical antifungal agents are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.
Warnings
Clotrimazole Topical Solution is not for ophthalmic use.
Precautions
PRECAUTIONS . General If irritation or sensitivity develops with the use of clotrimazole, treatment should be discontinued and appropriate therapy instituted. 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. Laboratory Tests If there is lack of response to clotrimazole, 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, and 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. 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. Nursing Mothers 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 clotrimazole is used by a nursing woman. Pediatric Use Safety and effectiveness in pediatric patients have been established for clotrimazole when used as indicated and in the recommended dosage.
Side effects
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 ScieGen Pharmaceuticals, Inc. at 1-855-724-3436 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
Acute overdosage with topical application of clotrimazole is unlikely and would not be expected to lead to a life-threatening situation.
Description
Clotrimazole Topical Solution USP, 1% 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% contains 10 mg clotrimazole USP in a nonaqueous vehicle of polyethylene glycol 400. Chemical Structure
How supplied
Clotrimazole Topical Solution, USP 1% is supplied as follows: NDC 50228-502-08 in one 10 mL round bottle in a carton NDC 50228-502-30 in one 30 mL round bottle in a carton NDC 50228-502-31 in one 30 mL oval bottle in a carton Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Storage
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Patient information
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.
Label text from the FDA structured product label by ScieGen Pharmaceuticals, Inc (revised Apr 30, 2026). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Clotrimazole in 5 products
Clotrimazole Topical Solution USP, 1% NDC products (5)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 71399-0666 | Clotrimazole 10 mg/mL Solution | Akron Pharma Inc. | ANDA |
| 71297-030 | Clotrimazole 10 mg/mL Solution | Allegis Holdings, LLC | ANDA |
| 72162-2178 | Clotrimazole 10 mg/mL Solution | Bryant Ranch Prepack | ANDA |
| 50228-502 | Clotrimazole 10 mg/mL Solution | ScieGen Pharmaceuticals, Inc | ANDA |
| 52817-800 | Clotrimazole 10 mg/mL Solution | TruPharma LLC | ANDA |
Frequently asked questions
What is Clotrimazole Topical Solution USP, 1% used for?
Prescription Clotrimazole Topical Solution 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,…
What are the side effects of Clotrimazole Topical Solution USP, 1%?
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 ScieGen Pharmaceuticals, Inc. at 1-855-724-3436 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . See the full label for the complete list.
Who makes Clotrimazole Topical Solution USP, 1%?
Clotrimazole Topical Solution USP, 1% is listed by 5 labelers in the FDA NDC directory, including Akron Pharma Inc., Allegis Holdings, LLC, Bryant Ranch Prepack, ScieGen Pharmaceuticals, Inc.