CLOTRIMAZOLE TOPICAL SOLUTION 1% 30 ML
Generic: Clotrimazole
CLOTRIMAZOLE TOPICAL SOLUTION 1% 30 ML
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Identification
Clotrimazole
Clotrimazole
Sun Pharmaceutical Industries, Inc.
HUMAN PRESCRIPTION DRUG
Administration
SOLUTION
TOPICAL
ANDA074580
Active Ingredients
| Ingredient | Strength |
|---|---|
| CLOTRIMAZOLE | 10 mg/mL |
Pharmacological Class
Data sourced from openFDA / DailyMed. For full prescribing information, consult the drug label.
Wholesale compliance resources
Drug Resources
Clinical Drug Information
Indications & Usage
INDICATIONS AND USAGE 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 .
Warnings
WARNINGS CLOTRIMAZOLE TOPICAL SOLUTION is not for ophthalmic use.
Dosage & Administration
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.
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.
Information for Patients
Information for Patients 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.
Clinical data sourced from openFDA drug labeling. For complete prescribing information, consult the full drug label.