Drug Facts
Composition & Profile
Identifiers & Packaging
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 NDC 50228-502-61 in two 30 mL round bottles in a carton Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].; PRINCIPAL DISPLAY PANEL - 10 mL Container label NDC 50228-502-08 Clotrimazole Topical Solution, USP 1% FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. 10 mL Rx Only ScieGen Pharmaceuticals Inc. PRINCIPAL DISPLAY PANEL - 30 mL Oval Container label NDC 50228-502-30 Clotrimazole Topical Solution, USP 1% FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. 30 mL Rx Only ScieGen Pharmaceuticals Inc. PRINCIPAL DISPLAY PANEL - 30 mL Round Container label NDC 50228-502-31 Clotrimazole Topical Solution, USP 1% FOR EXTERNAL USE ONLY. NOT FOR OPTHALMIC USE. Keep this and all medications out of reach of children. 30 mL Rx Only ScieGen Pharmaceuticals Inc. PRINCIPAL DISPLAY PANEL - 10 mL Carton label NDC 50228- 502 -08 Clotrimazole Topical Solution, USP 1% FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. Keep this and all medications out of the reach of children. 10 mL Rx Only ScieGen Pharmaceuticals Inc. PRINCIPAL DISPLAY PANEL - 30 mL Carton label NDC 50228- 502 -30 Clotrimazole Topical Solution, USP 1% FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. Keep this and all medications out of the reach of children. 30 mL Rx Only ScieGen Pharmaceuticals Inc. PRINCIPAL DISPLAY PANEL - 30 mL Carton label NDC 50228-502-31 Clotrimazole Topical Solution, USP 1% FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. Keep this and all medications out of the reach of children. 30 mL Rx Only ScieGen Pharmaceuticals Inc. PRINCIPAL DISPLAY PANEL - 2 x 30 mL Carton label NDC 50228- 502 -61 Clotrimazole Topical Solution, USP 1% FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. Keep this and all medications out of the reach of children. 2 x 30 mL Rx Only ScieGen Pharmaceuticals Inc. clotrimazole clotrimazole clotrimazole clotrimazole clotrimazole clotrimazole clotrimazole
- 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 NDC 50228-502-61 in two 30 mL round bottles in a carton Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
- PRINCIPAL DISPLAY PANEL - 10 mL Container label NDC 50228-502-08 Clotrimazole Topical Solution, USP 1% FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. 10 mL Rx Only ScieGen Pharmaceuticals Inc. PRINCIPAL DISPLAY PANEL - 30 mL Oval Container label NDC 50228-502-30 Clotrimazole Topical Solution, USP 1% FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. 30 mL Rx Only ScieGen Pharmaceuticals Inc. PRINCIPAL DISPLAY PANEL - 30 mL Round Container label NDC 50228-502-31 Clotrimazole Topical Solution, USP 1% FOR EXTERNAL USE ONLY. NOT FOR OPTHALMIC USE. Keep this and all medications out of reach of children. 30 mL Rx Only ScieGen Pharmaceuticals Inc. PRINCIPAL DISPLAY PANEL - 10 mL Carton label NDC 50228- 502 -08 Clotrimazole Topical Solution, USP 1% FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. Keep this and all medications out of the reach of children. 10 mL Rx Only ScieGen Pharmaceuticals Inc. PRINCIPAL DISPLAY PANEL - 30 mL Carton label NDC 50228- 502 -30 Clotrimazole Topical Solution, USP 1% FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. Keep this and all medications out of the reach of children. 30 mL Rx Only ScieGen Pharmaceuticals Inc. PRINCIPAL DISPLAY PANEL - 30 mL Carton label NDC 50228-502-31 Clotrimazole Topical Solution, USP 1% FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. Keep this and all medications out of the reach of children. 30 mL Rx Only ScieGen Pharmaceuticals Inc. PRINCIPAL DISPLAY PANEL - 2 x 30 mL Carton label NDC 50228- 502 -61 Clotrimazole Topical Solution, USP 1% FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. Keep this and all medications out of the reach of children. 2 x 30 mL Rx Only ScieGen Pharmaceuticals Inc. clotrimazole clotrimazole clotrimazole clotrimazole clotrimazole clotrimazole clotrimazole
Overview
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
Indications & 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 .
Dosage & 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.
Warnings & Precautions
WARNINGS Clotrimazole Topical Solution is not for ophthalmic use.
Contraindications
Topical antifungal agents are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.
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 ScieGen Pharmaceuticals, Inc. at 1-855-724-3436 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
Drug Interactions
Synergism or antagonism between clotrimazole and nystatin, or amphotericin B, or flucytosine against strains of C. albicans has not been reported.
Storage & Handling
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
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