Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Clotrimazole Cream USP 1% is supplied in tubes as: 15 gram NDC 0168-0133-15 30 gram NDC 0168-0133-30 45 gram NDC 0168-0133-46 Store between 2°- 30°C (36°- 86°F). E. FOUGERA & CO. A division of Fougera Pharmaceuticals Inc. MELVILLE, NEW YORK 11747 I2133B R09/11 #130; PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 15 G CONTAINER NDC 0168-0133-15 fougera ® CLOTRIMAZOLE CREAM USP, 1% KEEP OUT OF THE REACH OF CHILDRENn. Rx only FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. NET WT 15 grams tube15g; PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 15 G CARTON NDC 0168-0133-15 fougera ® Rx only CLOTRIMAZOLE CREAM USP, 1% FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. KEEP OUT OF THE REACH OF CHILDREN. NET WT 15 grams carton15g
- HOW SUPPLIED Clotrimazole Cream USP 1% is supplied in tubes as: 15 gram NDC 0168-0133-15 30 gram NDC 0168-0133-30 45 gram NDC 0168-0133-46 Store between 2°- 30°C (36°- 86°F). E. FOUGERA & CO. A division of Fougera Pharmaceuticals Inc. MELVILLE, NEW YORK 11747 I2133B R09/11 #130
- PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 15 G CONTAINER NDC 0168-0133-15 fougera ® CLOTRIMAZOLE CREAM USP, 1% KEEP OUT OF THE REACH OF CHILDRENn. Rx only FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. NET WT 15 grams tube15g
- PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 15 G CARTON NDC 0168-0133-15 fougera ® Rx only CLOTRIMAZOLE CREAM USP, 1% FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. KEEP OUT OF THE REACH OF CHILDREN. NET WT 15 grams carton15g
Overview
Clotrimazole Cream USP 1% contains clotrimazole, a synthetic antifungal agent having the chemical name {1-(o-Chloro-α, α-diphenylbenzyl)imidazole}; the molecular formula C 22 H 17 ClN 2 ; a molecular weight of 344.84; and the structural formula: 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 gram of Clotrimazole cream contains 10 mg clotrimazole, dispersed in a vanishing cream base of sorbitan monostearate, polysorbate 60, cetyl esters wax, cetostearyl alcohol, octyldodecanol, purified water, and benzyl alcohol (1%) as preservative. StructuralFormula
Indications & Usage
Clotrimazole Cream is indicated for the topical treatment of candidiasis due to Candida albicans and tinea versicolor due to Malassezia furfur. Clotrimazole is also available as a nonprescription item 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 floccosum, and Microsporum canis.
Dosage & Administration
Gently massage sufficient clotrimazole cream 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 cream. If the patient shows no clinical improvement after four weeks of treatment with clotrimazole cream, the diagnosis should be reviewed.
Warnings & Precautions
WARNINGS Clotrimazole cream is not for ophthalmic use.
Contraindications
Clotrimazole cream is contraindicated in individuals sensitive to its components.
Adverse Reactions
The following adverse reactions have been reported in connection with the use of this product: erythema, stinging, blistering, peeling, edema, pruritus, urticaria, burning, and general irritation of the skin.
Drug Interactions
Synergism or antagonism between clotrimazole and nystatin, or amphotericin B, or flucytosine against strains of C. albicans has not been reported.
Similar Drugs
Related medications based on brand, generic name, substance, active ingredients.