Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Clotrimazole Cream USP, 1% is supplied in 15 g (NDC 51672-1275-1), 30 g (NDC 51672-1275-2), 45 g (NDC 51672-1275-6) and (2 × 45) g (NDC 51672-1275-7) tubes. Store at 20˚-25˚C (68˚-77˚F) [see USP Controlled Room Temperature].; PRINCIPAL DISPLAY PANEL - Tube Carton Clotrimazole Cream USP, 1% FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. Rx only Keep this and all medications out of the reach of children. Principal Display Panel - 2 x 45 g Tube Carton SUN label
- HOW SUPPLIED Clotrimazole Cream USP, 1% is supplied in 15 g (NDC 51672-1275-1), 30 g (NDC 51672-1275-2), 45 g (NDC 51672-1275-6) and (2 × 45) g (NDC 51672-1275-7) tubes. Store at 20˚-25˚C (68˚-77˚F) [see USP Controlled Room Temperature].
- PRINCIPAL DISPLAY PANEL - Tube Carton Clotrimazole Cream USP, 1% FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. Rx only Keep this and all medications out of the reach of children. Principal Display Panel - 2 x 45 g Tube Carton SUN label
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 USP contains 10 mg clotrimazole, dispersed in a vanishing cream base of cetostearyl alcohol, cetyl esters wax, 2-octyldodecanol, polysorbate 60, purified water, sorbitan monostearate, and benzyl alcohol (1%) as preservative. Chemical Structure
Indications & Usage
Clotrimazole cream USP 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 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 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 USP is not for ophthalmic use.
Contraindications
Clotrimazole cream USP 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. To report SUSPECTED ADVERSE REACTIONS, contact Sun Pharmaceutical Industries, Inc. at 1-866-923-4914 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˚-25˚C (68˚-77˚F) [see USP Controlled Room Temperature].
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