Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Proficient Rx LP
079196022
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Clotrimazole and Betamethasone Dipropionate
Product Details
Drug Labeling Information
Complete FDA-approved labeling information including indications, dosage, warnings, contraindications, and other essential prescribing details.
INDICATIONS & USAGE SECTION
Highlight: Clotrimazole and betamethasone dipropionate cream contains a combination of clotrimazole, an azole antifungal, and betamethasone dipropionate, a corticosteroid, and is indicated for the topical treatment of symptomatic inflammatory tinea pedis, tinea cruris, and tinea corporis due to Epidermophyton floccosum, Trichophyton mentagrophytes, and Trichophyton rubrum in patients 17 years and older. (1)
1 INDICATIONS AND USAGE
Clotrimazole and betamethasone dipropionate cream is a combination of an azole antifungal and corticosteroid and is indicated for the topical treatment of symptomatic inflammatory tinea pedis, tinea cruris, and tinea corporis due to Epidermophyton floccosum, Trichophyton mentagrophytes, and Trichophyton rubrum in patients 17 years and older.
DOSAGE & ADMINISTRATION SECTION
Highlight: •
Tinea pedis: Apply a thin film to the affected skin areas twice a day for 2 weeks. Do not use longer than 4 weeks. (2)
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Tinea cruris and tinea corporis: Apply a thin film to the affected skin area twice a day for 1 week. Do not use longer than 2 weeks. (2)
•
Do not use with occlusive dressings unless directed by a physician. (2)
•
Not for ophthalmic, oral or intravaginal use. (2)
2 DOSAGE AND ADMINISTRATION
Treatment of tinea corporis or tinea cruris:
•
Apply a thin film of clotrimazole and betamethasone dipropionate cream into the affected skin areas twice a day for one week.
•
Do not use more than 45 grams per week. Do not use with occlusive dressings.
•
If a patient shows no clinical improvement after 1 week of treatment with clotrimazole and betamethasone dipropionate cream, the diagnosis should be reviewed.
•
Do not use longer than 2 weeks.
Treatment of tinea pedis:
•
Gently massage a sufficient amount of clotrimazole and betamethasone dipropionate cream into the affected skin areas twice a day for two weeks.
•
Do not use more than 45 grams per week. Do not use with occlusive dressings.
•
If a patient shows no clinical improvement after 2 weeks of treatment with clotrimazole and betamethasone dipropionate cream, the diagnosis should be reviewed.
•
Do not use longer than 4 weeks.
Clotrimazole and betamethasone dipropionate cream is for topical use only. It is not for oral, ophthalmic, or intravaginal use.
Avoid contact with eyes. Wash hands after each application.
DOSAGE FORMS & STRENGTHS SECTION
Highlight: Cream, 1%/0.05%. (3)
Each gram of Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05% (base) contains 10 mg of clotrimazole, USP and 0.643 mg of betamethasone dipropionate, USP (equivalent to 0.5 mg of betamethasone). (3)
3 DOSAGE FORMS AND STRENGTHS
Cream, 1%/0.05%. Each gram of Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05% (base) contains 10 mg of clotrimazole, USP and 0.643 mg of betamethasone dipropionate, USP (equivalent to 0.5 mg of betamethasone) in a white to off-white, uniform and smooth cream base.
CONTRAINDICATIONS SECTION
Highlight: None. (4)
4 CONTRAINDICATIONS
None.