Application Nr Approved Date Route Status External Links
ANDA075673 2001-05-29 Topical RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Clotrimazole And Betamethasone Dipropionate Cream And Lotion Are Indicated In Patients 17 Years And Older For The Topical Treatment Of Symptomatic Inflammatory Tinea Pedis, Tinea Cruris, And Tinea Corporis Due To Epidermophyton Floccosum, Trichophyton Mentagrophytes And Trichophyton Rubrum. Effective Treatment Without The Risks Associated With Topical Corticosteroid Use May Be Obtained Using A Topical Antifungal Agent That Does Not Contain A Corticosteroid, Especially For Noninflammatory Tinea Infections. The Efficacy Of Clotrimazole And Betamethasone Dipropionate Cream Or Lotion For The Treatment Of Infections Caused By Zoophilic Dermatophytes (e.g. Microsporum Canis) Has Not Been Established. Several Cases Of Treatment Failure Of Clotrimazole And Betamethasone Dipropionate Cream, Usp In The Treatment Of Infections Caused By Microsporum Canis Have Been Reported.

All Formulated Excipients (8 Total)

Name Structure Kind Function Status
1. Cetostearyl Alcohol CETOSTEARYL ALCOHOL Unresolved
2. Mineral Oil MINERAL OIL Unresolved
3. Phosphoric Acid PHOSPHORIC ACID Molecular MISC-Miscellaneous , SANI-Sanitizing agent REG-Food additives for which a petition has been filed and a regulation issued.
4. Propylene Glycol PROPYLENE GLYCOL Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
5. Water WATER Molecular
6. Sodium Phosphate, Monobasic, Anhydrous SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS Molecular
7. Cetyl Alcohol CETYL ALCOHOL Molecular
8. Stearyl Alcohol STEARYL ALCOHOL Molecular

Active Ingredients ( 2 Total)

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