Application Nr Approved Date Route Status External Links
ANDA202894 2015-10-30 Topical RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Clotrimazole And Betamethasone Dipropionate Cream Usp 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. Clotrimazole And Betamethasone Dipropionate Cream Usp Contains A Combination Of Clotrimazole Usp, An Azole Antifungal, And Betamethasone Dipropionate Usp, 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)

All Formulated Excipients (6 Total)

Name Structure Kind Function Status
1. Ceteareth-30 CETEARETH-30 Unresolved
2. Mineral Oil MINERAL OIL Unresolved
3. Sodium Phosphate, Monobasic, Monohydrate SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE Molecular
4. Phosphoric Acid PHOSPHORIC ACID Molecular MISC-Miscellaneous , SANI-Sanitizing agent REG-Food additives for which a petition has been filed and a regulation issued.
5. Propylene Glycol PROPYLENE GLYCOL Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
6. Sodium Hydroxide SODIUM HYDROXIDE Unresolved BC-Boiler compound , B&N-Buffer & neutralizing agent , MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.

Active Ingredients ( 2 Total)

Comments