Product manufactured by Sandoz Inc.

Application Nr Approved Date Route Status External Links
ANDA076942 2005-04-11 Topical RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Ketoconazole Shampoo, 2%, Is Indicated For The Treatment Of Tinea (pityriasis) Versicolor Caused By Or Presumed To Be Caused By Pityrosporum Orbiculare (also Known As Malassezia Furfur Or M. Orbiculare). Note: Tinea (pityriasis) Versicolor May Give Rise To Hyperpigmented Or Hypopigmented Patches On The Trunk Which May Extend To The Neck, Arms And Upper Thighs. Treatment Of The Infection May Not Immediately Result In Normalization Of Pigment To The Affected Sites. Normalization Of Pigment Following Successful Therapy Is Variable And May Take Months, Depending On Individual Skin Type And Incidental Sun Exposure. Although Tinea Versicolor Is Not Contagious, It May Recur Because The Organism That Causes The Disease Is Part Of The Normal Skin Flora.

All Formulated Excipients (7 Total)

Name Structure Kind Function Status
1. Disodium Laureth Sulfosuccinate DISODIUM LAURETH SULFOSUCCINATE Molecular
2. Hydrochloric Acid HYDROCHLORIC ACID Molecular B&N-Buffer & neutralizing agent , MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
3. Peg-120 Methyl Glucose Dioleate PEG-120 METHYL GLUCOSE DIOLEATE Unresolved
4. Imidurea IMIDUREA Molecular
5. Sodium Chloride SODIUM CHLORIDE Unresolved GRAS-Generally recognized as safe.
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.
7. Fd&c Red No. 40 FD&C RED NO. 40 Molecular

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Ketoconazole KETOCONAZOLE ZINC643153