Application Nr Approved Date Route Status External Links
NDA021844 2006-10-20 Topical RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Desonate® Is Indicated For The Treatment Of Mild To Moderate Atopic Dermatitis In Patients 3 Months Of Age And Older. Patients Should Be Instructed To Use Desonate For The Minimum Amount Of Time As Necessary To Achieve The Desired Results Because Of The Potential For Desonate To Suppress The Hypothalamic-Pituitary-Adrenal (hpa) Axis [see Warnings And Precautions (5.1)]. Treatment Should Not Exceed 4 Consecutive Weeks [see Dosage And Administration (2)]. Desonate® Is A Corticosteroid Indicated For The Topical Treatment Of Mild To Moderate Atopic Dermatitis In Patients 3 Months Of Age And Older. (1)

All Formulated Excipients (6 Total)

Name Structure Kind Function Status
1. Glycerin GLYCERIN Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
2. Propylene Glycol PROPYLENE GLYCOL Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
3. Edetate Disodium EDETATE DISODIUM Molecular
4. Methylparaben METHYLPARABEN Molecular PRES-Chemical preservative REG-Food additives for which a petition has been filed and a regulation issued.
5. Propylparaben PROPYLPARABEN Molecular PRES-Chemical preservative REG-Food additives for which a petition has been filed and a regulation issued.
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 ( 1 Total)

Name Structure ZINC ID(s)
1. Desonide DESONIDE ZINC4212851

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