Application Nr Approved Date Route Status External Links
NDA020475 2014-01-28 Topical RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Tretinoin Gel Microsphere, 0.1% And 0.04%, Is A Retinoid Indicated For Topical Application In The Treatment Of Acne Vulgaris. Tretinoin Gel Microsphere, 0.1% And 0.04%, Is A Retinoid, Indicated For Topical Treatment Of Acne Vulgaris. (1)

All Formulated Excipients (8 Total)

Name Structure Kind Function Status
1. Butylated Hydroxytoluene BUTYLATED HYDROXYTOLUENE Molecular
2. Carbomer Homopolymer Type B (allyl Pentaerythritol Crosslinked) CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) Unresolved
3. Edetate Disodium Anhydrous EDETATE DISODIUM ANHYDROUS Molecular
4. Glycerin GLYCERIN Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
5. Ppg-20 Methyl Glucose Ether Distearate PPG-20 METHYL GLUCOSE ETHER DISTEARATE Unresolved
6. Propylene Glycol PROPYLENE GLYCOL Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
7. Water WATER Molecular
8. Sorbic Acid SORBIC ACID Molecular PRES-Chemical preservative GRAS-Generally recognized as safe.

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Tretinoin TRETINOIN ZINC22066351

Comments