Application Nr Approved Date Route Status External Links
ANDA075213 1998-12-24 Topical RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Tretinoin Gel And Cream Are Indicated For Topical Application In The Treatment Of Acne Vulgaris. The Safety And Efficacy Of The Long-Term Use Of This Product In The Treatment Of Other Disorders Have Not Been Established.

All Formulated Excipients (6 Total)

Name Structure Kind Function Status
1. Butylated Hydroxytoluene BUTYLATED HYDROXYTOLUENE Molecular
2. Isopropyl Myristate ISOPROPYL MYRISTATE Molecular
3. Polyoxyl 40 Stearate POLYOXYL 40 STEARATE Unresolved
4. Stearyl Alcohol STEARYL ALCOHOL Molecular
5. Xanthan Gum XANTHAN GUM Unresolved EMUL-Emulsifier FS-Substances permitted as optional ingredient in a standardized food.
6. 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