Application Nr Approved Date Route Status External Links
ANDA075774 2002-05-01 Topical RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Ammonium Lactate Cream, 12% Is Indicated For The Treatment Of Ichthyosis Vulgaris And Xerosis.

All Formulated Excipients (10 Total)

Name Structure Kind Function Status
1. Glycerin GLYCERIN Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
2. Glyceryl Monostearate GLYCERYL MONOSTEARATE Molecular
3. Laureth-4 LAURETH-4 Unresolved
4. Light Mineral Oil LIGHT MINERAL OIL Unresolved
5. Magnesium Aluminum Silicate MAGNESIUM ALUMINUM SILICATE Unresolved
6. Methylcelluloses METHYLCELLULOSES Unresolved
7. Methylparaben METHYLPARABEN Molecular PRES-Chemical preservative REG-Food additives for which a petition has been filed and a regulation issued.
8. Peg-100 Stearate PEG-100 STEARATE Unresolved
9. Polyoxyl 40 Stearate POLYOXYL 40 STEARATE Unresolved
10. Propylene Glycol PROPYLENE GLYCOL Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Ammonium Lactate AMMONIUM LACTATE ZINC4658560

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