Is ammonium lactate cream approved by the FDA?

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The FDA approved ammonium lactate cream as the generic version of the brand name Lac-Hydrin. The FDA approved both medicines to treat abnormally dry skin and "fish scale disease." They have the same active ingredient -- 12% lactic acid. They carry the same FDA warnings. You must have a prescription for them. There are over-the-counter lotions that also contain 12% lactic acid (such as AmLactin and Kerasal). The FDA has not evaluated or approved these lotions to treat disease.