Ammonium Lactate

FDA Drug Profile — Ammonium Lactate

Drug Details

Generic Name
Ammonium Lactate
Brand Names
Ammonium Lactate
Application Number
ANDA075570
Sponsor
Padagis Israel Pharmaceuticals Ltd
NDC Codes
13
Dosage Forms
LOTION, CREAM, LIQUID
Routes
TOPICAL
Active Ingredients
AMMONIUM LACTATE

Indications and Usage

INDICATIONS AND USAGE Ammonium Lactate Cream, 12% is indicated for the treatment of ichthyosis vulgaris and xerosis.

Warnings

WARNING Sun exposure to areas of the skin treated with Ammonium Lactate Cream, 12% should be minimized or avoided (see PRECAUTIONS section). The use of Ammonium Lactate Cream, 12% should be discontinued if any hypersensitivity is observed.