Ammonium Lactate
Generic: AMMONIUM LACTATE
Basic Information
Manufacturer
REMEDYREPACK INC.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
TOPICAL
FDA Set ID
030e8bd1-0ff3-479f-aa77-16fab701a111
Indications & 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.
The use of Ammonium Lactate Cream, 12% should be discontinued if any hypersensitivity is observed.
Adverse Reactions
ADVERSE REACTIONS In controlled clinical trials of patients with ichthyosis vulgaris, the most frequent adverse reactions in patients treated with Ammonium Lactate Cream, 12% were rash (including erythema and irritation) and burning/stinging.
Each was reported in approximately 10 to 15% of patients.
In addition, itching was reported in approximately 5% of patients.
In controlled clinical trials of patients with xerosis, the most frequent adverse reactions in patients treated with Ammonium Lactate Cream, 12% were transient burning, in about 3% of patients, stinging, dry skin and rash, each reported in approximately 2% of patients.
Each was reported in approximately 10 to 15% of patients.
In addition, itching was reported in approximately 5% of patients.
In controlled clinical trials of patients with xerosis, the most frequent adverse reactions in patients treated with Ammonium Lactate Cream, 12% were transient burning, in about 3% of patients, stinging, dry skin and rash, each reported in approximately 2% of patients.