Ammonium Lactate Cream

*Ammonium Lactate Cream, 12% is a formulation of 12% lactic acid neutralized with ammonium hydroxide, as ammonium lactate with a pH of 4.4 - 5.4. Ammonium Lactate Cream, 12% also contains cetyl alcohol, glycerin, glyceryl stearate, laureth-4, light mineral oil, magnesium aluminum silicate, methylcellulose, methylparaben, PEG-100 stearate, polyoxyl 40 stearate, propylene glycol, propylparaben, and purified water.

Lactic acid is a racemic mixture of 2-hydroxypropanoic acid and has the following structural formula:

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

Ammonium Lactate Cream, 12% is contraindicated in those patients with a history of hypersensitivity to any of the label ingredients.

Sun exposure to areas of the skin treated with Ammonium Lactate Cream, 12% should be minimized or avoided (see PRECAUTIONS). Use of this product should be discontinued if hypersensitivity to any of the ingredients is noted.

In controlled clinical trials of patients with ichthyosis vulgaris, the most frequent adverse reactions in patients treated with Ammonium Lactate Cream were rash (including erythema and irritation) and burning/stinging. Each was reported in approximately 10-15% 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 were transient burning, in about 3% of patients, stinging, dry skin and rash, each reported in approximately 2% of patients.

Ammonium Lactate Cream, 12% is available as follows:

385 g bottle (NDC 45802-493-26)

280 g carton (NDC 45802-493-83) containing two 140 g tubes (NDC 45802-493-98)

STORAGE

Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature].

Manufactured By Perrigo

Bronx, NY 10457

Distributed By Perrigo® Allegan, MI 49010 • www.perrigo.com

Rev 07-15

: 0A900 RC JX1