Ammonium Lactate - Ammonium Lactate lotion prescribing information
INDICATIONS AND USAGE
Ammonium Lactate Lotion is indicated for the treatment of dry, scaly skin (xerosis) and ichthyosis vulgaris and for temporary relief of itching associated with these conditions.
DOSAGE AND ADMINISTRATION
Shake well. Apply to the affected areas and rub in thoroughly. Use twice daily or as directed by a physician.
CONTRAINDICATIONS
Ammonium Lactate Lotion is contraindicated in those patients with a history of hypersensitivity to any of the label ingredients.
ADVERSE REACTIONS
The most frequent adverse experiences in patients with xerosis are transient stinging (1 in 30 patients), burning (1 in 30 patients), erythema (1 in 50 patients) and peeling (1 in 60 patients). Other adverse reactions which occur less frequently are irritation, eczema, petechiae, dryness and hyperpigmentation. Due to the more severe initial skin conditions associated with ichthyosis, there was a higher incidence of transient stinging, burning and erythema (each occurring in 1 in 10 patients).
DESCRIPTION
•Ammonium Lactate Lotion, 12% specially formulates 12% lactic acid, as ammonium lactate to provide a lotion pH of 4.5 to 5.5. Ammonium Lactate Lotion also contains cetyl alcohol, glycerin, glyceryl monostearate, laureth-4, light mineral oil, magnesium aluminum silicate, methylcellulose, methylparaben, polyoxyethylene 100 stearate, polyoxyl stearate type II, propylene glycol, propylparaben, purified water, and for pH adjustment: lactic acid. Lactic acid is a racemic mixture of 2-hydroxypropanoic acid and has the following structural formula:

CLINICAL PHARMACOLOGY
Lactic acid is an alpha-hydroxy acid. It is a normal constituent of tissues and blood. The alpha-hydroxy acids (and their salts) may act as humectants when applied to the skin. This property may influence hydration of the stratum corneum. In addition, lactic acid, when applied to the skin, may act to decrease corneocyte cohesion. The mechanism(s) by which this is accomplished is not yet known. An in vitro study of percutaneous absorption of Ammonium Lactate Lotion using human cadaver skin indicates that approximately 5.8% of the material was absorbed after 68 hours.
HOW SUPPLIED
225 g (NDC 51672-1300-5) plastic bottle and 400 g (NDC 51672-1300-9) plastic bottle.
Store between 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].