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Laclotion (Ammonium Lactate Topical) - Description and Clinical Pharmacology

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For Dermatologic use Only. Not for Ophthalmic, Oral or Intravaginal use.

DESCRIPTION

LAClotion™ (ammonium lactate) specially formulates 12% lactic acid, neutralized with ammonium hydroxide, as ammonium lactate to provide a lotion pH of 4.5-5.5. LAClotion™ also contains light mineral oil, glyceryl stearate, PEG-100 stearate, propylene glycol, polyoxyl 40 stearate, glycerin, magnesium aluminum silicate, laureth-4, cetyl alcohol, methylcellulose, methyl and propyl parabens, and water. 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, 12% using human cadaver skin indicates that approximately 5.8% of the material was absorbed after 68 hours.

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