AMMONIUM LACTATE cream

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

Ammonium Lactate (UNII: 67M901L9NQ) (Lactic acid, unspecified form - UNII:33X04XA5AT)

Disponible desde:

Taro Pharmaceuticals U.S.A., Inc.

Vía de administración:

TOPICAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

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.

Resumen del producto:

Ammonium Lactate Cream, 12% is available in cartons of 280 g (2-140 g laminate tubes) (NDC 51672-1301-4) and a 385 g plastic bottle (NDC 51672-1301-0). Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Estado de Autorización:

Abbreviated New Drug Application

Ficha técnica

AMMONIUM LACTATE- AMMONIUM LACTATE CREAM
TARO PHARMACEUTICALS U.S.A., INC.
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AMMONIUM LACTATE CREAM 12%*
RX ONLY.
FOR DERMATOLOGICAL USE ONLY.
NOT FOR OPHTHALMIC, ORAL OR INTRAVAGINAL USE.
DESCRIPTION
*Ammonium Lactate Cream, 12% specially formulates 12% lactic acid, as
ammonium
lactate to provide a cream pH of 4.5 to 5.5. Ammonium Lactate Cream,
12% 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) are felt to 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
cream using human
cadaver skin indicates that approximately 6.1% of the material was
absorbed after 68
hours.
INDICATIONS AND USAGE
Ammonium Lactate Cream, 12% is indicated for the treatment of
ichthyosis vulgaris and
xerosis.
CONTRAINDICATIONS
Ammonium Lactate Cream, 12% is contraindicated in those patients with
a history of
hypersensitivity to any of the label ingredients.
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.
PRECAUTIONS
GENERAL
For external use only. Stinging or burning may occur when applied to
skin with fissures,
erosions, or that is otherwise abraded (for example, after shaving th