AMMONIUM LACTATE cream

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

AMMONIUM LACTATE (UNII: 67M901L9NQ) (LACTIC ACID - UNII:33X04XA5AT)

Disponible des:

REMEDYREPACK 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 as follows: NDC: 70518-2449-00 PACKAGING: 2 in 1 CARTON, 140 g in 1 TUBE, TYPE 0 STORAGE Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature]. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

Estat d'Autorització:

Abbreviated New Drug Application

Fitxa tècnica

AMMONIUM LACTATE- AMMONIUM LACTATE CREAM
REMEDYREPACK INC.
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AMMONIUM LACTATE CREAM, 12%*
FOR DERMATOLOGIC USE ONLY
NOT FOR OPHTHALMIC, ORAL OR INTRAVAGINAL USE
RX ONLY
DESCRIPTION
*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:
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). Use of this product should
be
discontinued if hypersensitivity to any of the ingredients is noted.
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 the
legs). Caution is
advised when used on the face becaus