AMMONIUM LACTATE lotion

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

AMMONIUM LACTATE (UNII: 67M901L9NQ) (LACTIC ACID, DL- - UNII:3B8D35Y7S4)

Disponible des:

Physicians Total Care, Inc.

Designació comuna internacional (DCI):

AMMONIUM LACTATE

Composición:

LACTIC ACID, DL- 12 g in 100 g

Vía de administración:

TOPICAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Ammonium Lactate Lotion, 12% is indicated for the treatment of dry, scaly skin (xerosis) and ichthyosis vulgaris, and for the temporary relief of itching associated with these conditions. Ammonium Lactate Lotion, 12% is contraindicated in those patients with a history of hypersensitivity to any of the label ingredients.

Resumen del producto:

Ammonium Lactate Lotion, 12% is available as follows: 225 g bottle   (NDC 54868-4599-0) 400 g bottle   (NDC 54868-4599-1) Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature].

Estat d'Autorització:

Abbreviated New Drug Application

Fitxa tècnica

AMMONIUM LACTATE - AMMONIUM LACTATE LOTION
PHYSICIANS TOTAL CARE, INC.
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AMMONIUM LACTATE LOTION, 12%*
FOR DERMATOLOGIC USE ONLY
NOT FOR OPHTHALMIC, ORAL OR INTRAVAGINAL USE
RX ONLY
DESCRIPTION
*Ammonium Lactate Lotion, 12% specially formulates 12% lactic acid
neutralized with ammonium
hydroxide, as ammonium lactate to provide a lotion pH of 4.5 - 5.5. It
also contains cetyl alcohol,
fragrance, 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) 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.
INDICATIONS AND USAGE
Ammonium Lactate Lotion, 12% is indicated for the treatment of dry,
scaly skin (xerosis) and ichthyosis
vulgaris, and for the temporary relief of itching associated with
these conditions.
CONTRAINDICATIONS
Ammonium Lactate Lotion, 12% is contraindicated in those patients with
a history of hypersensitivity to
any of the label ingredients.
WARNING
Sun exposure (natural or artificial sunlight) to areas of the skin
treated with Ammonium Lactate Lotion,
12% should be minimized or avoided (see PRECAUTIONS). The use of
Ammonium Lactate Lotion,
12% should be minimized or avoided (see PRECAUTIONS). The use of
Ammonium Lactate Lotion,
12% should be discontinued if any hypersensitivity is observed.
PRECA