AMMONIUM LACTATE cream

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

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

थमां उपलब्ध:

Bryant Ranch Prepack

प्रशासन का मार्ग:

TOPICAL

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

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.

उत्पाद समीक्षा:

Ammonium Lactate Cream, 12% is available as follows: 280 g carton (NDC 63629-8608-1) containing two 140 g tubes (NDC 63629-8608-1) STORAGE Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature].

प्राधिकरण का दर्जा:

Abbreviated New Drug Application

उत्पाद विशेषताएं

AMMONIUM LACTATE- AMMONIUM LACTATE CREAM
BRYANT RANCH PREPACK
----------
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 beca