AMMONIUM LACTATE lotion

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 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.

उत्पाद समीक्षा:

Ammonium Lactate Lotion, 12% is available as follows: 400 g bottle (NDC 63629-8611-1) 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 LOTION
BRYANT RANCH PREPACK
----------
AMMONIUM LACTATE LOTION, 12%*
RX ONLY
FOR DERMATOLOGIC USE ONLY
NOT FOR OPHTHALMIC, ORAL OR INTRAVAGINAL USE
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 discontinued if any
hypersensitivity is
observed.
PRECAUTIONS
GENERAL -
For external use only. Stinging or burning may occur when applied to
skin with fis