AMMONIUM LACTATE cream

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

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

Tillgänglig från:

Padagis Israel Pharmaceuticals Ltd

INN (International namn):

AMMONIUM LACTATE

Sammansättning:

LACTIC ACID 12 g in 100 g

Administreringssätt:

TOPICAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

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.

Produktsammanfattning:

Ammonium Lactate Cream, 12% is available as follows: 385 g bottle (NDC 45802-493 -26) 280 g carton (NDC 45802-493 -83) containing two 140 g tubes (NDC 45802-493 -98) Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature]. Manufactured By Padagis Minneapolis, MN 55427 www.padagis.com Rev 12-21

Bemyndigande status:

Abbreviated New Drug Application

Produktens egenskaper

AMMONIUM LACTATE- AMMONIUM LACTATE CREAM
PADAGIS ISRAEL PHARMACEUTICALS LTD
----------
AMMONIUM LACTATE CREAM, 12%*
RX ONLY
FOR DERMATOLOGIC USE ONLY
NOT FOR OPHTHALMIC, ORAL OR INTRAVAGINAL USE
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
Use of this product should be discontinued if hypersensitivity to any
of the ingredients is noted. Sun exposure
to areas of the skin treated with ammonium lactate cream should be
minimized or avoided (see
PRECAUTIONS).
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