AMMONIUM LACTATE cream

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

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

Disponível em:

Nnodum Pharmaceuticals

DCI (Denominação Comum Internacional):

AMMONIUM LACTATE

Composição:

AMMONIUM LACTATE 17 g in 1 g

Via de administração:

TOPICAL

Tipo de prescrição:

OTC DRUG

Indicações terapêuticas:

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

Resumo do produto:

Ammonium lactate Cream, 12% is available in a 140g (NDC # 63044-404-20) plastic tube. Store at controlled room temperature 15° C - 30° C (59° F - 86° F). Manufactured for: Nnodum Pharmaceuticals Cincinnati, Ohio 45229 By: EMS Contract Manufacturing Revised January 2008 Ammonium lactate Lotion

Status de autorização:

OTC monograph not final

Características técnicas

AMMONIUM LACTATE - AMMONIUM LACTATE CREAM
NNODUM PHARMACEUTICALS
_Disclaimer: Most OTC drugs are not reviewed and approved by FDA,
however they may be marketed if they_
_comply with applicable regulations and policies. FDA has not
evaluated whether this product complies._
----------
AMMONIUM LACTATE CREAM
63044-404-20
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.
INGREDIENTS: Ammonium Lactate Cream, 12% also contains cetyl alcohol,
glycerin, glyceryl stearate,
light mineral oil, magnesium aluminum silicate, methyl and propyl
parabens, Carbomer 940, PEG-100
stearate, polysorbate 85, triethanolamine, propylene glycol,
Petrolatum and Sodium PCA, stearic acid
and 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
Cream using human cadaver skin
indicates that approximately 5.8% of the material was absorbed after
68 hours.
INDICATIONS AND USAGE
Ammonium Lactate Cream is indicated for the treatment of dry, scaly
skin (xerosis) and ichthyosis
vulgaris and for temporary relief of itching associated with these
conditions.
CONTRAINDICATIONS
Ammonium Lactate Cream 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). The use of Ammo