SALEX- salicylic acid cream SALEX- salicylic acid lotion

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

Salicylic acid (UNII: O414PZ4LPZ) (Salicylic acid - UNII:O414PZ4LPZ)

Disponível em:

Coria Laboratories

DCI (Denominação Comum Internacional):

Salicylic acid

Composição:

Salicylic acid 60 mg in 1 g

Via de administração:

TOPICAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

For Dermatologic Use: Salex is a topical aid in the removal of excessive keratin in hyperkeratotic skin disorders, including verrucae, and the various ichthyoses (vulgaris, sex-linked and lamellar), keratosis palmaris and plantaris, keratosis pilaris, pityriasis rubra pilaris, and psoriasis (including body, scalp, palms and soles). For Podiatric Use: Salex is a topical aid in the removal of excessive keratin on dorsal and plantar hyperkeratotic lesions. Topical preparations of 6% salicylic acid have been reported to be useful adjunctive therapy for verrucae plantares. Salex should not be used in any patient known to be sensitive to salicylic acid or any other listed ingredients. Salex should not be used in children under 2 years of age.

Resumo do produto:

Salex® Cream is available in a 454 g (16 oz.) jar - NDC 13548-010-16 Salex® Lotion is available in a 8 fl. oz. (237 mL) bottle - NDC 13548-011-08 Store at controlled room temperature 20° to 25°C (68° to 77°F). Do not freeze.

Status de autorização:

unapproved drug other

Características técnicas

SALEX- SALICYLIC ACID CREAM
SALEX- SALICYLIC ACID LOTION
CORIA LABORATORIES
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this labeling has not been_
_approved by FDA. For further information about unapproved drugs,
click here._
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SALEX (6% SALICYLIC ACID) CREAM
SALEX (6% SALICYLIC ACID) LOTION
DESCRIPTION
Salex
Cream contains 6% salicylic acid USP incorporated into a patented
Multivesicular Emulsion
(MVE ) vehicle consisting of ammonium lactate, behentrimonium
methosulfate, cetearyl alcohol, cetyl
alcohol, dimethicone 360, disodium EDTA, glycerin, glyceryl stearate
SE, methylparaben, mineral oil,
PEG-100 stearate, phenoxyethanol, propylparaben, purified water and
trolamine.
Salex Lotion contains 6% w/w salicylic acid USP incorporated into a
patented Multivesicular Emulsion
(MVE) vehicle consisting of ammonium lactate, behentrimonium
methosulfate, cetearyl alcohol, cetyl
alcohol, dimethicone 360, disodium EDTA, glycerin, glyceryl stearate
SE, methylparaben, mineral oil,
PEG-100 stearate, propylparaben, purified water and trolamine.
Salicylic acid is the 2-hydroxy derivative of benzoic acid having the
following structure:
This MVE formulation has been shown to provide gradual and prolonged
release of the active
ingredient into the skin.
CLINICAL PHARMACOLOGY
Salicylic acid has been shown to produce desquamation of the horny
layer of skin while not effecting
qualitative or quantitative changes in the structure of the viable
epidermis. The mechanism of action has
been attributed to a dissolution of intercellular cement substance. In
a study of the percutaneous
absorption of salicylic acid in a 6% salicylic acid gel in four
patients with extensive active psoriasis,
Taylor and Halprin showed that the peak serum salicylate levels never
exceeded 5 mg/100 mL even
though more than 60% of the applied salicylic acid was absorbed.
Systemic toxic reactions are usually
associated with much higher serum levels (30 to 40 mg/100 mL). Peak
serum levels occurred within 5
hours of the topica