SALEX- salicylic acid shampoo

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

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

Доступна с:

Bausch Health US, LLC

ИНН (Международная Имя):

Salicylic acid

состав:

Salicylic acid 60 mg in 1 mL

Администрация маршрут:

TOPICAL

Тип рецепта:

PRESCRIPTION DRUG

Терапевтические показания :

For Dermatologic Use: Salex® Shampoo 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® Shampoo 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® Shampoo should not be used in any patient known to be sensitive to salicylic acid or any other listed ingredients. Salex® Shampoo should not be used in children under 2 years of age.

Обзор продуктов:

Salex® Shampoo is available in 6 fl. oz. (177 mL) bottle (NDC 13548-012-06). Store at controlled room temperature 20° to 25°C (68° to 77°F). Do not freeze. Manufactured for: Valeant Pharmaceuticals North America LLC Bridgewater, NJ 08807 USA by: Denison Pharmaceuticals, LLC Lincoln, RI 02865 USA REORDER NO. Salex® Shampoo: 13548-012-06 U.S. Patent 6,709,663 Salex is a trademark of Valeant Pharmaceuticals International, Inc. or its affiliates. ©Valeant Pharmaceuticals North America LLC 9492702

Статус Авторизация:

unapproved drug other

Характеристики продукта

SALEX- SALICYLIC ACID SHAMPOO
BAUSCH HEALTH US, LLC
_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% W/W SALICYLIC ACID) SHAMPOO
RX ONLY
FOR DERMATOLOGIC USE ONLY. NOT FOR OPHTHALMIC, ORAL OR
INTRAVAGINAL USE.
DESCRIPTION
Salex
Shampoo contains 6% w/w salicylic acid USP in a vehicle consisting of
purified
water, acrylates copolymer, sodium laureth sulfate, trolamine,
quaternium 26 and
propylene glycol, cocamidopropyl betaine, behentrimonium methosulfate
and cetearyl
alcohol, propylparaben, methylparaben, glycerin, disodium EDTA and
chamomile tea
fragrance.
Salicylic acid is the 2-hydroxy derivative of benzoic acid having the
following structure:
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 five hours of the topical
application under occlusion.
The sites were occluded for 10 hours over the entire body surface
below the neck. Since
salicylates are distributed in the extracellular space, patients with
a contracted
extracellular space due to dehydration or diuretics have higher
salicylate levels than
those with a normal extracellular space. (See PRECAUTIONS)
The major metabolites identified in the urine after topical
administration are salicyluric
acid (52%), salicylate glucuronides