SALICYLIC ACID shampoo

Страна: США

мова: англійська

Джерело: NLM (National Library of Medicine)

Активний інгредієнт:

SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)

Доступна з:

Perrigo New York Inc

ІПН (Міжнародна Ім'я):

SALICYLIC ACID

Склад:

SALICYLIC ACID 6 mg in 100 mL

Тип рецепту:

PRESCRIPTION DRUG

Статус Авторизація:

unapproved drug other

Характеристики продукта

SALICYLIC ACID- SALICYLIC ACID SHAMPOO
PERRIGO NEW YORK INC
_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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SALICYLIC ACID SHAMPOO, 6% (W/W)
RX ONLY
FOR DERMATOLOGICAL USE ONLY.
NOT FOR OPHTHALMIC, ORAL OR INTRAVAGINAL USE.
DESCRIPTION
Salicylic Acid Shampoo, 6% (w/w) contains salicylic acid USP, in a
vehicle consisting of acrylates
copolymer, behentrimonium chloride, cocamidopropyl betaine, disodium
EDTA, glycerin, isopropyl
alcohol, methylparaben, propylene glycol, propylparaben, purified
water, quaternium 26, sodium laureth
sulfate, and trolamine.
Salicylic acid is the 2-hydroxy derivative of benzoic acid with 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 (42%) and free salicylic