SALICYLIC ACID aerosol, foam

Страна: США

мова: англійська

Джерело: NLM (National Library of Medicine)

Активний інгредієнт:

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

Доступна з:

Acella Pharmaceuticals, LLC

ІПН (Міжнародна Ім'я):

SALICYLIC ACID

Склад:

SALICYLIC ACID 6 g in 100 g

Адміністрація маршрут:

TOPICAL

Тип рецепту:

PRESCRIPTION DRUG

Терапевтичні свідчення:

For Dermatologic Use: Salicylic Acid 6% Foam is a topical aid in the removal of excessive keratin in hyperkeratotic skin disorders, including verrucae and the various ichthyoses, keratosis palmaris and plantaris, keratosis pilaris, pityriasis rubra pilaris and psoriasis. For Podiatric Use: Salicylic Acid 6% Foam is a topical aid in the removal of excessive keratin on dorsal and plantar hyperkeratotic lesions. Salicylic Acid 6% Foam should not be used in any patient known to be sensitive to salicylic acid or any other listed ingredients. Salicylic Acid 6% Foam should not be used in children under 2 years of age.

Огляд продуктів:

Salicylic Acid 6% Foam is supplied in a 70 gram or 2.5 ounce aerosolized canister bearing the NDC Number 42192-112-70 and a 200 gram or 7.1 ounce aerolized canister bearing the NDC Number 42192-130-02 .

Статус Авторизація:

unapproved drug other

Характеристики продукта

SALICYLIC ACID- SALICYLIC ACID AEROSOL, FOAM
ACELLA PHARMACEUTICALS, 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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SALICYLIC ACID 6% FOAM
_(salicylic acid in a water and lipid based foam, 6%)_
RX ONLY
DESCRIPTION
Salicylic Acid 6% Foam is applied topically and used in the removal of
excessive keratin in
hyperkeratotic skin disorders. Each gram of Salicylic Acid 6% Foam
contains salicylic acid
6% as the active ingredient, and the following inactive ingredients:
dimethicone,
ethylparaben, glycerin, methylcellulose, methylparaben,
phenoxyethanol, polyoxyl 40
stearate, polysorbate 20, polysorbate 80, povidone, propylene glycol,
propylparaben,
purified water, sodium citrate, sodium hydroxide, stearic acid and
trolamine and in
propellants butane and propane.
CHEMICAL STRUCTURE
Salicylic acid is a 2-hydroxy derivative of benzoic acid having the
following chemical
structure:
CLINICAL PHARMACOLOGY
Salicylic acid has been shown to produce desquamation of the horny
layer of skin while
not affecting qualitative or quantitative changes in structure of the
viable epidermis. The
mechanism of action has been attributed to dissolution of
intercellular cement
substance. In a study of the percutaneous absorption of salicylic acid
from Salicylic Acid
6% Foam in four patients with extensive active psoriasis, Taylor and
Halprin showed that
peak serum 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/100mL). Peak serum levels
occurred within 5
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 level