SALICYLIC ACID aerosol, foam

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

Acella Pharmaceuticals, LLC

Via di somministrazione:

TOPICAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

INDICATIONS AND USAGE 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. CONTRAINDICATIONS 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.

Dettagli prodotto:

Salicylic Acid 6% Foam is supplied in a 70 gram or 2.5 ounce aerosolized canister bearing the NDC# 42192-112-70. Store at controlled room temperature 15° - 25°C(59° - 77°F). Contains flammable materials. Contents under pressure. Do not puncture and/or incinerate the containers. Do not expose to temperatures over 120°F (48°C) even when empty.

Stato dell'autorizzazione:

unapproved drug other

Scheda tecnica

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
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:
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 leverls (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 levels than those with a normal extracellular space. (See
PRECAUTIONS).
The major metabol