SALICYLIC ACID gel

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

有効成分:

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

から入手可能:

Acella Pharmaceuticals, LLC

INN（国際名）:

SALICYLIC ACID

構図:

SALICYLIC ACID 60 mg in 1 g

投与経路:

TOPICAL

処方タイプ:

PRESCRIPTION DRUG

適応症:

INDICATIONS AND USAGE For the removal of excess keratin in hyperkeratotic disorders, including scaling associated with psoriasis or thickened skin of palms and soles, corns and calluses. CONTRAINDICATIONS Salicylic Acid 6% Gel should not be used in any patient known to be sensitive to salicylic acid or any other listed ingredients. Salicylic Acid 6% Gel should not be used in children under 2 years of age.

製品概要:

HOW SUPPLIED Salicylic Acid 6% Gel is supplied in a 40 gram plastic tube bearing the NDC Number 42192-134-40.

認証ステータス:

unapproved drug other

製品の特徴

SALICYLIC ACID- SALICYLIC ACID GEL
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% GEL
RX ONLY
FOR TOPICAL USE ONLY. NOT FOR OPHTHALMIC, ORAL OR INTRAVAGINAL
USE.
DESCRIPTION
Salicylic Acid 6% Gel is applied topically and used in the removal of
excessive keratin in
hyperkeratotic skin disorders. Each gram of Salicylic Acid 6% Gel
contains salicylic acid
6% as the active ingredient, and the following inactive ingredients:
hydroxypropylcellulose and propylene glycol.
CHEMICAL STRUCTURE
Salicylic acid is the 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% Gel in four patients with extensive active psoriasis, Taylor
and Halprin
showed
that 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/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 metabolites identified in the urine after topical
administration are salicyluric
acid (52%), salicylate glucuronides (42%), and free salicylic acid
(6%).
The urinar