SALICYLIC ACID 6 PERCENT- salicylic acid shampoo

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

salicylic acid (UNII: O414PZ4LPZ) (salicylic acid - UNII:O414PZ4LPZ)

Dostępny od:

PruGen LLC

INN (International Nazwa):

salicylic acid

Skład:

salicylic acid 6 mg in 100 mL

Droga podania:

TOPICAL

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

Salicylic Acid 6% (w/w) 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). Salicylic Acid 6% (w/w) Shampoo is a topical aid in the removal of excessive keratin on the dorsal and plantar hyperkeratotic lesions. Topical preparations of 6% salicylic acid have been reported to be useful adjunctive therapy for verrucae plantares. Salicylic Acid 6% (w/w) Shampoo should not be used in any Patient known to be sensitive to salicylic acid or any other listed ingredients. Salicylic Acid 6% (w/w) Shampoo should not be used in children under 2 years of age.

Podsumowanie produktu:

Salicylic Acid 6% (w/w) Shampoo is available in 177mL plastic bottles (NDC 42546-279-06). Store at controlled room temperature 20°-25°C (68°-77°F). Do not freeze.

Status autoryzacji:

unapproved drug other

Charakterystyka produktu

SALICYLIC ACID 6 PERCENT- SALICYLIC ACID SHAMPOO
PRUGEN 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% (W/W) SHAMPOO
RX ONLY
FOR DERMATOLOGICAL USE ONLY. NOT FOR OPHTHALMIC,ORAL OR
INTRAVAGINAL USE.
DESCRIPTION
SHAMPOO contains 6% w/w salicylic acid USP in a vehicle composed of
purified water,
disodium laureth sulfosuccinate, cocamidopropyl betaine, hexylene
glycol,
linoleamidpropyl PG-dimonium chloride phosphate, polyquaternium-22,
propylene glycol,
sodium C14-16 olefin sulfonate, sodium citrate, sodium lauryl
sarcosinate, tetrasodium
EDTA, tocopherol acetate and 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 inter
cellular 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 extra cellular space, patients with
a contracted extra
cellular space due to dehydration or diuretics have a higher
salicylate levels than those
with a normal extra cellular space. (See PRECAUTIONS)
The major metabolites identified in the urine after topical
administration are salicyluric
acid