SALICYLIC ACID kit

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

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

Dostupno od:

Exact-Rx, Inc.

INN (International ime):

SALICYLIC ACID

Sastav:

SALICYLIC ACID 60 mg in 1 g

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

For Dermatologic Use: SA 6% 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). For Podiatric Use: SA 6% is a topical aid in the removal of excessive keratin on dorsal and plantar hyperkeratotic lesions. Topical preparations of 6% salicylic acid have been reported to be useful adjunctive therapy for verrucae plantares. SA 6% should not be used in any patient known to be sensitive to salicylic acid or any other listed ingredients. SA 6% should not be used in children under 2 years of age.

Proizvod sažetak:

Salicyclic Acid 6% Cream Kit, NDC 42808-0399-16, contains a 16 oz. (454 g) jar of Salicylic Acid Cream and a 12 fl. oz. (355 mL) bottle of Hydrating Cleanser. Salicyclic Acid 6% Lotion Kit, NDC 42808-0399-08, contains an 8 oz. (277 g) bottle of Salicylic Acid Lotion and a 12 fl. oz. and a 12 fl. oz. (355 mL) Hydrating Cleanser.. Store at 25°C (77°F); excursions permitted to 15 to 30°C (59°-86°F). See USP Controlled Room Temperature. Protect from freezing. Manufactured in the U.S.A. for Exact-Rx, Inc., Melville, NY 11747 00-0399-16-205-00/00-399-08-205-00 Iss:8/11

Status autorizacije:

unapproved drug other

Svojstava lijeka

SALICYLIC ACID- SALICYLIC ACID
EXACT-RX, 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 6% CREAM KIT
SALICYLIC ACID 6% LOTION KIT
RX ONLY
FOR DERMATOLOGICAL USE ONLY. NOT FOR OPHTHALMIC, ORAL OR
INTRAVAGINAL USE.
DESCRIPTION
SA 6% CREAM contains 6% salicylic acid USP incorporated into a
specially formulated oil and water
emulsion (0IW)™™ vehicle consisting of trolamine, purified water,
methyl paraben, propyl paraben,
phenoxyethanol, PEG 100 stearate, mineral oil, glyceryl stearate SE,
dimethicone 350, ammonium
lactate, disodium EDTA, glycerine, cetearyl alcohol (and) PEG-3,
distearoylamidoethylmonium
methosulfate (and) polysorbate 60, cetyl alcohol and cetearyl alcohol.
SA 6% LOTION contains 6% w/w salicylic acid USP incorporated into a
specially formulated oil and
water emulsion (0IW)™ vehicle consisting of trolamine, purified
water, methyl paraben, propyl
paraben, PEG 100 stearate, cetyl alcohol, mineral oil, glyceryl
stearate SE, dimethicone 350, ammonium
lactate, disodium EDTA, glycerine, cetearyl alcohol (and) PEG-3
distearoylamidoethylmonium
methosulfate (and) polysorbate 60.
Salicylic acid is the 2-hydroxy derivative of benzoic acid having the
following structure:
This (0IW)™ formulation has been shown to provide gradual and
prolonged release of the active
ingredient into the skin.
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 ap