SALICYLIC ACID kit

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

PruGen, Inc.

INN (International Name):

SALICYLIC ACID

Composition:

SALICYLIC ACID 27.24 g in 1 g

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Salicylic Acid 6% (w/w) Cream 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: Salicylic Acid 6% (w/w) Cream 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) Cream should not be used in any patient known to be sensitive to salicylic acid or any other listed ingredients. Salicylic Acid 6% (w/w) Cream should not be used in children under 2 years of age.

Product summary:

Salicylic Acid 6% (w/w) Cream Kit includes a 16 oz. (454 g) jar with Salicylic Acid 6% (w/w) Cream (NDC 42546-270-16) as well as a complimentary 12 fl. oz. PruDrate Hydrating Cleanser. Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (between 59°F and 86°F). Brief exposure to temperatures up to 40°C (104°F) may be tolerated provided the mean kinetic temperature does not exceed 25°C (77°F); however, such exposure should be minimized. Do not freeze.

Authorization status:

unapproved drug other

Summary of Product characteristics

SALICYLIC ACID- SALICYLIC ACID
PRUGEN, 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
RX ONLY
FOR DERMATOLOGICAL USE ONLY. NOT FOR OPHTHALMIC, ORAL OR
INTRAVAGINAL USE.
DESCRIPTION
Salicylic Acid 6% (w/w) Cream contains salicylic acid, USP 6% in a
cream base composed
of ammonium lactate, cetearyl alcohol, cetearyl alcohol (and) PEG-3
distearoylamidoethylmonium methosulfate (and) polysorbate 60, cetyl
alcohol,
dimethicone 350, disodium EDTA, glycerine, glyceryl stearate SE,
methylparaben, mineral
oil, PEG-100 stearate, phenoxyethanol, propylparaben, purified water
and trolamine.
Salicylic acid is the 2-hydroxy derivative of benzoic acid having the
following structure:
This 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 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 extracellular space, patients with a contracted
extracellular space due
to dehydration or diuretics have higher salicylate levels than those
with a normal
extracellular sp