SALICYLIC ACID cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Trinity Pharmaceuticals, LLC

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

For Dermatologic Use: Salicylic Acid 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: Salicylic Acid 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. Salicylic Acid 6% should not be used in any patient known to be sensitive to salicylic acid or any other listed ingredients. Salicylic Acid 6% should not be used in children under 2 years of age.

Product summary:

Salicylic Acid 6% Cream is available in 16 oz (454 g) bottles, NDC 54295-302-21 Salicylic Acid 6% Lotion is available in 16 fl. oz (473 mL) bottles, NDC 54295-303-21 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. Protect from freezing. Manufactured for: Trinity Pharmaceuticals, LLC 900 C Frederick Pike, Littlestown, PA 17340 TrinityPharmallc.com

Authorization status:

unapproved drug other

Summary of Product characteristics

SALICYLIC ACID- SALICYLIC ACID CREAM
TRINITY 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% CREAM
SALICYLIC ACID 6% LOTION
RX ONLY
FOR DERMATOLOGICAL USE ONLY. NOT FOR OPHTHALMIC, ORAL OR
INTRAVAGINAL USE.
INGREDIENTS
SALICYLIC ACID 6% CREAM contains 6% salicylic acid USP incorporated
into a specially
formulated oil and water emulsion 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,
glycerin, cetearyl
alcohol (and) PEG-3, distearoylamidoethylmonium methosulfate (and)
polysorbate 60,
cetyl alcohol and cetearyl alcohol.
SALICYLIC ACID 6% LOTION contains 6% w/w salicylic acid USP
incorporated into a
specially formulated oil and water emulsion 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.
DESCRIPTION
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
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 h