Salicylic Acid

SALICYLIC ACID- salicylic acid lotion
Nationwide Laboratories, 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.

INGREDIENTS

Salicylic Acid 6% Cream contains 6% salicylic acid USP incorporated into a specially formulated oil and water emulsion vehicle consisting of Ammonium Lactate, Cetyl Alcohol, Dimethicone, Disodium EDTA, Glycerin, Methyl Paraben, Mineral Oil, PEG-100 , Phenoxy Ethanol, Polysorbate – 80, Propyp Paraben, Trolamine, Water

Salicylic Acid 6% Lotion contains 6% w/w salicylic acid USP incorporated into a specially formulated oil and water emulsion vehicle consisting of Ammonium lactate, Cetyl Alcohol, Cetearyl alcohol, Dimethicone, Disodium EDTA, Glycerin, Glyceryl Stearate, Methyl Paraben, Mineral Oil, PEG-100, Phenoxy Ethanol, Polysorbate-80, Propyl Paraben, Trolamine , Water

DESCRIPTION

Salicylic acid is the 2-hydroxy derivative of benzoic acid having the following structure:

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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 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 urinary metabolites after percutaneous absorption differ from those after oral salicylate administration; those derived from percutaneous absorption contain more salicylate glucuronides and less salicyluric and salicylic acid. Almost 95% of a single dose of salicylate is excreted within 24 hours of its entrance into the extracellular space. Fifty to eighty percent of salicylate is protein bound to albumin. Salicylates compete with the binding of several drugs and can modify the action of these drugs. By similar competitive mechanisms other drugs can influence the serum levels of salicylate. (See PRECAUTIONS.)

I. Due to the competition of salicylate with other drugs for binding to serum albumin the following drug interactions may occur:

DRUG

DESCRIPTION OF INTERACTION

Sulfonylureas

Hypoglycemia potentiated.

Methotrexate

Decreases tubular reabsorption; clinical toxicity from methotrexate can result.

Oral Anticoagulants

Increased bleeding.

II. Drugs changing salicylate levels by altering renal tubular reabsorption:

DRUG

DESCRIPTION OF INTERACTION

Corticosteroids

Decreases plasma salicylate level; tapering doses of steroids may promote salicylism.

Acidifying Agents

Increases plasma salicylate levels.

Alkanizing Agents

Decreased plasma salicylate levels.

III. Drugs with complicated interactions with salicylates:

DRUG

DESCRIPTION OF INTERACTION

Heparin

Salicylate decreases platelet adhesiveness and interferes with hemostasis in heparin-treated patients.

Pyrazinamide

Inhibits pyrazinamide-induced hyperuricemia.

Uricosuric Agents

Effect of probenemide, sulfinpyrazone and phenylbutazone inhibited.

The following alterations of laboratory tests have been reported during salicylate therapy:

LABORATORY TESTS

EFFECT OF SALICYLATES

Thyroid Function

Decreased PBI; increased t3 uptake.

Urinary Sugar

False negative with glucose oxidase; false positive with

Clinitest with high-dose salicylate therapy (2-5g q.d.).

5-Hydroxyindole acetic acid

False negative with fluorometric test.

Acetone ketone bodies

False positive FeCI3 in Gerhardt reaction; red color persists with boiling.

17-OH

corticosteroids

False reduced values with >4.8g q.d. salicylate.

Vanilmandelic acid

False reduced values.

Uric Acid

May increase or decrease depending on dose.

Prothrombin

Decreased levels; slightly increased prothrombin time.

INDICATIONS AND USAGE

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.

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