Salicylic Acid

Exact-Rx, Inc.

Rx Only

FULL PRESCRIBING INFORMATION: CONTENTS*

• SALICYLIC ACID DESCRIPTION
• CLINICAL PHARMACOLOGY
• SALICYLIC ACID INDICATIONS AND USAGE
• SALICYLIC ACID CONTRAINDICATIONS
• WARNINGS AND PRECAUTIONS
• DRUG INTERACTIONS
• Pregnancy
• Nursing Mothers
• NON CLINICAL TOXICOLOGY
  • Carcinogenesis, Mutagenesis, Impairment of Fertility
• SALICYLIC ACID ADVERSE REACTIONS
• OVERDOSAGE
• SALICYLIC ACID DOSAGE AND ADMINISTRATION
• HOW SUPPLIED/STORAGE AND HANDLING
• PRINCIPAL DISPLAY PANEL

FULL PRESCRIBING INFORMATION

FOR DERMATOLOGICAL USE ONLY. NOT
FOR OPHTHALMIC, ORAL OR
INTRAVAGINAL USE.

SALICYLIC ACID DESCRIPTION

6% Salicylic Acid Gel is a gel for topical administration containing 6% salicylic acid in a vehicle composed of disodium EDTA, hydroxyethyl cellulose, propylene glycol, purified water, SD alcohol 40-2.

CLINICAL PHARMACOLOGY

Salicylic acid is a keratolytic that has been shown to produce desquamation of the stratum corneum of the skin while not effecting qualitative or quantitative changes in the structure of the viable epidermis. The exact mechanism of action is unknown, however, it has been attributed to the dissolution of intercellular adhesions. While topical administration can lead to systemic absorption, systemic toxic reactions are usually associated with much higher serum concentrations (30 to 40 mg/100 ml). Occlusion can lead to higher systemic absorption.

Almost 95% of a single dose of salicylate is excreted within 24 hours of its entrance into the extracellular space. 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 glucuronides and less salicyluric and salicylic acid. (See PRECAUTIONS .)

SALICYLIC ACID INDICATIONS AND USAGE

For the removal of excess keratin in hyperkeratotic disorders, including scaling associated with psoriasis or thickened skin of palms and soles, corns and calluses.

CONTRAINDICATIONS

6% Salicylic Acid Gel should not be used in any patient known to be sensitive to salicylic acid or any other listed ingredient. 6% Salicylic Acid Gel should not be used on children under 2 years of age.

WARNINGS AND PRECAUTIONS

Prolonged use over large areas, especially in children and those patients with significant renal or hepatic impairment, could result in salicylism. Concomitant use of other drugs which may contribute to elevated serum salicylate levels should be avoided where the potential for toxicity is present. In children under 12 years of age and those patients with renal or hepatic impairment, the area to be treated should be limited and the patient monitored closely for signs of salicylate toxicity: nausea, vomiting, dizziness, loss of hearing, tinnitus, lethargy, hyperpnoea, diarrhea, psychic disturbances. In the event of salicylic acid toxicity, the use of 6% Salicylic Acid Gel should be discontinued. Fluids should be administered to promote urinary excretion. Treatment with sodium bicarbonate (oral or intravenous) should be instituted as appropriate. Considering the potential risk of developing Reye's Syndrome, salicylate products should not be administered to children or teenagers with varicella or influenza, unless directed by a physician.

For external use only. Not for ophthalmic, oral, or intravaginal use. Avoid contact with eyes and other mucous membranes. Mild burning or stinging may occur. Peeling of the skin may increase as the salicylic acid works to loosen excess keratin. If excessive burning, stinging or peeling occurs, discontinue use and consult your physician.

FLAMMABLE. Keep away from heat and open flame. Keep this and all medications out of reach of children.

DRUG INTERACTIONS

Salicylates compete with the binding of several drugs and can modify the action of these drugs. Due to the competition of salicylate with other drugs for binding to serum albumin, the following drug interactions may occur:

Tolbutamide, Sulfonylureas—Can potentiate hypoglycemia.
Methotrexate—Decreases tubular reabsorption.
Oral Anticoagulants—Increases bleeding.
Corticosteroids—Decreases plasma salicylate level; tapering doses of steroids may promote salicylism.
Ammonium Sulfate—Increases plasma salicylate level.
Heparin Salicylate—Decreases platelet adhesiveness and interferes with hemostasis in heparin-treated patients.
Pyrazinamide—Inhibits pyrazinamide-induced hyperuricemia.
Uricosuric Agents—Effect of probenecid, sulfinpyrazone and phenylbutazone inhibited.

Pregnancy

There are no adequate and well-controlled studies in pregnant women. 6% Salicylic Acid Gel should be used during pregnancy only if the potential benefit justifies the risk to the fetus.

Nursing Mothers

Because of the potential for serious adverse reactions in nursing infants from the mother's use of 6% Salicylic Acid Gel, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

NON CLINICAL TOXICOLOGY

Carcinogenesis, Mutagenesis, Impairment of Fertility

No data is available concerning potential carcinogenic or reproductive effects of 6% Salicylic Acid Gel. It has been shown to lack mutagenic potential in the Ames Test.

SALICYLIC ACID ADVERSE REACTIONS

Excessive erythema and scaling could conceivably result from use on open skin lesions.

Call your doctor for medical advice about side effects.

OVERDOSAGE

In cases of suspected salicylate toxicity, the use of 6% Salicylic Acid Gel should be discontinued, and the patient should be monitored closely for signs of: nausea, vomiting, dizziness, loss of hearing, tinnitus, lethargy, hyperpnoea, diarrhea, psychic disturbances. Call your local poison control center and/or your doctor if overdosage is suspected.

SALICYLIC ACID DOSAGE AND ADMINISTRATION

Apply 6% Salicylic Acid Gel thoroughly to the affected area and cover the area at night. Preferably, the skin should be soaked in water for at least five minutes prior to application. Wash medication off in the morning. In those areas where occlusion is difficult or impossible, more frequent application may be necessary. Once clearing is apparent, occasional use of 6% Salicylic Acid Gel will usually help maintain the remission. Hands should be rinsed thoroughly after application, unless hands are being treated.

HOW SUPPLIED/STORAGE AND HANDLING

6% Salicylic Acid Gel is supplied in a 40 g tube of translucent gel, NDC 42808-0300-40.

Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F). See USP Controlled Room Temperature.

Protect from freezing.

Manufactured in the U.S.A. for Exact-Rx, Inc., Melville, NY 11747

00-0300-40-205-00

Iss:5/11

PRINCIPAL DISPLAY PANEL

For External Use Only

NDC 42808-0300-40        Rx Only

Salicylic
Acid

6%

GEL

Exact-Rx.
INCORPORATED

Net Wt. 1.41 oz. (40 g)