SALYCIM 60 mg/g

SALICYLIC ACID · CREAM · PURETEK CORPORATION

No Recall History

Plain English

SALYCIM is a cream containing salicylic acid at 60 mg/g, taken topical. Manufactured by PURETEK CORPORATION.

Key Facts

Brand Name: SALYCIM
Generic Name: SALICYLIC ACID
NDC Code (Product): 59088-227
Manufacturer: PURETEK CORPORATION
Strength: 60 mg/g
Dosage Form: CREAM
Route: TOPICAL
Marketing Status
Marketing Start: 12/06/2023

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

vomiting199 reports

pruritus196 reports

condition aggravated182 reports

headache180 reports

weight decreased173 reports

drug ineffective172 reports

infection172 reports

hypertension171 reports

urticaria168 reports

weight increased167 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

INDICATIONS AND USAGE For Dermatologic Use: Salycim™ 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: Salycim™ Cream 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.

Dosage & Administration

DOSAGE AND ADMINISTRATION The preferable method of use is to apply Salycim™ Cream thoroughly to the affected area and to cover the treated area at night after washing and before retiring. Preferably, the skin should be hydrated for a least five minutes prior to application. The medication is washed off in the morning and if excessive drying and/or irritation is observed, a bland cream or lotion may be applied. Once clearing is apparent, the occasional use of Salycim™ Cream will usually maintain the remission. In those areas where occlusion is difficult or impossible, application may be made more frequently; hydration by wet packs or baths prior to application apparently enhances the effect. (See WARNINGS .) Unless hands are being treated, hands should be rinsed thoroughly after application. Excessive repeated application of Salycim™ Cream will not necessarily increase its therapeutic benefit, but could result in increased local intolerance and systemic adverse effects such as salicylism.

Warnings

WARNINGS 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, hyperpnea, diarrhea, and psychic disturbances. In the event of salicylic acid toxicity, the use of Salycim™ Cream should be discontinued. Fluids should be administered topromote urinary excretion. Treatment with sodium bicarbonate (oral or intravenous) should be instituted as appropriate. Patients should be cautioned against the use of oral aspirin and other salicylate containing medications, such as sports injury creams, to avoid additional excessive exposure to salicylic acid. Where needed, aspirin should be replaced by an alternative non-steroidal anti-inflammatory agent that is not salicylate based. Patients should be …

Contraindications

CONTRAINDICATIONS Salycim™ Cream should not be used in any patient known to be sensitive to salicylic acid or any other listed ingredients. Salycim™ Cream should not be used in children under 2 years of age.

Drug Interactions

DRUG INTERACTIONS The following interactions are from a published review and include reports concerning both oral and topical salicylate administration. The relationship of these interactions to the use of Salycim™ Cream is not known. 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, sulfinpyraz…

Adverse Reactions

ADVERSE REACTIONS Excessive erythema and scaling conceivably could result from use on open skin lesions. Call your physician for medical advice about side effects.

Frequently Asked Questions

What is SALYCIM used for?

SALYCIM contains SALICYLIC ACID. It is a cream taken topical. Consult your doctor for specific uses.

Is SALYCIM a controlled substance?

SALYCIM is not classified as a controlled substance by the DEA.

What is the generic name for SALYCIM?

The generic name for SALYCIM is SALICYLIC ACID. There are 12 other brand versions of SALICYLIC ACID.

What is the NDC code for SALYCIM 60 mg/g?

The NDC (National Drug Code) for SALYCIM 60 mg/g is 59088-227, listed by PURETEK CORPORATION.

Product NDC

59088-227

Package NDC

59088-227-05

Other Salicylic Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)