Data from FDA - Curated by EPG Health - Last updated 27 July 2017

Indication(s)

INDICATIONS AND USAGE FOR DERMATOLOGIC USE SALACYN™ 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 SALACYN™ 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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Advisory information

contraindications
CONTRAINDICATIONS SALACYN™ 6% should not be used in any patient known to be sensitive to salicylic acid or any other listed ingredients. SALACYN™ 6% should not be used in children under 2 years of age.
Special warnings and precautions
PRECAUTIONS For external use only. Avoid contact with eyes and other mucous membranes. 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 SALACYN™ 6% is not known. Due to the competition of salicylate with other drugs for binding to the serum albumin the following drug interactions may occur: DRUG DISCRIPTION OF INTERACTION Sulfonylureas Hypoglycemia potentiated Methotrexate Decreases tubular reabsorption; clinical toxicity from methotrexate can result. Oral Anticoagulants Increased bleeding Drugs changing salicylate levels by altering renal tubular reabsorption: DRUG DISCRIPTION OF INTERACTION Corticosteroids Decreases plasma salicylate level; tapering doses of steroids may promote salicylism. Acidifying agents Increases plasma salicylate levels. Alkcanizing agents Decreased plasma salicylate levels. Drugs with completed interactions with salicylates: DRUG DISCRIPTION OF INTERACTION Heparin Salicylate decreases platelet adhesiveness and inteferes 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 FeCl3 in Gerhardt reaction; red color persist 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. PREGNANCY (Category C) Salicylic acid has been shown to be teratogenic in rats and monkeys. It is difficult to extrapolate from oral doses of acetylsalicylic acid used in these studies to topical administration as the oral does to monkeys may represent six times the maximal daily human does of salicylic acid when applied topically over a large body surface. There are no adequate and well-controlled studies in pregnant women. SALACYN™ 6% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. NURSING MOTHERS Because of the potential for serious adverse reactions in nursing infants from the mother's use of SALACYN™ 6%, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother. If used by nursing mothers, it should not be used on the chest area to avoid accidental contamination of the child. CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY No data are available concerning potential carcinogenic or reproductive effects of SALACYN™ 6%. It has been shown to lack mutagenic potential in the Ames Salmonella test.
Adverse reactions
ADVERSE REACTIONS Excessive erythema and scaling conceivably could result from the use on open skin lesions.

Usage information

Dosing and administration
DOSAGE AND ADMINISTRATION The preferable method of use is to apply SALACYN™ 6% 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 at 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 SALACYN™ 6% will usually maintain the remission. In those areas where occulsion 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 SALACYN™ 6% will not necessarily increase its therapeutic benefit, but could result in increased local intolerance and systemic adverse effects such as salicylism.
Pregnancy and lactation
NURSING MOTHERS Because of the potential for serious adverse reactions in nursing infants from the mother's use of SALACYN™ 6%, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother. If used by nursing mothers, it should not be used on the chest area to avoid accidental contamination of the child.

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 SALACYN™ 6% is not known. Due to the competition of salicylate with other drugs for binding to the serum albumin the following drug interactions may occur: DRUG DISCRIPTION OF INTERACTION Sulfonylureas Hypoglycemia potentiated Methotrexate Decreases tubular reabsorption; clinical toxicity from methotrexate can result. Oral Anticoagulants Increased bleeding Drugs changing salicylate levels by altering renal tubular reabsorption: DRUG DISCRIPTION OF INTERACTION Corticosteroids Decreases plasma salicylate level; tapering doses of steroids may promote salicylism. Acidifying agents Increases plasma salicylate levels. Alkcanizing agents Decreased plasma salicylate levels. Drugs with completed interactions with salicylates: DRUG DISCRIPTION OF INTERACTION Heparin Salicylate decreases platelet adhesiveness and inteferes with hemostasis in heparin treated patients. Pyrazinamide Inhibits pyrazinamide induced hyperuricemia. Uricosuric Agents Effect of probenemide, sulfinpyrazone and phenylbutazone inhibited.

More information

Category Value
Agency product number O414PZ4LPZ
Orphan designation No
Product NDC 58980-631,58980-630
Date Last Revised 11-11-2010
Type HUMAN PRESCRIPTION DRUG
RXCUI 422998
Storage and handling Store at controlled room temperature 20° - 25°C (68° - 77°F). Do not freeze.
Marketing authorisation holder Stratus Pharamceuticals, Inc