Wart Remove 5-FU Ointment

Overview of Wart Remove 5-FU Ointment

Dosage Strength of Wart Remove 5-FU Ointment

Fluorouracil / Salicylic Acid 2.5/17% 5 mL Pump

General Information

Salicylic Acid

Salicylic acid is a topical keratolytic agent. It is used to remove excess keratin in hyperkeratotic skin disorders such as common and plantar warts, psoriasis, seborrheic dermatitis, calluses, and corns. Salicylic acid also is used to treat acne. Salicylic acid works by causing desquamation of the horny layer of skin. Prolonged or repeated daily use over large areas of skin may result in salicylism, especially in children and patients with renal or hepatic impairment. This drug was approved by the FDA in 1939.12345678

Mechanism of Action

Salicylic Acid

Salicylic acid exhibits keratolytic action by dissolution of intercellular cement substance causing desquamation of the horny layer of skin.569

Pharmacokinetics

Salicylic Acid

Following topical application, percutaneous absorption of salicylic acid does occur; however, systemic exposure is considered negligible with normal prescription use. Roughly 10% of applied salicylates can remain in the skin after dermal application; however, acute toxicity via dermal exposure is rarely seen for salicylic acid. Salicylism has occurred using high concentrations of salicylic acid on widespread areas of hyperkeratotic skin, but cases resulting from topically applied salicylic acid cosmetic or acne products have not been reported.10

Contraindications/Precautions

Salicylic Acid

Salicylic acid preparations are contraindicated in patients who have previously exhibited salicylate hypersensitivity.5 6 9

Topical salicylic acid preparations in concentrations greater than 6% are contraindicated in patients with diabetes mellitus and other conditions of poor blood circulation such as peripheral vascular disease. Do not use these preparations on moles, birthmarks, warts with hair growing from them, genital warts, or warts on the face or mucous membranes.311 4

Prolonged use of salicylic acid over large areas, especially in children and patients with renal impairment or hepatic disease may increase the risk for development of salicylism. In such patients, limit the treated area and closely monitor the patient for signs of salicylate toxicity such as nausea, vomiting, dizziness, loss of hearing, tinnitus, lethargy, hyperpnoea, diarrhea, and psychic disturbances. When the potential for toxicity is present, advise patients not to apply occlusive dressings, clothing or other occlusive topical products such as petrolatum-based ointments to prevent excessive systemic exposure to salicylic acid. Concomitant use of other drugs which may contribute to elevated serum salicylate levels (e.g., oral aspirin and other salicylate containing medications, such as sports injury creams) should be avoided. Discontinue use of salicylic acid if salicylic acid toxicity occurs and treat appropriately.5 6 9

The potential for Reye's syndrome should be considered with administration of salicylic acid products in children and adolescents with varicella or influenza.5 6 9

Avoid accidental exposure of salicylic acid products to the eyes, lips, mucus membranes and inflamed or broken skin as increased absorption may occur. If unintended mucus membrane or ocular exposure occurs, thoroughly rinse affected areas with water.5 6 9

Pregnancy

Salicylic Acid

There are no adequate and well-controlled studies in pregnant women. Salicylic acid products should only be used during pregnancy if the potential benefit to the mother outweighs the potential risk to the fetus.5 6 9 7 8

Breast-feeding

Salicylic Acid

It is not known whether topically applied salicylic acid is excreted into breast milk. According to the manufacturer, salicylic acid should not be used during breast-feeding. However, if the drug is used by nursing mothers, care should be taken to avoid application to the skin of the breast during lactation; oral ingestion by the infant could be harmful.5 6 9 Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally administered drug, healthcare providers are encouraged to report the adverse effect to the FDA.

Adverse Reactions/Side Effects

Salicylic Acid

Prolonged and repeated daily use over large areas, especially in children and patients with significant renal or hepatic impairment increases the potential for development of salicylism. 569

Topical application of salicylic acid is generally well tolerated, but may result in skin irritation including transient stinging, burning, or pruritus. Excessive erythema, peeling of the skin, and scaling may also occur, particularly if used on open skin lesions. Advise patients to discontinue use and consult a physician if excessive burning, stinging, or peeling occurs.5 6 9

Topical over-the-counter (OTC) acne products, including salicylic acid, have been associated with rare but serious and potentially life-threatening hypersensitivity reactions. These reactions may occur within minutes to a day or longer after use of the product. Instruct patients to stop using topical acne products if they experience signs of anaphylactoid reactions such as throat tightness; difficulty breathing; feeling faint; or swelling of the eyes, face, lips, or tongue. The product should also be discontinued in patients who develop urticaria or pruritus. Based on the information reported to the FDA, it is uncertain whether the reactions are caused by the active ingredients benzoyl peroxide or salicylic acid, the inactive ingredients or a combination of both. When initiating therapy with an OTC topical acne product, advise patients to apply a small amount to one or two small affected areas for 3 days and monitor for signs of a hypersensitivity reaction. If no discomfort occurs, the instructions on the Drug Facts label may be followed.12

Storage

Store this medication in its original container at 68°F to 77°F (20°C to 25°C) and away from heat, moisture and light. Keep all medicine out of the reach of children. Throw away any unused medicine after the beyond use date. Do not flush unused medications or pour down a sink or drain.

  • 1. Compound W (salicylic acid 17%) package insert. Tarrytown, NY: Prestige Brands; 2013 Mar.
  • 2. Compound W gel (salicylic acid 17% gel) package insert. Tarrytown, NY: Prestige Brands; 2013 April.
  • 3. a. b. Hydrisalic gel (salicylic acid 17%) package insert. Farmingdale, NY: Pedinol Pharmacal Inc.; 2011 Nov.
  • 4. a. b. Virasal (salicylic acid 27.5%) package insert. Vernon Hills, IL: Elorac, Inc.; 2011 Jan.
  • 5. a. b. c. d. e. f. g. h. i. j. Salex 6% (salicylic acid) cream and lotion package insert. Bridgewater, NJ: Valeant Pharmaceuticals North America LLC; 2019 Jan.
  • 6. a. b. c. d. e. f. g. h. i. j. Salacyn 6% (salicylic acid 6%) cream or lotion package insert. Miami, Fl: Stratus Pharmaceuticals Inc.; 2010 Nov..
  • 7. a. b. Salitech (salicylic acid 5% lotion) package insert. Peoria, AZ: Solutech Pharmaceuticals; 2016 Dec.
  • 8. a. b. Salisol (salicylic acid 23% topical solution) package insert. Peoria, AZ: Solutech Pharmaceuticals; 2016 Dec.
  • 9. a. b. c. d. e. f. g. h. i. Salvax 6% foam (salicylic acid) package insert. Newtown, PA: Quinnova Pharmaceuticals, Inc.; 2009 Apr.
  • 10. Cosmetic Ingredient Review Expert Panel. Safety assessment of Salicylic Acid, Butyloctyl Salicylate, Calcium Salicylate, C12-15 Alkyl Salicylate, Capryloyl Salicylic Acid, Hexyldodecyl Salicylate, Isocetyl Salicylate, Isodecyl Salicylate, Magnesium Salicylate, MEA-Salicylate, Ethylhexyl Salicylate, Potassium Salicylate, Methyl Salicylate, Myristyl Salicylate, Sodium Salicylate, TEA-Salicylate, and Tridecyl Salicylate. Int J Toxicol 2003;22 (Suppl 3):1-108. Review.
  • 11. Curad mediplast (salicylic acid 40%) package insert. Mundelein, IL: Medline Industries, Inc.; 2013 Feb.
  • 12. Food and Drug Administration MedWatch. Over-The-Counter Topical Acne Products: Drug Safety Communication - Rare But Serious Hypersensitivity Reactions. Retrieved June 25, 2014. Available on the World Wide Web http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm402722.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

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