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|CREAM||1 JAR in 1 BOX (42546-270-01) > 454 g in 1 JAR||Label Information|
Salicylic Acid 6% Cream contains 6% salicylic acid â€¨USP incorporated into a specially formulated oilâ€¨in water emulsion vehicle containing ammoniumâ€¨lactate, cetearyl alcohol, cetearyl alcohol andâ€¨PEG-3 distearoylamidoethylmonium methosulfateâ€¨and polysorbate 60, cetyl alcohol, dimethiconeâ€¨350, disodium EDTA, glycerine, glyceryl stearateâ€¨SE, methyl paraben, mineral oil, PEG-100 stearate,â€¨phenoxyethanol, propyl paraben, purified waterâ€¨and trolamine.â€¨Salicylic acid is the 2-hydroxy derivative of benzoicâ€¨acid having the following structure:â€¨â€¨This formulation has been shown to provide gradualâ€¨and prolonged release of the active ingredient into â€¨the skin.â€¨
Salicylic acid has been shown to produce â€¨desquamation of the horny layer of skin while not â€¨effecting qualitative or quantitative changes in theâ€¨structure of the viable epidermis. The mechanism of â€¨action has been attributed to a dissolution ofâ€¨ intercellular cement substance. In a study of theâ€¨percutaneous absorption of salicylic acid in a 6%â€¨ salicylic acid gel in four patients with extensiveâ€¨ active psoriasis, Taylor and Halprin showed that theâ€¨peak serum salicylate levels never exceeded 5â€¨mg/100 mL even though more than 60% of the â€¨applied salicylic acid was absorbed. Systemic toxicâ€¨reactions are usually associated with much higher â€¨serum levels (30 to 40 mg/100 mL). Peak serum â€¨levels occurred within five hours of the topicalâ€¨application under occlusion. The sites were â€¨occluded for 10 hours over the entire body surface â€¨below the neck. Since salicylates are distributed in â€¨the extracellular space, patients with a contracted â€¨extracellular space due to dehydration or diuretics â€¨have higher salicylate levels than those with aâ€¨normal extracellular space. (See PRECAUTIONS.)â€¨ The major metabolites identified in the urine after â€¨topical administration are salicyluric acid (52%),â€¨salicylate glucuronides (42%) and free salicylic acid â€¨(6%). The urinary metabolites after percutaneous â€¨absorption differ from those after oral salicylate â€¨administration; those derived from percutaneous â€¨absorption contain more salicylate glucuronides â€¨and less salicyluric and salicylic acid. Almost 95%â€¨ of a single dose of salicylate is excreted within 24â€¨ hours of its entrance into the extracellular space.â€¨ Fifty to eighty percent of salicylate is protein boundâ€¨ to albumin. Salicylates compete with the binding â€¨of several drugs and can modify the action of these â€¨drugs; by similar competitive mechanisms other â€¨drugs can influence the serum levels of salicylate. â€¨(See PRECAUTIONS.)
For Dermatologic Use: Salicylic Acid 6% Cream isâ€¨ a topical aid in the removal of excessive keratin in â€¨hyperkeratotic skin disorders, including verrucae,â€¨ and the various ichthyoses (vulgaris, sex-linkedâ€¨and lamellar), keratosis palmaris and plantaris, â€¨keratosis pilaris, pityriasis rubra pilaris, andâ€¨psoriasis (including body, scalp, palms and soles). â€¨For Podiatric Use: Salicylic Acid 6% Cream is a â€¨topical aid in the removal of excessive keratin onâ€¨dorsal and plantar hyperkeratotic lesions. Topical â€¨preparations of 6% salicylic acid have beenâ€¨ reported to be useful adjunctive therapy for verrucaeâ€¨plantares.
Prolonged and repeated daily use over large areas, â€¨especially in children and those patients with â€¨significant renal or hepatic impairment, could resultâ€¨in salicylism. Patients should be advised not to apply â€¨occlusive dressings, clothing or other occlusive topical â€¨products such as petrolatum-based ointments â€¨to prevent excessive systemic exposure to salicylic â€¨acid. Excessive application of the product other thanâ€¨ is needed to cover the affected area will not resultâ€¨in a more rapid therapeutic benefit. Concomitant use of other drugs which may contribute to elevatedâ€¨ serum salicylate levels should be avoided where theâ€¨ potential for toxicity is present. In children under 12â€¨ years of age and those patients with renal or hepaticâ€¨impairment, the area to be treated should be â€¨limited and the patient monitored closely for signs â€¨of salicylate toxicity: nausea, vomiting, dizziness,â€¨loss of hearing, tinnitus, lethargy, hyperpnea,â€¨ diarrhea, and psychic disturbances. In the eventâ€¨of salicylic acid toxicity, the use of Salicylic Acid â€¨6% Cream should be discontinued. Fluids should â€¨be administered to promote urinary excretion. Treatmentâ€¨ with sodium bicarbonate (oral or intravenous) â€¨should be instituted as appropriate. Patientsâ€¨ should be cautioned against the use of oral aspirin â€¨and other salicylate containing medications, such â€¨as sports injury creams, to avoid additional excessiveâ€¨ exposure to salicylic acid. Where needed, aspirin â€¨should be replaced by an alternative non-steroidalâ€¨anti-inflammatory agent that is not salicylate based. â€¨Due to potential risk of developing Reyeâ€™s syndrome, â€¨salicylate products should not be used in childrenâ€¨ and teenagers with varicella or influenza, unlessâ€¨ directed by a physician.
The following interactions are from a publishedâ€¨review and include reports concerning both oral andâ€¨topical salicylate administration. The relationship ofâ€¨these interactions to the use of Salicylic Acid 6%â€¨Cream is not known.
â€¨I. Due to the competition of salicylate with otherâ€¨drugs for binding to serum albumin the followingâ€¨drug interactions may occur:
â€¨DRUG DESCRIPTION OF INTERACTIONâ€¨
Sulfonylureas Hypoglycemia potentiated.
â€¨Methotrexate Decreases tubular reabsorption; clinical toxicity from methotrexate can result.â€¨
Oral Anticoagulants Increased bleeding.
II. Drugs changing salicylate levels by altering renalâ€¨tubular reabsorption:
â€¨DRUG DESCRIPTION OF INTERACTIONâ€¨
Corticosteroids Decreases plasma salicylate level; tapering doses of steroids may promote salicylism.â€¨
Acidifying Agents Increases plasmasalicylate level.â€¨
Alkalizing Agents Decreased plasma salicylate levels.
III. Drugs with complicated interactions withâ€¨salicylates:â€¨
DRUG DESCRIPTION OF INTERACTION
â€¨Heparin Salicylate decreases platelet adhesiveness and interferes with hemostasis in heparin-treated patients.â€¨
Pyrazinamide Inhibits pyrazinamideinduced hyperuricemia.â€¨
Uricosuric Agents Effect of probenemide, sulfinpyrazone and phenylbutazone inhibited.
The following alterations of laboratory tests haveâ€¨been reported during salicylate therapy:
â€¨LABORATORY TESTS EFFECT OF SALICYLATESâ€¨
Thyroid Function Decreased PBI; increased T3 uptake.â€¨
Urinary Sugar False negative with glucose oxidase; false positive with Clinitest with high-dose salicylate therapy (2-5g q.d.).
â€¨5-Hydroxyindole acetic acid False negative with fluorometric test.
Acetone, False positive FeCl3 in Gerhardt reaction; red color persists with boiling.â€¨ketone bodies
â€¨17-OH corticosteroids False reduced values with >4.8g q.d. salicylate.
â€¨â€¨Vanilmandelic acid False reduced values.
â€¨Uric acid May increase or decrease depending on dose.
â€¨Prothrombin Decreased levels; slightly increased prothrombin time.
Category C â€“ Salicylic acid has been shown to be â€¨teratogenic in rats and monkeys. It is difficult to extrapolate fromâ€¨ oral doses of acetylsalicylic acid used in these studies to topical â€¨administration as the oral dose to monkeys may represent six â€¨times the maximal daily human dose of salicylic acid whenâ€¨ applied topically over a large body surface. There are no adequateâ€¨ and well-controlled studies in pregnant women. Salicylic Acid 6%â€¨(w/w) Shampoo should be used during pregnancy only if the â€¨potential benefit justifies the potential risk to the fetus.
Salicylic acid has been shown to beâ€¨teratogenic in rats and monkeys. It is difficult to extrapolate fromâ€¨oral doses of acetylsalicylic acid used in these studies to topicalâ€¨administration as the oral dose to monkeys may represent sixâ€¨times the maximal daily human dose of salicylic acid whenâ€¨applied topically over a large body surface. There are no adequateâ€¨and well-controlled studies in pregnant women. Salicylic Acid 6%â€¨(w/w) Shampoo should be used during pregnancy only if theâ€¨potential benefit justifies the potential risk to the fetus.
The preferable method of use is to apply 6% Salicylic â€¨Acid Cream thoroughly to the affected area and to â€¨cover the treated area at night after washing andâ€¨ before retiring. Preferably, the skin should beâ€¨ hydrated for at least five minutes prior to application.â€¨The medication is washed off in the morning and if â€¨excessive drying and/or irritation is observed, a blandâ€¨ cream or lotion may be applied. Once clearing is â€¨apparent, the occasional use of Salicylic Acid 6%â€¨ Cream will usually maintain the remission. In those â€¨areas where occlusion is difficult or impossible,â€¨ application may be made more frequently; hydrationâ€¨by wet packs or baths prior to application apparentlyâ€¨ enhances the effect. (See WARNINGS.) Unless handsâ€¨ are being treated, hands should be rinsed thoroughly â€¨after application. Excessive repeated application of â€¨Salicylic Acid 6% Cream will not necessarily increaseâ€¨ its therapeutic benefit, but could result in increased â€¨local intolerance and systemic adverse effects suchâ€¨ as salicylism.
salicylic acid cream
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