trekking Salicylic Acid Lotion Dosage Form: lotion Overview Side Effects Dosage Professional Interactions More User Reviews Support Group Q & A Compare Alternatives Pricing & Coupons Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here. Rx Only FOR DERMATOLOGICAL USE ONLY. NOT FOR OPHTHALMIC, ORAL OR INTRAVAGINAL USE. Salicylic Acid Lotion Description Salicylic Acid Cream, 6% contains 6% salicylic acid USP incorporated into an emulsion vehicle consisting of ammonium lactate, behentrimonium chloride and isopropyl alcohol, cetyl alcohol, dimethicone 350, disodium EDTA, glycerin, glyceryl stearate SE, methylparaben, mineral oil, PEG-100 stearate, phenoxyethanol, propylparaben, purified water, stearyl alcohol and trolamine. Salicylic Acid Lotion, 6% contains 6% w/w salicylic acid USP incorporated into an emulsion vehicle consisting of ammonium lactate, behentrimonium chloride and isopropyl alcohol, cetyl alcohol, dimethicone 350, disodium EDTA, glycerin, glyceryl stearate SE, methylparaben, mineral oil, PEG-100 stearate, propylparaben, purified water, stearyl alcohol and trolamine. Salicylic acid is the 2-hydroxy derivative of benzoic acid having the following structure: Slideshow Newborn Baby Health: 8 Woes From Cradle Cap And Colic To Whooping Cough Salicylic Acid Lotion - Clinical Pharmacology Salicylic acid has been shown to produce desquamation of the horny layer of skin while not effecting qualitative or quantitative changes in the structure of the viable epidermis. The mechanism of action has been attributed to a dissolution of intercellular cement substance. In a study of the percutaneous absorption of salicylic acid in a 6% salicylic acid gel in four patients with extensive active psoriasis, Taylor and Halprin showed that the peak serum salicylate levels never exceeded 5 mg/100 ml even though more than 60% of the applied salicylic acid was absorbed. Systemic toxic reactions are usually associated with much higher serum levels (30 to 40 mg/100 ml). Peak serum levels occurred within five hours of the topical application under occlusion. The sites were occluded for 10 hours over the entire body surface below the neck. Since salicylates are distributed in the extracellular space, patients with a contracted extracellular space due to dehydration or diuretics have higher salicylate levels than those with a normal extracellular space. (See PRECAUTIONS .) 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 salicylate glucuronides and less salicyluric and salicylic acid. Almost 95% of a single dose of salicylate is excreted within 24 hours of its entrance into the extracellular space. Fifty to eighty percent of salicylate is protein bound to albumin. Salicylates compete with the binding of several drugs and can modify the action of these drugs; by similar competitive mechanisms other drugs can influence the serum levels of salicylate. (See PRECAUTIONS .) Indications and Usage for Salicylic Acid Lotion For Dermatologic Use: Salicylic Acid 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: Salicylic Acid 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. Contraindications Salicylic Acid should not be used in any patient known to be sensitive to salicylic acid or any other listed ingredients. Salicylic Acid should not be used in children under 2 years of age. Warnings Prolonged and repeated daily use over large areas, especially in children and those patients with significant renal or hepatic impairment, could result in salicylism. Patients should be advised not to apply occlusive dressings, clothing or other occlusive topical products such as petrolatumbased ointments to prevent excessive systemic exposure to salicylic acid. Excessive application of the product other than is needed to cover the affected area will not result in a more rapid therapeutic benefit. 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 Salicylic Acid should be discontinued. Fluids should be administered to promote 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. Due to potential risk of developing Reye s syndrome, salicylate products should not be used in children and teenagers with varicella or influenza, unless directed by a physician. 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 Salicylic Acid 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 level. 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, 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 T 3 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 FeCl 3 in Gerhardt reaction; red color persists 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 dose to monkeys may represent six times the maximal daily human dose of salicylic acid when applied topically over a large body surface. There are no adequate and well-controlled studies in pregnant women. Salicylic Acid 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 Salicylic Acid, 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. If used by nursing mothers, it should not be used on the chest area to avoid the accidental contamination of the child. Carcinogenesis, Mutagenesis, Impairment of Fertility No data are available concerning potential carcinogenic or reproductive effects of Salicylic Acid has been shown to lack mutagenic potential in the Ames Salmonella test. Adverse Reactions Excessive erythema and scaling conceivably could result from use on open skin lesions. Overdosage See Warnings. Salicylic Acid Lotion Dosage and Administration The preferable method of use is to apply Salicylic Acid 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 Salicylic Acid 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 Salicylic Acid will not necessarily increase its therapeutic benefit, but could result in increased local intolerance and systemic adverse effects such as salicylism. How is Salicylic Acid Lotion Supplied Salicylic Acid Cream, 6% is available in 400g (NDC 45802- 806 -01) bottles. Salicylic Acid Lotion, 6% is available in 14 fl oz (414 ml) (NDC 45802- 818 -41) bottles. Store at controlled room temperature 20 - 25 C (68 - 77 F). Do not freeze. MADE IN ISRAEL MANUFACTURED BY PERRIGO YERUHAM, ISRAEL 80500 : 5C200 RC J1 PACKAGE/LABEL PRINCIPAL DISPLAY PANEL Salicylic Acid Lotion, 6% Rx Only Salicylic Acid Lotion, 6% Front Label Salicylic Acid Lotion, 6% Front Label Salicylic Acid Lotion, 6% Back Label PACKAGE/LABEL PRINCIPAL DISPLAY PANEL Salicylic Acid Cream, 6% Rx Only Salicylic Acid Cream, 6% Front Label Image Salicylic Acid Cream, 6% Front Label Image Salicylic Acid Cream, 6% Back Label Image SALICYLIC ACID Salicylic Acid Lotion Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:45802-818 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALICYLIC ACID (SALICYLIC ACID) SALICYLIC ACID 6 mg in 100 mL Inactive Ingredients Ingredient Name Strength AMMONIUM LACTATE BEHENTRIMONIUM CHLORIDE ISOPROPYL ALCOHOL CETYL ALCOHOL DIMETHICONE 350 EDETATE DISODIUM GLYCERIN GLYCERYL MONOSTEARATE METHYLPARABEN MINERAL OIL PEG-100 STEARATE PROPYLPARABEN WATER STEARYL ALCOHOL TROLAMINE Packaging # Item Code Package Description 1 NDC:45802-818-41 414 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved drug other 09/27/2007 01/01/2019 SALICYLIC ACID salicylic acid cream Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:45802-806 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALICYLIC ACID (SALICYLIC ACID) SALICYLIC ACID 6 g in 100 g Inactive Ingredients Ingredient Name Strength AMMONIUM LACTATE BEHENTRIMONIUM CHLORIDE ISOPROPYL ALCOHOL CETYL ALCOHOL DIMETHICONE 350 EDETATE DISODIUM GLYCERIN GLYCERYL STEARATE SE METHYLPARABEN MINERAL OIL PEG-100 STEARATE PHENOXYETHANOL PROPYLPARABEN WATER STEARYL ALCOHOL TROLAMINE Packaging # Item Code Package Description 1 NDC:45802-806-01 400 g in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved drug other 09/07/2007 06/01/2018 Labeler - Perrigo New York Inc (078846912) Revised: 09/2017 Perrigo New York Inc Next Interactions Print this page Add to My Med List More about salicylic acid topical Side Effects Dosage Information Drug Interactions Compare Alternatives Support Group Pricing & Coupons En Español 7 Reviews Add your own review/rating Drug class: topical acne agents Consumer resources Salicylic acid topical ... +12 more Professional resources Salicylic Acid (AHFS Monograph) Salicylic Acid (FDA) Salicylic Acid Foam (FDA) Salicylic Acid Gel (FDA) Salicylic Acid Liquid (FDA) ... +3 more Other brands: Salacyn , KeralytGel , Virasal , Keralyt Shampoo , ... +11 more Related treatment guides Dermatological Disorders Warts Acne Dandruff} FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Drug Status Rx OTC Availability Rx and/or OTC C Pregnancy Category Risk cannot be ruled out N/A CSA Schedule Not a controlled drug Manufacturers Perrigo Company Acella Pharmaceuticals, LLC Drug Class Topical acne agents Topical keratolytics Related Drugs topical acne agents clindamycin topical , erythromycin topical , tretinoin topical , tetracycline topical , dapsone topical , Finacea topical keratolytics salicylic acid topical , Compound W , Condylox , Duofilm Warts salicylic acid topical , Compound W , Duofilm , silver nitrate topical , Virasal , More... Dermatological Disorders triamcinolone , clobetasol topical , betamethasone , Temovate , Diprolene , More... Acne doxycycline , clindamycin topical , erythromycin topical , minocycline , tretinoin topical , tetracycline topical , More... 1 more conditions... Salicylic acid topical Rating 7 User Reviews 8.3 /10 7 User Reviews 8.3 Rate it!} } substantial
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