and thoroughly Salex Shampoo Generic Name: salicylic acid Dosage Form: shampoo Overview Side Effects Dosage Professional Interactions More User Reviews Support Group Q & A 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 DERMATOLOGIC USE ONLY. NOT FOR OPHTHALMIC, ORAL OR INTRAVAGINAL USE. Salex Shampoo Description Salex Shampoo contains 6% w/w salicylic acid USP in a vehicle consisting of purified water, acrylates copolymer, sodium laureth sulfate, trolamine, quaternium 26 and propylene glycol, cocamidopropyl betaine, behentrimonium methosulfate and cetearyl alcohol, propylparaben, methylparaben, glycerin, disodium EDTA and chamomile tea fragrance. 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 Salex Shampoo - 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 Salex Shampoo For Dermatologic Use: Salex Shampoo 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: Salex Shampoo 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 Salex Shampoo should not be used in any patient known to be sensitive to salicylic acid or any other listed ingredients. Salex Shampoo should not be used in children under 2 years of age. Warnings Prolonged use over large areas, especially in children and those patients with significant renal or hepatic impairment could result in salicylism. Excessive application of the product other than is needed to cover the affected area will not result in a more 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 Salex 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 Salex 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. Alkalinizing 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. Salex Shampoo 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 Salex Shampoo, 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 Salex Shampoo. 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 . Salex Shampoo Dosage and Administration Wet hair and apply Salex Shampoo to the scalp. Work into a lather then rinse. Repeat the treatment as needed until the condition clears. Once clearing is apparent, the occasional use of Salex Shampoo will usually maintain the remission. How is Salex Shampoo Supplied Salex Shampoo is available in 6 fl. oz. (177 mL) bottle (NDC 13548-012-06). Store at controlled room temperature 20 to 25 C (68 to 77 F). Do not freeze. Distributed by: Valeant Pharmaceuticals North America LLC Bridgewater, NJ 08807 USA REORDER NO. Salex Shampoo: 13548-012-06 Salex is a trademark of Valeant Pharmaceuticals International, Inc. or its affiliates. Valeant Pharmaceuticals North America LLC 9492700 PRINCIPAL DISPLAY PANEL - 454 g Carton NDC 13548-012-06 Rx only Salex (6% w/w Salicylic Acid) Shampoo 6 fl. oz . (177mL) 9492500 VALEANT SALEX salicylic acid shampoo Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:13548-012 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Salicylic acid (Salicylic acid) Salicylic acid 60 mg in 1 mL Inactive Ingredients Ingredient Name Strength water SODIUM LAURETH-3 SULFATE Trolamine propylene glycol COCAMIDOPROPYL BETAINE behentrimonium methosulfate cetostearyl alcohol propylparaben methylparaben glycerin edetate disodium CHAMOMILE Packaging # Item Code Package Description 1 NDC:13548-012-06 177 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved drug other 10/01/2004 Labeler - Coria Laboratories (010977972) Establishment Name Address ID/FEI Operations Denison Pharmaceuticals, LLC 001207208 MANUFACTURE(13548-012) Revised: 11/2015 Coria Laboratories Next Interactions Print this page Add to My Med List More about Salex (salicylic acid topical) Side Effects Dosage Information Drug Interactions Support Group Pricing & Coupons En Español 0 Reviews Add your own review/rating Drug class: topical acne agents Consumer resources Salex Salex Topical (Advanced Reading) Professional resources Salex (FDA) Salicylic Acid (AHFS Monograph) Other brands: Salacyn , KeralytGel , Virasal , Keralyt Shampoo , ... +10 more Related treatment guides Acne Dermatological Disorders} 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 Manufacturer Valeant Pharmaceuticals International, Inc. 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 Dermatological Disorders triamcinolone , clobetasol topical , betamethasone , Temovate , Diprolene , Analpram-HC , Celestone , urea topical , Clobex , Valisone , More... Acne doxycycline , clindamycin topical , erythromycin topical , minocycline , tretinoin topical , tetracycline topical , dapsone topical , Accutane , Vibramycin , Retin-A , isotretinoin , More... Salex Rating No Reviews - Be the first! No Reviews - Be the first! Not Rated - Be the first!} } shade
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