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ALCORTIN A
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hydrocortisone acetate,
aloe vera leaf and
iodoquinol gel 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. ---------- ALCORTIN® A gelDESCRIPTIONEach gram of Alcortin® A contains 2.0% (20 mg) Hydrocortisone Acetate and 1.0% (10 mg) Iodoquinol. Also contains 1.0% (10 mg) Aloe polysaccharide1. Other ingredients: Purified Water, Carbopol, Magnesium Aluminum Silicate, PPG-20 Methyl Glucose Ether, Aminomethyl Propanol, Propylene Glycol, Glycerine, Benzyl Alcohol, SD Alcohol 40 B, Biopeptide, Hydrochloric Acid, FD&C Blue # 1 and FD&C Yellow # 10.
CLINICAL PHARMACOLOGYHydrocortisone Acetate has anti-inflammatory, antipruritic and vasoconstrictive properties. While the mechanism of anti-inflammatory activity is unclear, there is evidence to suggest that a recognizable correlation exists between vasoconstrictor potency and therapeutic efficacy in humans. Iodoquinol has both antifungal and antibacterial properties. PharmacokineticsThe extent of percutaneous absorption of topical steroids is determined by many factors including the vehicle, the integrity of the epidermal barrier and the use of occlusive dressings. Hydrocortisone acetate can be absorbed from normal intact skin. Inflammation and/or other inflammatory disease processes in the skin increase percutaneous absorption. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids. Once absorbed through the skin, hydrocortisone acetate is metabolized in the liver and most body tissue to hydrogenated and degraded forms such as tetrahydrocortisone and tetrahydrocortisol. These are excreted in the urine, mainly conjugated as glucuronides, together with a very small proportion of unchanged hydrocortisone acetate. There are no data available regarding the percutaneous absorption of iodoquinol; however, following oral administration, 3-5% of the dose was recovered in the urine as a glucuronide. INDICATIONS AND USAGEBased on a review of a related drug by the National Research Council and subsequent FDA classification for that drug, the indications are as follows: "Possibly" Effective: Contact or atopic dermatitis; impetiginized eczema; nummular eczema; endogenous chronic infectious dermatitis; stasis dermatitis; pyoderma; nuchal eczema and chronic eczematoid otitis externa; acne urticata; localized or disseminated neurodermatitis; lichen simplex chronicus; anogenital pruritus (vulvae, scroti, ani); folliculitis; bacterial dermatoses; mycotic dermatoses such as tinea (capitis, cruris, corporis, pedis); monliasis; intertrigo. Final classification of the less-than-effective indications requires further investigation. CONTRAINDICATIONSAlcortin A is contraindicated in those patients with a history of hypersensitivity to hydrocortisone acetate, iodoquinol, aloe vera, glycine, histidine, lysine, palmitic acid or any other components of the preparation. WARNINGS AND PRECAUTIONSFor external use only. Keep away from eyes. If irritation develops, the use of Alcortin A should be discontinued and appropriate therapy instituted. Staining of the skin, hair and fabrics may occur. Not intended for use on infants or under diapers or occlusive dressings. If extensive areas are treated or if the occlusive dressing technique is used, the possibility exists of increased systemic absorption of the corticosteroid, and suitable precautions should be taken. Children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity. Parents of pediatric patients should be advised not to use tight-fitting diapers or plastic pants on a child being treated in the diaper area, as these garments may constitute occlusive dressings. Iodoquinol may be absorbed through the skin and interfere with thyroid function tests. If such tests are contemplated, wait at least one month after discontinuance of therapy to perform these tests. The ferric chloride test for phenylketonuria (PKU) can yield a false positive result if iodoquinol is present in the diaper or urine. Prolonged use may result in overgrowth of non-susceptible organisms requiring appropriate therapy. Keep out of reach of children. Burning, itching, irritation and dryness have been reported infrequently following the use of topical corticosteroids. Carcinogenesis, Mutagenisis and Impairment of FertilityLong term animal studies have not been performed to evaluate the carcinogenic potential of the effect on fertility of hydrocortisone or iodoquinol. In vitro studies to determine mutagenicity with hydrocortisone have revealed negative results. Mutagenicity studies have not been performed with iodoquinol. ADVERSE REACTIONSThe following local adverse reactions are reported infrequently with topical corticosteroids. These reactions are listed in an approximate decreasing order of occurrence. Burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infections, skin atrophy, striae and miliaria. DOSAGE AND ADMINISTRATIONApply to affected area 3-4 times daily in accordance with physician's directions or as directed otherwise by a physician. HOW SUPPLIEDRx only Distributed by: Manufactured by: © 2007 Primus Pharmaceuticals, Inc. All rights reserved. PRINCIPAL DISPLAY PANEL - 24 Pack CartonNDC 68040-705-13 Alcortin® A Gel Anti-fungal • Anti-bacterial • Anti-inflammatory 24 Hygienic • Convenient Contains moisturizers • For dermatological use only Biopeptide Aloe Complex™ Net Wt. 48.0 g (1.69 oz.) • 24 packs of 2.0g (0.07 oz.) each Each pack contains multiple doses 
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