PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.
Alcortin 2.0 ucarton.jpg. NDC 68040-702-13 Rx onlyAlcortinAnti-fungalAnti-bacterialAnti-inflammatory1% Iodoquinol 2% Hydrocortisone See product literature for complete information. TO OPEN SINGLE PACK: Tear at notch along dotted line on front of package. DOSAGE: Apply to affected area 3-4 times daily or as directed by your physician. CONTENTS: This carton contains 24 single packs of 2.0 grams each of Alcortin gel. Each gram ofAlcortin contains 2.0% (20 mg) Hydrocortisone and 1.0% (10 mg) lodoquinol. Also contains 1.0%(10 mg) Aloe polysaccharide and 5.0% (50 mg) Biopeptide combination of Palmitoyl oligopeptide,Polyglyceryl methacrylate and Propylene glycol. Other ingredients: Aminomethyl propanol, Benzylalcohol, Blue 1, Carbomer, Fragrance, Glycerin, Magnesium aluminum silicate, PPG-20 methylglucose ether, Propylene glycol, Purified water, SO alcohol 40-B and Yellow 10. WARNING: Keep out of reach of children. Not for use on infants or under diapers or occlusivedressings. For external use only. Avoid contact with eyes. May discolor skin, hair or fabrics.www.alcortin.comU.S. Patents 6,436,679; 6,271 ,214;6,133,440; 5,708,038; patent pending2004 Primus Pharmaceuticals, Inc. All rights reserved.Distributed by:Primus Pharmaceuticals, Inc.Scottsdale, AZ 85254www.primusrx.comManufactured by:Harmony Labs, Inc.Landis, NC 28088NDC 68040-702-13Rx only Alcortin 1% iodoquinol 2% hydrocrtisone Anti-fungalAnti-bacterialAnti-inflammatory24 PACKAllergy testedParaben freeContains moisturizersFor dermatological use onlyEach pack containsmultiple doses(depending on the surface area treated)NetWt 48.0g(1.69 oz)24 packs of 2.0g(0.07 oz) each NDC 68040-702-13 Alcortin 1% iodoquinol 2% hydrocrtisone Rx only Anti-fungalAnti-bacterialAnti-inflammatory NDC 68040-702-13 Rx only Alcortin1% iodoquinol 2% hydrocrtisoneAnti-fungalAnti-bacterialAnti-inflammatoryParaben freeContains moisturizersFor dermatological use onlyEach pack containsmultiple dosesNetWt 48.0g(1.69 oz)24 packs of 2.0g(0.07 oz) eachmultiple doses(depending on the surface area treated) U Caton.
SPL PATIENT PACKAGE INSERT SECTION.
Insert. Prescribing Information ALCORTIN gel DESCRIPTION Each gram of Alcortin contains 2.0% (20 mg)Hydrocortisone and 1.0% (10 mg) lodoquinol.Also contains 1.0% (10 mg) Aloe polysaccharideand 5.0% (50 mg) Biopeptide combinationof Palmitoyloligopeptide, Polyglycerylmethacrylateand Propylene glycol. Otheringredients: Aminomethyl propanol, Benzylalcohol, Blue 1, Carbomer, Fragrance, Glycerin,Magnesium aluminum silicate, PPG-20 methylglucose ether, Propylene glycol, Purified water,SO alcohol 40-B and Yellow 10. lodoquinol lodoquinol is an antifungal and antibacterialagent. Chemically, lodoquinol is [5,7-diiodo-8-quinolinol] with the molecular formula(C9HsI2NO) Hydrocortisone Hydrocortisone is an anti-inflammatory andantipruritic agent. Chemically, hydrocortisone is[Pregn-4-ene-3, 20-dione, 11, 17, 21- trihydroxy-,(11 B)-] with the molecular formula(C21H300s) CLINICAL PHARMACOLOGY Hydrocortisone has anti-inflammatory, antipruriticand vasoconstrictive properties. While themechanism of anti-inflammatory activity isunclear, there is evidence to suggest that recognizablecorrelation exists between vasoconstrictorpotency and therapeutic efficacy inhumans. lodoquinol has both antifungal andantibacterial properties. Pharmacokinetics The extent of percutaneous absorption of topicalsteroids is determined by many factorsincluding the vehicle, the integrity of the epidermalbarrier and the use of occlusive dressings.Hydrocortisone can be absorbed from normalintact skin. Inflammation and/or other inflammatorydisease processes in the skin increasepercutaneous absorption. Occlusive dressingssubstantially increase the percutaneousabsorption of topical corticosteroids. Onceabsorbed throuah the skin. hvdrocortisone istetrahydrocortisone and tetrahydrocortisol.These are excreted in the urine, mainly conjugatedas glucuronides, together with verysmall proportion of unchanged hydrocortisone.There are no data available regarding the percutaneousabsorption of iodoquinol; however,following oral administration, 3-5% of the dosewas recovered in the urine as glucuronide. INDICATIONS AND USAGE Based on review of related drug by theNational Research Council and subsequentFDA classification for that drug, the indicationsare as follows: Possibly Effective: Contact oratopiC dermatitis; impetiginized eczema; nummulareczema; endogenous chronic infectiousdermatitis; stasis dermatitis; pyoderma; nuchaleczema and chronic eczematoid otitis externa;acne urticata; localized or disseminated neurodermatitis;lichen simplex chronicus; anogenitalpruritus (vulvae, scroti, ani); folliculitis; bacterialdermatoses; mycotic dermatoses such as tinea(capitis, cruris, corporis, pedis); monliasis; intertrigo.Final classification of the less-than-effectiveindications requires further investigation. CONTRAINDICATIONS Alcortin is contraindicated in those patients witha history of hypersensitivity to hydrocortisone,iodoquinol, aloe vera, glycine, histidine, lysine,palmitic acid or any other components of thepreparation. WARNINGS AND PRECAUTIONS For external use only. Keep away from eyes. Ifirritation develops, the use of Alcortin should bediscontinued and appropriate therapy instituted.Staining of the skin, hair and fabrics may occur.Not intended for use on infants or under diapersor occlusive dressings. If extensive areas aretreated or if the occlusive dressing technique isused, the possibility exists of increased systemicabsorption of the corticosteroid, and suitableprecautions should be taken. Children mayabsorb proportionally larger amounts of topicalcorticosteroids and thus be more susceptible tosystemic toxicity. Parents of pediatric patientsshould be advised not to use tight-fitting diapersor plastic pants on child being treated in thediaper area, as these garments may constituteocclusive dressings. lodoquinol may beabsorbed through the skin and interfere withthyroid function tests. If such tests are contemplated,wait at least one month after discontinuanceof therapy to perform these tests. The ferricchloride test for phenylketonuria (PKU) canyield false positive resJlt if iodoquinol is presentin the diaper or urine. Prolonged use mayresult in overgrowth of non-susceptible organismsrequiring appropriate therapy. Keep out ofreach of children. Burning, itching, irritation anddryness have been reported infrequently followingthe use of topical corticosteroids. Carcinogenesis, Mutagenisis and Impairment ofFertility: Long term animal studies have notbeen performed to evaluate the carcinogenicpotential of the effect on fertility of hydrocortinegativeresults. Mutagenicity studies have notbeen performed with iodoquinol.Pregnancy Category C: Animal reproductivestudies have not been conducted with Alcortin.It is not known whether Alcortin can cause fetalharm when administered to pregnant women orcan affect reproductive capacity. Alcortinshould be given to pregnant women only ifclearly needed. Nursing Mothers: It is not known whether thisdrug is excreted in human milk. Because manydrugs are excreted in human milk, cautionshould be exercised when Alcortin is administeredto nursing woman.Pediatric Use: Safety and effectiveness in pediatricpatients under the age of 12 have not beenestablished. ADVERSE REACTIONS The following local adverse reactions arereported infrequently with topical corticosteroids.These reactions are listed in an approximatedecreasing 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 ADMINISTRATION Apply to affected area 3-4 times daily in accordancewith physicians directions or as directedotherwise by physician. HOW SUPPLIED FORM NDC 68040-702-13 .48.0 gram carton of 24-count of 2.0 gram gel individual packsFORM NDC 68040-702-022.0 gram gel individual packFORM NDC 68040-702-0810 count carton of 2.0 gram gel sample packs not for resaleEach 2.0 gram gel pack contains multiple dosesdepending on the surface area treated. STORAGE Store at room temperature 15-30C (59-86F).Keep tightly closed. Rx only www.alcortin.comU.S. Patents6,436,679; 6,271 ,214; 6,133,440;5,708,038; patent pendingManufactured for:Primus Pharmaceuticals, Inc.Scottsdale, AZ 85254www.primusrx.com.