CONTRAINDICATIONS SECTION.


CONTRAINDICATIONS. ALCORTIN is contraindicated in those patients with history of hypersensitivity to Hydrocortisone Acetate, Iodoquinol, aloe vera, glycine, histidine, lysine, palmitic acid, or any other components of the preparation.

ADVERSE REACTIONS SECTION.


ADVERSE REACTIONS. The 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. Possible local adverse reactions associated with topical iodoquinol include burning, itching, irritation, and dryness.

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY SECTION.


Carcinogenesis, Mutagenesis and Impairment of Fertility: Long-term animal studies have not been performed to evaluate the carcinogenic potential of the effect on fertility of Hydrocortisone Acetate or Iodoquinol. In vitro studies to determine mutagenicity with Hydrocortisone Acetate have revealed negative results. Mutagenicity studies have not been performed with Iodoquinol.

CLINICAL PHARMACOLOGY SECTION.


CLINICAL PHARMACOLOGY. Hydrocortisone Acetate has anti-inflammatory, antipruritic and vasoconstrictive properties. While the mechanism of anti-inflammatory activity is unclear, there is evidence to suggest that recognizable correlation exists between vasoconstrictor potency and therapeutic efficacy in humans. Iodoquinol has both antifungal and antibacterial properties.. Pharmacokinetics. The 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 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 glucuronide.

DESCRIPTION SECTION.


DESCRIPTION. Contents: Each gram of ALCORTIN contains 2.0% (20 mg) Hydrocortisone Acetate, 1.0% (10 mg) Iodoquinol, and 1.0% (10 mg) Aloe Polysaccharides. 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 D&C Yellow 10.IodoquinolIodoquinol is an antifungal and antibacterial agent. Chemically, Iodoquinol is [5,7-diiodo-8-quinolinol] with the molecular formula (C9H5I2NO) and is represented by the following structural formula:Hydrocortisone AcetateHydrocortisone Acetate is an anti-inflammatory and antipruritic agent. Chemically, Hydrocortisone Acetate is [Pregn-4-ene-3, 20-dione, 21-(acetyloxy)-11, 17-dihydroxy-, (11ss)-] with the molecular formula (C23H32O6) and is represented by the following structural formula: Aloe PolysaccharidesAloe Polysaccharides are concentrated, water soluble subcomponent of Aloe vera with mono-sugar ratio of Man Gal Glc: 40 1.4 1.0, linkage of 1-4 linkage, O-Acetyl group of 25% of sugar units, and specific rotation of []D= -3.98 at 23.2 C. Average molecular weight is 80,000 daltons. Chemically, Aloe Polysaccharides is represented by the following structural formula:. Iodoquinol structral formula Hydrocortisone Acetate structural formula Aloe Polysaccharides structural formula.

DOSAGE & ADMINISTRATION SECTION.


DOSAGE AND ADMINISTRATION. Apply to affected areas 3-4 times daily or as directed by physician. Follow your physicians directions regarding length of treatment after symptoms resolve.

HOW SUPPLIED SECTION.


HOW SUPPLIED. NDC 69646-705-15: 48 gram tube NDC 69646-705-13: 48 gram carton of 24-count of gram gel individual packs NDC 69646-705-02: gram gel individual pack, not intended for sale separatelyNDC 69646-705-08: 10-count carton of gram gel sample packs not for resaleNDC 69646-705-03: gram gel individual tube, not intended for sale separatelyNDC 69646-705-11: 10-count carton of gram gel sample tubes not for resale Each gram gel pack or tube contains multiple doses depending on the surface area treated.

INDICATIONS & USAGE SECTION.


INDICATIONS AND USAGE. Based on review of 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); moniliasis; intertrigo. Final classification of the less-than-effective indications requires further investigation.

NURSING MOTHERS SECTION.


Nursing Mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when ALCORTIN is administered to nursing woman.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.


PRINCIPAL DISPLAY PANEL. NDC 69646-705-15Alcortin A1% iodoquinol- 2% hydrocortisone acetate1% aloe polysaccharidesRx OnlyNet Wt. 48 (1.69 oz.) NDC 69646-705-15Alcortin A1% iodoquinol- 2% hydrocortisone acetate1% aloe polysaccharidesRx OnlyNet Wt. 48 (1.69 oz.).

PEDIATRIC USE SECTION.


Pediatric Use: Safety and effectiveness in pediatric patients under the age of 12 have not been established.

PHARMACOKINETICS SECTION.


Pharmacokinetics. The 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 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 glucuronide.

PREGNULLNCY SECTION.


Pregnancy Category C: Animal reproductive studies have not been conducted with ALCORTIN A. It is not known whether ALCORTIN can cause fetal harm when administered to pregnant women or can affect reproductive capacity. ALCORTIN should be given to pregnant women only if clearly needed.

SPL UNCLASSIFIED SECTION.


Prescribing InformationALCORTIN A(R) gel.

STORAGE AND HANDLING SECTION.


STORAGE. Store at 20C to 25C (68F to 77F), excursions permitted between 15C and 30C (between 59F and 86F). Brief exposure to temperatures up to 40C (104F) may be tolerated provided the mean kinetic temperature does not exceed 25C (77F); however, such exposure should be minimized.Distributed by: Novum Pharma, LLC Chicago, IL 60606(C) 2018 Novum Pharma, LLC. All rights reserved. ALC-022018-057.

WARNINGS AND PRECAUTIONS SECTION.


WARNINGS AND PRECAUTIONS. For external use only. Keep away from eyes. Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushings syndrome, hyperglycemia, and glucosuria in some patients. If irritation develops, the use of ALCORTIN 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 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 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, Mutagenesis and Impairment of Fertility: Long-term animal studies have not been performed to evaluate the carcinogenic potential of the effect on fertility of Hydrocortisone Acetate or Iodoquinol. In vitro studies to determine mutagenicity with Hydrocortisone Acetate have revealed negative results. Mutagenicity studies have not been performed with Iodoquinol. Pregnancy Category C: Animal reproductive studies have not been conducted with ALCORTIN A. It is not known whether ALCORTIN can cause fetal harm when administered to pregnant women or can affect reproductive capacity. ALCORTIN should be given to pregnant women only if clearly needed. Nursing Mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when ALCORTIN is administered to nursing woman. Pediatric Use: Safety and effectiveness in pediatric patients under the age of 12 have not been established.