Prescribing Information
ALCORTIN A® gel 

DESCRIPTION

Contents: Each gram of ALCORTIN A 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.

Iodoquinol

Iodoquinol is an antifungal and antibacterial agent. Chemically, Iodoquinol is [5,7-diiodo-8-quinolinol] with the molecular formula (C 9H 5I 2NO) and is represented by the following structural formula:

Hydrocortisone Acetate

Hydrocortisone 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 (C 23H 32O 6) and is represented by the following structural formula:

Aloe Polysaccharides

Aloe Polysaccharides are a concentrated, water soluble subcomponent of Aloe vera with a mono-sugar ratio of Man : Gal : Glc: 40 : 1.4 : 1.0, linkage of 1-4 β – linkage, O-Acetyl group of 25% of sugar units, and specific rotation of [α] D= -3.98° at 23.2 °C. Average molecular weight is 80,000 daltons. Chemically, Aloe Polysaccharides is represented by the following structural formula:

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 a recognizable correlation exists between vasoconstrictor potency and therapeutic efficacy in humans. Iodoquinol has both antifungal and antibacterial properties.

INDICATIONS AND USAGE

Based 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); moniliasis; intertrigo. Final classification of the less-than-effective indications requires further investigation.

CONTRAINDICATIONS

ALCORTIN 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 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 Cushing’s syndrome, hyperglycemia, and glucosuria in some patients. 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.

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.

DOSAGE AND ADMINISTRATION

Apply to affected areas 3-4 times daily or as directed by a physician. Follow your physician’s directions regarding length of treatment after symptoms resolve.

HOW SUPPLIED

NDC # 69646-705-15: 48 gram tube 
NDC # 69646-705-13: 48 gram carton of 24-count of 2 gram gel individual packs
NDC # 69646-705-02: 2 gram gel individual pack, not intended for sale separately
NDC # 69646-705-08: 10-count carton of 2 gram gel sample packs - not for resale
NDC # 69646-705-03: 2 gram gel individual tube, not intended for sale separately
NDC # 69646-705-11: 10-count carton of 2 gram gel sample tubes - not for resale 

Each 2 gram gel pack or tube contains multiple doses depending on the surface area treated.

STORAGE

Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (between 59°F and 86°F). Brief exposure to temperatures up to 40°C (104°F) may be tolerated provided the mean kinetic temperature does not exceed 25°C (77°F); however, such exposure should be minimized.

Distributed by:                        
Novum Pharma, LLC                        
Chicago, IL 60606

© 2018 Novum Pharma, LLC. All rights reserved. ALC-022018-057      

PRINCIPAL DISPLAY PANEL

NDC 69646-705-15
Alcortin A
1% iodoquinol- 2% hydrocortisone acetate
1% aloe polysaccharides
Rx Only
Net Wt. 48 g (1.69 oz.)