a likely Dermazene Generic Name: hydrocortisone and iodoquinol Dosage Form: cream 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 Dermazene Description Each gram of Dermazene Cream 1% contains 10 mg of hydrocortisone and 10 mg of iodoquinol in a cream base of purified water, propylene glycol, cerasynt SE, amerchol L101, isopropyl palmitate, cetyl alcohol, arlacel 60, myrj 52, tween 60, sorbic acid, methyl paraben and propyl paraben. Chemically, hydrocortisone is [Pregn-4-ene-3,20-dione, 11, 17, 21-trihydroxy-(11β)-] with the molecular formula (C 21 H 30 O 5 ) and is represented by the following structural formula: and iodoquinol, 5,7-diiodo-8-quinolinol (C 9 H 5 I 2 NO) is represented by the following structure: Hydrocortisone is an anti-inflammatory and antipruritic agent, while iodoquinol is an antifungal and antibacterial agent. Slideshow 7 First Aid Kit Must Haves For Your Medicine Cabinet Dermazene - Clinical Pharmacology Hydrocortisone has anti-inflammatory, antipruritic and vasoconstrictor properties. The mechanism of anti-inflammatory activity is unclear. There is some evidence to suggest that a recognizable correlation exists between vasoconstrictor potency and therapeutic efficacy in man. Iodoquinol has both antifungal and antibacterial properties. Pharmacokinetics The extent of percutaneous absorption of topical corticosteroids is determined by many factors including vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings. Hydrocortisone 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 is metabolized in the liver and most body tissues 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. 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 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; infantile 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 declatoses; mycotic dermatoses such as tinea (capitis, cruris, corporis, pedis); moniliasis, intertrigo. Final classification of the less-than-effective indications requires further investigation. Contraindications Dermazene Cream is contraindicated in those patients with a history of hypersensitivity to hydrocortisone, iodoquinol or any other components of the preparation. Warnings and Precautions For external use only. Keep away from eyes. If irritation develops, the use of Dermazene Cream should be discontinued and appropriate therapy instituted. Staining of the skin and fabrics may occur. If extensive areas are treated or if the occlusive 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 the corticosteroids and thus be more susceptible to systemic toxicity. Parents of pediatric patients should be advised not to use tightfitting 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. Carcinogenesis, Mutagenesis, and Impairment of Fertility Long term animal studies have not been performed to evaluate the carcinogenic potential or 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 conducted with iodoquinol. Pregnancy Category C Animal reproductive studies have not been conducted with Dermazene Cream. It is not known whether Dermazene Cream can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Dermazene Cream should be given to a pregnant woman 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 Dermazene Cream is administered to a nursing woman. Pediatric Use Safety and effectiveness in children under the age of 12 have not been established. 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 infection Skin atrophy Striae Miliaria Dermazene Dosage and Administration Apply to affected area 3 to 4 times daily in accordance with physician's directions. How is Dermazene Supplied SIZE NDC NUMBER 1 OZ tube 58980-811-10 Distributed by: STRATUS PHARMACEUTICALS INC Manufactured by: Tarmac Products Inc., Miami Gardens, FL 33014 for Stratus Pharmaceuticals Inc., 12379 SW 130th Street Miami, Florida 33186 Customer Service: 1-800-442-7882 / fax 305-254-6875 1999 Stratus Pharmaceuticals Inc JG-DCI2007-06 (12/99) PRINCIPAL DISPLAY PANEL - 28.4 g Tube Box STRATUS PHARMACEUTICALS INC NDC 58980-811-10 Net WT. 28.4g Dermazene CREAM (HYDROCORTISONE 1% - IODOQUINOL 1%) Rx only Dermazene hydrocortisone and iodoquinol cream Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:58980-811 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength hydrocortisone (hydrocortisone) hydrocortisone 10 mg in 1 g Iodoquinol (Iodoquinol) Iodoquinol 10 mg in 1 g Product Characteristics Color YELLOW (light yellow) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description 1 NDC:58980-811-10 1 TUBE in 1 BOX 1 28.4 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 06/11/2001 Labeler - Stratus Pharamceuticals, Inc (789001641) Establishment Name Address ID/FEI Operations TARMAC PRODUCTS INC 059890491 MANUFACTURE(58980-811), LABEL(58980-811), PACK(58980-811) Revised: 10/2017 Stratus Pharamceuticals, Inc Next Interactions Print this page Add to My Med List More about Dermazene (hydrocortisone / iodoquinol topical) Side Effects Dosage Information Drug Interactions Support Group Pricing & Coupons 0 Reviews Add your own review/rating Drug class: topical steroids with anti-infectives Consumer resources Dermazene Professional resources Hydrocortisone Iodoquinol Cream (FDA) Other brands: Vytone Related treatment guides Dermatitis Eczema FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Drug Status Rx Availability Prescription only C Pregnancy Category Risk cannot be ruled out N/A CSA Schedule Not a controlled drug Drug Class Topical steroids with anti-infectives Related Drugs topical steroids with anti-infectives Lotrisone , Mycolog II , betamethasone / clotrimazole topical , nystatin / triamcinolone topical , Cortisporin Cream Dermatitis fluticasone topical , triamcinolone , hydrocortisone topical , prednisolone , clobetasol topical , betamethasone topical , doxepin topical , mometasone topical , Kenalog , fluocinonide topical , desonide topical , More... 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