{"adverse_reactions":["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."],"carcinogenesis_and_mutagenesis_and_impairment_of_fertility":["Carcinogenesis, Mutagenisis and Impairment of Fertility: Long 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."],"clinical_pharmacology":["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. 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 a very small proportion of unchanged hydrocortisone acetate. There is 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."],"contraindications":["CONTRAINDICATIONS Hydro-Iodoquinol 2-1 Gel with Aloe 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."],"description":["DESCRIPTION Each gram of Hydro-Iodoquinol 2-1 Gel with Aloe contains 2.0% (20 mg) Hydrocortisone Acetate and 1.0% (10 mg) Iodoquinol. Also contains 1.0% (10 mg) Aloe polysaccharide. Other Ingredients: Amino Methylpropanol 95%, Benzyl Alcohol, Carbomer, Citric Acid Anhydrous, FD&C Blue #1, FD&C Yellow #10, Glycerin, Glyceryl Polymethacrylate, Magnesium Aluminum Silicate, Palmitoyl Oligopeptide, PPG-20 Methyl Glucose Ether, Propylene Glycol, Purified Water, and SD Alcohol 40B. Iodoquinol Iodoquinol is an antifungal and antibacterial agent. Chemically, Iodoquinol is [5,7-diiodo-8-quinolinol] with the molecular formula (C 9 H 5 I 2 NO) 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-, (11-β)-] with the molecular formula (C 23 H 32 O 6 ) and is represented by the following structural formula: Chemical Structure Chemical Structure"],"dosage_and_administration":["DOSAGE AND ADMINISTRATION Apply to affected area 3-4 times daily in accordance with physician's directions or as directed otherwise by a physician."],"effective_time":"20120802","how_supplied":["HOW SUPPLIED Hydro-Iodoquinol 2-1 Gel with Aloe (NDC 13925-111-24) is a light green gel supplied as follows: 1 carton containing 24 x 2.0 gram individually-wrapped gel packettes (NDC 13925-111-02). Each 2.0 gram gel packette contains multiple doses depending on the surface area treated. STORAGE Store at room temperature 15º-30ºC (59º-86ºF). Keep tightly closed."],"id":"42b1e943-9ad6-4c91-b30a-b2c9964c1e09","indications_and_usage":["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); monliasis; intertrigo. Final classification of the less-than-effective indications requires further investigation."],"nursing_mothers":["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 Hydro-Iodoquinol 2-1 Gel with Aloe is administered to a nursing woman."],"openfda":{},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 24 Pack Carton NDC 13925-111-24 Hydro-Iodoquinol 2-1 Gel with Aloe For External Use Only R x Only 24 Gel Packettes Net wt. 2.0 g each SETON PHARMACEUTICALS Net Wt. 48.0 grams Principal Display Panel - 24 Pack Carton"],"pediatric_use":["Pediatric Use: Safety and effectiveness in pediatric patients under the age of 12 have not been established."],"pharmacokinetics":["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 a very small proportion of unchanged hydrocortisone acetate. There is 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."],"pregnancy":["Pregnancy Category C: Animal reproductive studies have not been conducted with Hydro-Iodoquinol 2-1 Gel with Aloe. It is not known whether Hydro-Iodoquinol 2-1 Gel with Aloe can cause fetal harm when administered to pregnant women or can affect reproductive capacity. Hydro-Iodoquinol 2-1 Gel with Aloe should be given to pregnant women only if clearly needed."],"set_id":"42b1e943-9ad6-4c91-b30a-b2c9964c1e09","spl_product_data_elements":["Hydro-Iodoquinol HYDROCORTISONE ACETATE, ALOE VERA LEAF and Iodoquinol HYDROCORTISONE ACETATE HYDROCORTISONE IODOQUINOL IODOQUINOL AMINOMETHYLPROPANOL BENZYL ALCOHOL CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) ANHYDROUS CITRIC ACID FD&C BLUE NO. 1 D&C YELLOW NO. 10 GLYCERIN MAGNESIUM ALUMINUM SILICATE PALMITOYL OLIGOPEPTIDE PPG-20 METHYL GLUCOSE ETHER PROPYLENE GLYCOL WATER ALCOHOL ALOE VERA LEAF light green"],"spl_unclassified_section":["R x Only","KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. Reserved for Professional Recommendation. Call your doctor about side effects. You may report side effects to FDA at 1-800-FDA-1088. All prescriptions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product. This product may be administered only under a physician’s supervision. There are no implied or explicit claims on therapeutic equivalence. R x Only For External Use Only. Manufactured For: Seton Pharmaceuticals Manasquan, NJ 08736 1-800-510-3401 07/10 SETON PHARMACEUTICALS"],"storage_and_handling":["STORAGE Store at room temperature 15º-30ºC (59º-86ºF). Keep tightly closed."],"teratogenic_effects":["Pregnancy Category C: Animal reproductive studies have not been conducted with Hydro-Iodoquinol 2-1 Gel with Aloe. It is not known whether Hydro-Iodoquinol 2-1 Gel with Aloe can cause fetal harm when administered to pregnant women or can affect reproductive capacity. Hydro-Iodoquinol 2-1 Gel with Aloe should be given to pregnant women only if clearly needed."],"version":"1","warnings":["WARNINGS AND PRECAUTIONS For external use only. Keep away from eyes. If irritation develops, the use of Hydro-Iodoquinol 2-1 Gel with Aloe 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 Fertility: Long 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. Pregnancy Category C: Animal reproductive studies have not been conducted with Hydro-Iodoquinol 2-1 Gel with Aloe. It is not known whether Hydro-Iodoquinol 2-1 Gel with Aloe can cause fetal harm when administered to pregnant women or can affect reproductive capacity. Hydro-Iodoquinol 2-1 Gel with Aloe 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 Hydro-Iodoquinol 2-1 Gel with Aloe is administered to a nursing woman. Pediatric Use: Safety and effectiveness in pediatric patients under the age of 12 have not been established."]}