Label: IODOQUINOL HYDROCORTISONE ACETATE ALOE POLYSACCHARIDES- iodoquinol, hydrocortisone acetate, and aloe vera leaf gel

  • NDC Code(s): 72056-020-48
  • Packager: Syntenza Pharmaceuticals LLC
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated May 6, 2020

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  • SPL UNCLASSIFIED SECTION

    Rx Only

  • DESCRIPTION

    Each gram contains 20 mg of hydrocortisone acetate, 10 mg of iodoquinol and 10 mg of aloe polysaccharide in a vehicle consisting of: aminomethyl propanol, benzyl alcohol, blue 1, carbomer, glycerin, magnesium aluminum silicate, palmitoyl tripeptide-5, PPG-20 methyl glucose ether, purified water, propylene glycol, SD Alcohol 40B, yellow 10.

    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 (C23H32O6) and is represented by the following structural formula:

    Chemical Structure

    Iodoquinol 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:

    Chemical Structure

    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 ß - 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:

    Chemical Structure
  • 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 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

    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.

  • CONTRAINDICATIONS

    This product is contraindicated in persons with known or suspected hypersensitivity to any of the ingredients of the product.

  • WARNINGS

    KEEP OUT OF REACH OF CHILDREN.

  • PRECAUTIONS

    FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. Avoid contact with eyes, lips and mucous membranes.

    Information for Patients

    If irritation develops, the use of this product 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. 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 for carcinogenic potential have not been performed on this product to date. In vitro studies to determine mutagenicity with hydrocortisone have revealed negative results. Mutagenicity studies have not been performed with iodoquinol.

    Pregnancy

    Category C

    Animal reproduction studies have not been conducted with this product. It is also not known whether this product can affect reproduction capacity or cause fetal harm when administered to a pregnant woman. This product should be used by a pregnant woman only if clearly needed or when potential benefits outweigh potential hazards to the fetus.

    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 this product is administered to a nursing woman.

    Pediatric Use

    Safety and effectiveness in pediatric patients 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 infections, skin atrophy, striae and miliaria.

  • DOSAGE AND ADMINISTRATION

    Apply to affected area(s) three to four times per day or as directed by a physician. Follow your physician's directions regarding length of treatment after symptoms resolve.

  • STORAGE

    Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C to 30°C (between 59°F to 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.

    NOTICE: Protect from freezing and excessive heat.

  • HOW SUPPLIED

    This product is supplied in the following size(s):

    48 g Tube, NDC 72056-020-48

    Call your doctor about side effects. You may report side effects to FDA at 1-800-FDA-1088.

  • SPL UNCLASSIFIED SECTION

    Manufactured for:
    Syntenza Pharmaceuticals LLC
    Edina, MN 55436, USA

    SYNTENZA

    Rev 06/18

  • PRINCIPAL DISPLAY PANEL - 48 g Tube Carton

    SYNTENZA

    NDC 72056-020-48

    Iodoquinol 1%-Hydrocortisone Acetate 2%
    Aloe Polysaccharides 1% Gel

    Net Wt. 48 g (1.69 oz.)
    Rx Only

    For external use only.
    Not for ophthalmic use.

    PRINCIPAL DISPLAY PANEL - 48 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    IODOQUINOL HYDROCORTISONE ACETATE ALOE POLYSACCHARIDES 
    iodoquinol, hydrocortisone acetate, and aloe vera leaf gel
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:72056-020
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IODOQUINOL (UNII: 63W7IE88K8) (IODOQUINOL - UNII:63W7IE88K8) IODOQUINOL10 mg  in 1 g
    HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE ACETATE20 mg  in 1 g
    ALOE VERA LEAF (UNII: ZY81Z83H0X) (ALOE VERA LEAF - UNII:ZY81Z83H0X) ALOE VERA LEAF10 mg  in 1 g
    Product Characteristics
    ColorGREENScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72056-020-481 in 1 CARTON11/01/2018
    148 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED DRUG OTHER11/01/2018
    Labeler - Syntenza Pharmaceuticals LLC (080999747)