Label: ALCORTIN - hydrocortisone and iodoquinol gel

  • NDC Code(s): 68040-702-02, 68040-702-08, 68040-702-13
  • Packager: Primus Pharmaceuticals
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

Drug Label Information

Updated 04/10

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  • Alcortin 2.0 g ucarton.jpg

    NDC 68040-702-13 Rx only
    Alcortin
    Anti-fungal
    Anti-bacterial
    Anti-inflammatory
    1% Iodoquinol 2% Hydrocortisone
    See product literature for complete information.
    TO OPEN A SINGLE PACK: Tear at notch along dotted line on front of package.
    DOSAGE: Apply to affected area 3-4 times daily or as directed by your physician.
    CONTENTS: This carton contains 24 single packs of 2.0 grams each of Alcortin gel. Each gram of
    Alcortin contains 2.0% (20 mg) Hydrocortisone and 1.0% (10 mg) lodoquinol. Also contains 1.0%
    (10 mg) Aloe polysaccharide and 5.0% (50 mg) Biopeptide combination of Palmitoyl oligopeptide,
    Polyglyceryl methacrylate and Propylene glycol. Other ingredients: Aminomethyl propanol, Benzyl
    alcohol, Blue 1, Carbomer, Fragrance, Glycerin, Magnesium aluminum silicate, PPG-20 methyl
    glucose ether, Propylene glycol, Purified water, SO alcohol 40-B and Yellow 10.
    WARNING: Keep out of reach of children. Not for use on infants or under diapers or occlusive
    dressings. For external use only. Avoid contact with eyes. May discolor skin, hair or fabrics.
    www.alcortin.com
    U.S. Patents #6,436,679; #6,271 ,214;
    #6,133,440; #5,708,038; patent pending
    2004 Primus Pharmaceuticals, Inc. All rights reserved.
    Distributed by:
    Primus Pharmaceuticals, Inc.
    Scottsdale, AZ 85254
    www.primusrx.com
    Manufactured by:
    Harmony Labs, Inc.
    Landis, NC 28088
    NDC 68040-702-13
    Rx only
    Alcortin
    1% iodoquinol - 2% hydrocrtisone
    Anti-fungal
    Anti-bacterial
    Anti-inflammatory
    24 PACK
    Allergy tested
    Paraben free
    Contains moisturizers
    For dermatological use only
    Each pack contains
    multiple doses
    (depending on the surface area treated)
    NetWt 48.0g(1.69 oz)
    24 packs of 2.0g(0.07 oz) each
    NDC 68040-702-13
    Alcortin
    1% iodoquinol - 2% hydrocrtisone
    Rx only
    Anti-fungal
    Anti-bacterial
    Anti-inflammatory
    NDC 68040-702-13
    Rx only
    Alcortin
    1% iodoquinol - 2% hydrocrtisone
    Anti-fungal
    Anti-bacterial
    Anti-inflammatory
    Paraben free
    Contains moisturizers
    For dermatological use only
    Each pack contains
    multiple doses
    NetWt 48.0g(1.69 oz)
    24 packs of 2.0g(0.07 oz) each
    multiple doses
    (depending on the surface area treated)
    U Caton
    Close
  • Alcortin 2 g packet.jpg

    NDC 68040-702-02 Rx only
    Alcortin gel 1% iodoquinol - 2% hydrocortisone with Aloe
    Allergy tested - Paraben free
    Contains moisturizers
    For dermatological use only
    Each pack contains multiple doses(depending upon the surface area treated)
    NetWt. 2.0 g (0.07oz)
    See product literature for complete information.
    Dosage: Apply to affect area 3-4 times daily or as directed by your physician.
    To Open: Tear at notch along dotted line on front of package.
    Contents: Each gram of Alcortin contains 2.0% (20 mg Hydrocortisone and 1.0% (10 mg) Iodoquinol.
    Also contains 1.0% (10 mg) Aloe polysaccharide and 5.0% (50 mg) Biopeptide combination of Palmitoyl oligopeptide, Poyglyceryl methacrylate and Propylene glycol. Other ingredients: Aminomethyl propanol, Benzyl alcohol, Blue 1, Carbomer, Fragrance, Glycerin, Magnesium aluminum silicate, PPG-20 methyl glucose ether, Propylene glycol, Purified water, SD alcohol 40-B and Yellow 10.
    Warning: Keep out of reach of children. Not for use on infants or under diapers or occlusive dressings. For external use only. Avoid contact with eyes. May discolor skin, hair or fabrics.
    www.alcortin.com
    Distributed by: Primus Pharmaceuticals, Inc.
    Scottsdale, AZ 85254
    Manufactured by: Harmony Labs, Inc.
    Landis, NC 28088
    U.S. Patents #6,436,679; #6,271,214; #6,133,440; #5,708,038; patent pending
    Packet
    Close
  • Insert

    Prescribing Information
    ALCORTINgel
    DESCRIPTION
    Each gram of Alcortin contains 2.0% (20 mg)
    Hydrocortisone and 1.0% (10 mg) lodoquinol.
    Also contains 1.0% (10 mg) Aloe polysaccharide
    and 5.0% (50 mg) Biopeptide combination
    of Palmitoyloligopeptide, Polyglycerylmethacrylate
    and Propylene glycol. Other
    ingredients: Aminomethyl propanol, Benzyl
    alcohol, Blue 1, Carbomer, Fragrance, Glycerin,
    Magnesium aluminum silicate, PPG-20 methyl
    glucose ether, Propylene glycol, Purified water,
    SO alcohol 40-B and Yellow 10.
    lodoquinol
    lodoquinol is an antifungal and antibacterial
    agent. Chemically, lodoquinol is [5,7-diiodo-8-
    quinolinol] with the molecular formula
    (C9HsI2NO)
    Hydrocortisone
    Hydrocortisone is an anti-inflammatory and
    antipruritic agent. Chemically, hydrocortisone is
    [Pregn-4-ene-3, 20-dione, 11, 17, 21- trihydroxy-,
    (11 B)-] with the molecular formula
    (C21H300s)
    CLINICAL PHARMACOLOGY
    Hydrocortisone 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. lodoquinol 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 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 throuah the skin. hvdrocortisone is
    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; 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
    Alcortin is contraindicated in those patients with
    a history of hypersensitivity to hydrocortisone,
    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. 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 a child being treated in the
    diaper area, as these garments may constitute
    occlusive dressings. lodoquinol 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 res!Jlt 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 hydrocortinegative
    results. Mutagenicity studies have not
    been performed with iodoquinol.
    Pregnancy Category C: Animal reproductive
    studies have not been conducted with Alcortin.
    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 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 3-4 times daily in accordance
    with physician's directions or as directed
    otherwise by a physician.
    HOW SUPPLIED
    FORM NDC # 68040-702-13 .
    48.0 gram carton of 24-count of 2.0 gram gel individual packs
    FORM NDC # 68040-702-02
    2.0 gram gel individual pack
    FORM NDC # 68040-702-08
    10 count carton of 2.0 gram gel sample packs - not for resale
    Each 2.0 gram gel pack contains multiple doses
    depending on the surface area treated.
    STORAGE
    Store at room temperature 15°-30°C (59°-86°F).
    Keep tightly closed.
    Rx only www.alcortin.com
    U.S. Patents
    #6,436,679; #6,271 ,214; #6,133,440;
    #5,708,038; patent pending
    Manufactured for:
    Primus Pharmaceuticals, Inc.
    Scottsdale, AZ 85254
    www.primusrx.com

    Close
  • INGREDIENTS AND APPEARANCE
    ALCORTIN 
    1% iodoquinol - 2% hydrocortisone gel
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:68040-702
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Hydrocortisone (Hydrocortisone) Hydrocortisone 2 g  in 100 g
    IODOQUINOL (IODOQUINOL) IODOQUINOL 1 g  in 100 g
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:68040-702-08 64 in 1 BOX
    1 10 in 1 CARTON
    1 NDC:68040-702-02 2 g in 1 PACKET
    2 NDC:68040-702-13 12 in 1 BOX
    2 24 in 1 CARTON
    2 2 g in 1 PACKET
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 07/25/2003
    Labeler - Primus Pharmaceuticals (130834745)
    Registrant - Harmony Labs, Inc. (105803274)
    Establishment
    Name Address ID/FEI Business Operations
    Harmony Labs, Inc. 105803274 manufacture, label, pack, repack, relabel
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