Label: PEDIZOLPAK- ketoconazole,miconazole nitrate kit

  • NDC Code(s): 0884-0293-01, 51672-1298-1, 70859-053-01
  • Packager: NuCare Pharmaceuticals,Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL

Drug Label Information

Updated May 4, 2021

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  • SPL UNCLASSIFIED SECTION

    Rx only

  • DESCRIPTION

    Ketoconazole cream, 2% contains the broad-spectrum synthetic antifungal agent, ketoconazole 2%, formulated in an aqueous cream vehicle consisting of butylated hydroxyanisole (BHA), cetyl alcohol, isopropyl myristate, polysorbate 60, polysorbate 80, propylene glycol, purified water, sorbitan monostearate and stearyl alcohol.

    Ketoconazole is cis-1-acetyl-4-[4-[[2-(2,4-dichlorophenyl)-2-(1 H-imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl] piperazine and has the following structural formula:

    Chemical Structure

    Molecular Formula: C 26H 28Cl 2N 4O 4

    Molecular Weight: 531.43

  • CLINICAL PHARMACOLOGY

    When ketoconazole cream, 2% was applied dermally to intact or abraded skin of beagle dogs for 28 consecutive days at a dose of 80 mg, there were no detectable plasma levels using an assay method having a lower detection limit of 2 ng/mL.

    After a single topical application to the chest, back and arms of normal volunteers, systemic absorption of ketoconazole was not detected at the 5 ng/mL level in blood over a 72-hour period.

    Two dermal irritancy studies, a human sensitization test, a phototoxicity study and a photoallergy study conducted in 38 male and 62 female volunteers showed no contact sensitization of the delayed hypersensitivity type, no irritation, no phototoxicity and no photoallergenic potential due to ketoconazole cream, 2%.

    Microbiology

    Ketoconazole is a broad spectrum synthetic antifungal agent which inhibits the in vitro growth of the following common dermatophytes and yeasts by altering the permeability of the cell membrane: dermatophytes: Trichophyton rubrum, T. mentagrophytes, T. tonsurans, Microsporum canis, M. audouini, M. gypseum and Epidermophyton floccosum; yeasts: Candida albicans, Malassezia ovale (Pityrosporum ovale) and C. tropicalis; and the organism responsible for tinea versicolor, Malassezia furfur (Pityrosporum orbiculare). Only those organisms listed in the INDICATIONS AND USAGE section have been proven to be clinically affected. Development of resistance to ketoconazole has not been reported.

    Mode of Action

    In vitro studies suggest that ketoconazole impairs the synthesis of ergosterol, which is a vital component of fungal cell membranes. It is postulated that the therapeutic effect of ketoconazole in seborrheic dermatitis is due to the reduction of M. ovale, but this has not been proven.

  • INDICATIONS AND USAGE

    Ketoconazole cream, 2% is indicated for the topical treatment of tinea corporis, tinea cruris and tinea pedis caused by Trichophyton rubrum, T. mentagrophytes and Epidermophyton floccosum; in the treatment of tinea (pityriasis) versicolor caused by Malassezia furfur (Pityrosporum orbiculare); in the treatment of cutaneous candidiasis caused by Candida spp. and in the treatment of seborrheic dermatitis.

  • CONTRAINDICATIONS

    Ketoconazole cream, 2% is contraindicated in persons who have shown hypersensitivity to the active or excipient ingredients of this formulation.

  • WARNINGS

    Ketoconazole cream, 2% is not for ophthalmic use.

  • PRECAUTIONS

    General

    If a reaction suggesting sensitivity or chemical irritation should occur, use of the medication should be discontinued. Hepatitis (1:10,000 reported incidence) and, at high doses, lowered testosterone and ACTH induced corticosteroid serum levels have been seen with orally administered ketoconazole; these effects have not been seen with topical ketoconazole.

    Carcinogenesis, Mutagenesis, Impairment of Fertility

    A long-term feeding study in Swiss Albino mice and in Wistar rats showed no evidence of oncogenic activity. The dominant lethal mutation test in male and female mice revealed that single oral doses of ketoconazole as high as 80 mg/kg produced no mutation in any stage of germ cell development. The Ames' salmonella microsomal activator assay was also negative.

    Pregnancy

    Teratogenic effects

    Pregnancy Category C

    Ketoconazole has been shown to be teratogenic (syndactylia and oligodactylia) in the rat when given orally in the diet at 80 mg/kg/day, (10 times the maximum recommended human oral dose). However, these effects may be related to maternal toxicity, which was seen at this and higher dose levels.

    There are no adequate and well-controlled studies in pregnant women. Ketoconazole should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

    Nursing Mothers

    It is not known whether Ketoconazole cream, 2% administered topically could result in sufficient systemic absorption to produce detectable quantities in breast milk. Nevertheless, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

    Pediatric Use

    Safety and effectiveness in children have not been established.

  • ADVERSE REACTIONS

    During clinical trials 45 (5.0%) of 905 patients treated with ketoconazole cream, 2% and 5 (2.4%) of 208 patients treated with placebo reported side effects consisting mainly of severe irritation, pruritus and stinging. One of the patients treated with ketoconazole cream developed a painful allergic reaction.

    In worldwide postmarketing experience, rare reports of contact dermatitis have been associated with ketoconazole cream or one of its excipients, namely propylene glycol.

  • DOSAGE AND ADMINISTRATION

    Cutaneous candidiasis, tinea corporis, tinea cruris, tinea pedis, and tinea (pityriasis) versicolor

    It is recommended that ketoconazole cream, 2% be applied once daily to cover the affected and immediate surrounding area. Clinical improvement may be seen fairly soon after treatment is begun; however, candidal infections and tinea cruris and corporis should be treated for two weeks in order to reduce the possibility of recurrence.

    Patients with tinea versicolor usually require two weeks of treatment. Patients with tinea pedis require six weeks of treatment.

    Seborrheic dermatitis

    Ketoconazole cream, 2% should be applied to the affected area twice daily for four weeks or until clinical clearing.

    If a patient shows no clinical improvement after the treatment period, the diagnosis should be redetermined.

  • HOW SUPPLIED

    Ketoconazole cream, 2% is supplied in 15 g (NDC 51672-1298-1).

    Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].

  • SPL UNCLASSIFIED SECTION

    Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1
    Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532

    Revised: March, 2014

    PK-2925-4
    354

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Miconazole Nitrate 2% USP

  • Purpose

    Antifungal

  • USES

    Cures most athlete's foot ( tinea pedis) and ringworm (tinea corporis)

    for effective relief of itchy,scaly skin between the toes.

  • Warnings

    For extenal use only

    WHEN USING THIS PRODUCT

    Avoid contact with the eyes.

    If irritation occurs or if there is no improvement within 4 weeks, discontinue use and consult a doctor.

    Flammable

    Do not use while smoking or near heat or flame

    DO NOT USE

    On children under 2 years of age unless directed by a doctor

    KEEP OUT OF REACH OF CHILDREN

    If swallowed, get medical help or contact a Poison Control Center right away .

  • DIRECTIONS

    clean the affected area and dry thoroughly
    apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor
    supervise children in the use of this product
    for athlete’s foot: pay special attention to spaces between toes; wear well-fitting, ventilated shoes and change shoes and socks at least once daily
    for athlete’s foot and ringworm, use daily for 4 weeks
    if condition persists longer, consult a doctor
    this product is not effective on scalp or nails.

  • OTHER INFORMATION

    store at controlled room temperature 15 o-30 oC (59 o-86 oF)

  • INACTIVE INGREDIENTS

    acetic acid, benzyl alcohol, isopropyl alcohol (30%), laureth-4, water

  • QUESTIONS OR COMMENTS

    1-800-321-4576 or visit www.pedinol.com

  • PedizolPAK

    Contents:

    NDC 0884-0293-01

    1- Pedinol Topical Antifungal 1 fl. oz. (29.57 mL)

    NDC 51672-1298-1

    1- Ketoconazole Cream 2% 15g

    1- Foot File (with extra pads)

    6- Nail Files

  • Ketoconazole 15g NDC 51672-1298-1

    NDC 51672-1298-1

    15 g

    Ketoconazole

    Cream 2%

    FOR DERMATOLOGIC USE ONLY.

    NOT FOR OPHTHALMIC USE.

    Rx only

    Keep this and all medications out of the reach of children.

    TARO

    PRINCIPAL DISPLAY PANEL - 15 g Tube Carton

  • Fungoid Tincture – 1 fl. oz. (29.57 mL) Carton NDC 0884-0293-01

    PDP

  • PedizolPAK NDC 70859-053-01

    pdp

  • INGREDIENTS AND APPEARANCE
    PEDIZOLPAK 
    ketoconazole,miconazole nitrate kit
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70859-053
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70859-053-011 in 1 CARTON09/26/2019
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 TUBE 15 g
    Part 21 BOTTLE, WITH APPLICATOR 29.57 mL
    Part 1 of 2
    KETOCONAZOLE 
    ketoconazole cream
    Product Information
    Item Code (Source)NDC:51672-1298
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    KETOCONAZOLE (UNII: R9400W927I) (KETOCONAZOLE - UNII:R9400W927I) KETOCONAZOLE20 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Product Characteristics
    Colorwhite ((White to off-white)) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51672-1298-11 in 1 CARTON
    115 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07563812/18/2002
    Part 2 of 2
    FUNGOID TINCTURE 
    miconazole nitrate tincture
    Product Information
    Item Code (Source)NDC:0884-0293
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE20 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ACETIC ACID (UNII: Q40Q9N063P)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    WATER (UNII: 059QF0KO0R)  
    LAURETH-4 (UNII: 6HQ855798J)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0884-0293-011 in 1 CARTON
    129.57 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C01/01/1994
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07563812/18/2002
    Labeler - NuCare Pharmaceuticals,Inc. (010632300)
    Establishment
    NameAddressID/FEIBusiness Operations
    NuCare Pharmaceuticals,Inc.010632300manufacture(70859-053)