Label: KETOCONAZOLE CREAM, 2% cream

  • NDC Code(s): 72641-005-15, 72641-005-30, 72641-005-60
  • Packager: Tasman Pharma Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated November 18, 2021

If you are a consumer or patient please visit this version.

  • DESCRIPTION

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

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


     

    Chemical-structure

    Molecular Formula: C26H28Cl2N4O4 

    Molecular Weight: 531.44


  • 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

    Ketaconozole is a boad spectrum synthetic anti-fungal 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 the ketoconazole in seborrheic dermatitis is due the reduction of M.ovale, but this  has not been  proven.


  • INDICATIONS & 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 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:

    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%) 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 post marketing experience, rare reports of contact dermatitis have been associated with ketoconazole cream or one of its excipients, namely propylene glycol. 

  • DOSAGE & 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 (NDC 72641-005-15), 30 (NDC 72641-005-30), and 60 (NDC 72641-005-60) gram tubes. 

    Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F.) [see USP Controlled Room Temperature].


    Manufactured For: 

    Tasman Pharma Inc. 

    Warminster, PA 18974


    Made in Canada

    Rev. 07/2021   

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC: 72641-005-60

    Ketoconazole Cream 2%
    FOR DERMATOLOGIC USE ONLY

    60g  Rx only

    KEEP OUT OF THE REACH OF CHILDREN

    carton-box

  • INGREDIENTS AND APPEARANCE
    KETOCONAZOLE CREAM, 2% 
    ketoconazole cream, 2% cream
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:72641-005
    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
    BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72641-005-151 in 1 CARTON11/17/2021
    115 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:72641-005-301 in 1 CARTON11/17/2021
    230 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:72641-005-601 in 1 CARTON11/17/2021
    360 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21518511/17/2021
    Labeler - Tasman Pharma Inc. (080860172)