Label: CONAZOL- miconazole nitrate cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated January 15, 2019

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  • Active Ingredients Purpose

    Active ingredients
    Miconazole nitrate 2%     		Purpose
    Antifungal
  • INDICATIONS & USAGE

    Uses

    • effective in the treatment of most athlete's foot, jock
      itch and ringworm
    • relieves itching, cracking, burning and discomfort
      associated with these conditions
  • Warnings

    For external use only

  • Do not use

    on children less than 2 years of age unless
    directed by a doctor

  • When using this product

    • avoid contact with the eyes

  • Stop use and ask a doctor if

    • irritation occurs
    • there is no improvement of athlete's foot or ringworm
      within 4 weeks or jock itch within 2 weeks
  • Keep out of reach of children

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

  • Directions

    • wash 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 the spaces
      between the toes; wear well-fitting, ventilated shoes,
      and change shoes and socks at least once daily
    • for the athlete's foot and ringworm, use daily for 4 weeks
    • for jock itch, use daily for 2 weeks
    • not effective on the scalp or nails
  • Other Information

    Store at 20° to 25°C (68° to 77°F)

  • INACTIVE INGREDIENT

    Drug Facts, cont.

  • Inactive Ingredients

    butylated hidroxyanisole, caprylic/capic triglyceride,
    carbomer 980, emulsifying wax, glycerin, methylparaben,
    propylene glycol, propylparaben, purified water,
    triethanolamine

  • SPL UNCLASSIFIED SECTION

    Questions? Call Toll-Free 1-800-428-9489 ¿Preguntas? Llame gratis al 1-800-428-9489
    Manufactured by / Hecho Por

    Laboratorios Liomont, S.A. de C.V. A, Lopez Mateos 68, Cuajimalpa, 05000 Mexico, D.F. Mexico.
    Distributed by / Distribuido por: MarcasUSA, LLC, El Segundo CA 90245

  • SPL UNCLASSIFIED SECTION

    Datos de Medicamento

  • ACTIVE INGREDIENT

    Ingrediente Activo
    Nitrato de miconazol 2%     		Propósito
    Antimicótico
  • Usos

    • eficaz en el tratamiento de la mayoría del pie de atleta y la tiña inguinal
    • alivia la comezón, grietas, ardor y molestias asociadas con estas condiciones
  • Precauciones

    Sólo para uso externo

  • No lo use

    en niños menores de 2 años de edad a menos
    que lo indique un médico

  • Al utilizar este producto

    • evite el contacto con los ojos
  • Pare su uso consulte al médico, si

    • presenta irritación
    • no hay mejoria del pie de atleta o tiña en un plazo de 4
      semanas o tiña inguinal dentro de 2 semanas
  • Mantener fuera del alcance de los niños.

    En caso de ingestión, obtenga ayuda médica o contacte a
    un Poison Control Center inmediatamente.

  • Modo de Empleo

    • limpie y seque bien el área afectada
    • aplique una capa fina del producto sobre el área
      afectada dos veces al diá (mañana y noche) o según
      las indicaciones de un médico
    • supervise a los niños en el uso de este producto
    • para el pie de atleta, poner especial atención a los espacios
      entre los dedos de los pies, llevar zapatos ventilados y ajustados,
      cambiar los calcetines y zapatos al menos una vez al dia
    • para el pie de atleta, usar diariamente por 4 semanas
    • para tiña inguinal, usar diariamente por 2 semanas
    • no es eficaz en el cuero cabelludo o las uñas
  • Otra información

    • almacene a 20° a 25° C (68° a 77° F)
  • INACTIVE INGREDIENT

    Datos de Medicamento, cont.

  • Ingredientes Inactivos

    hidroxianisol butilado, triglicérido caprilico/cáprico,
    carbomero 980, cera emulsionante, glicerina,
    metilparabeno, propilenglicol, propilparabeno, agua
    purificada, trietanolamina

  • SPL UNCLASSIFIED SECTION

    Questions? Call Toll-Free 1-800-428-9489 ¿Preguntas? Llame gratis al 1-800-428-9489
    Manufactured by / Hecho Por

    Laboratorios Liomont, S.A. de C.V. A, Lopez Mateos 68, Cuajimalpa, 05000 Mexico, D.F. Mexico.
    Distributed by / Distribuido por: MarcasUSA, LLC, El Segundo CA 90245

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - 1.05 oz (30 g)

    ​Works Fast to Get you Back In Action

    NDC 75940-121-30

    Conazol Antifungal

    Cures Most Athlete's Foot

    Cura la Mayoria del Ple de Atleta

    Fast Relief, Absorbs Quickly, Odorless

    NET WT
    1.05 OZ (30g)

    Container Label

  • INGREDIENTS AND APPEARANCE
    CONAZOL 
    miconazole nitrate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75940-121
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE20 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
    TRICAPRIN (UNII: O1PB8EU98M)  
    CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75940-121-3030 g in 1 TUBE; Type 0: Not a Combination Product08/01/2014
    2NDC:75940-121-46130 g in 1 CAN; Type 0: Not a Combination Product08/01/2014
    3NDC:75940-121-022 g in 1 PACKET; Type 0: Not a Combination Product08/01/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C08/01/2014
    Labeler - MarcasUSA LLC (016139820)
    Registrant - MarcasUSA LLC (016139820)
    Establishment
    NameAddressID/FEIBusiness Operations
    Laboratorios Liomont, S.A. de C.V.810347807manufacture(75940-121)
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