Label: CONAZOL- miconazole nitrate cream

  • NDC Code(s): 59208-001-30
  • Packager: Laboratorios Liomont, S.A. de C.V.
  • 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 May 16, 2019

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  • Active Ingredient

    Miconazole nitrate 2%

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  • Purpose

    Antifungal

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  • Uses

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

    For external use only

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  • Do not use

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

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  • When using this product

    • avoid contact with the eyes

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  • 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
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  • Keep out of reach of children

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

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  • 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
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  • Other Information

    • store at 20° to 25°C (68° to 77°F)
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  • Inactive Ingredients

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

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  • Package Label

    Package Label

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  • INGREDIENTS AND APPEARANCE
    CONAZOL 
    miconazole nitrate cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:59208-001
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE 20 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:59208-001-30 30 g in 1 TUBE; Type 0: Not a Combination Product 03/01/2019
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333C 03/01/2019
    Labeler - Laboratorios Liomont, S.A. de C.V. (810347807)
    Establishment
    Name Address ID/FEI Business Operations
    Laboratorios Liomont, S.A. de C.V. 810347807 manufacture(59208-001)
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