Label: MICONI-AL- miconazole nitrate liquid

  • NDC Code(s): 83592-580-30
  • Packager: True Marker Pharmaceuticals, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 26, 2023

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  • Active Ingredient (s)

    Miconazole Nitrate 2%

  • Purpose

    Topical Antifungal

  • Uses

    • Proven clinically effective in the treatment of most fungal infections including related/associated to tinea pedis (athlete’s foot), tinea cruris (jock itch) and tinea corporis (ringworm)
    • For effective relief of itching, scaling, cracking, burning, redness, soreness, irritation, discomfort associated to fungal infections
    • Prevents most tinea pedis (athlete’s foot) with daily use.

  • Warnings

    • For external use only
    • Do Not Use– On children under 2 years of age unless directed by a doctor.
    • When using this product, avoid contact with eyes.
    • Stop use and ask a doctor, if irritation occurs of if there is no improvement within 4 weeks, discontinue use and consult a doctor (within 2 weeks for jock itch)
    • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
    • If pregnant or breast-feeding, ask a health professional before use.
  • KEEP OUT OF REACH OF CHILDREN

  • 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
    • Pay special attention to spaces between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily
    • Supervise children in the use of this product
    • For athlete’s foot: pay special attention to spaces between the 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 the scalp or nails.
  • Other information

    Protect the product in this container from excessive heat and direact sun

  • Inactive Ingredients

    Helianthus annuus flowering top, Vitis Vinifera Fruit Oil, Peppermint, Alpha-Tocopherol Acetate, Butylated Hydroxytoluene.

  • QUESTIONS? 602-887-9879

  • Product label

    image description

  • INGREDIENTS AND APPEARANCE
    MICONI-AL 
    miconazole nitrate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83592-580
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE2 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)  
    VITIS VINIFERA FRUIT OIL (UNII: YQ5Q4Y2Z8U)  
    PEPPERMINT (UNII: V95R5KMY2B)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83592-580-301 in 1 CARTON10/17/2023
    130 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00510/17/2023
    Labeler - True Marker Pharmaceuticals, Inc. (119046582)