Label: ANTIFUNGAL- 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 October 19, 2017

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • ACTIVE INGREDIENT

    Active Ingredient

    Miconazole Nitrate 2%

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  • PURPOSE

    Purpose

    Antifungal

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  • INDICATIONS & USAGE

    Uses

    Treats most jock itch, ringworm and athlete’s foot

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  • WARNINGS

    WarningsDo not use

    • on children under 2 years of age
    • for diaper rash. For external use only.

    Avoid contact with eyes.

    If irritation occurs or if there is no improvement within 4
    weeks for athlete’s foot or ringworm, or within 2 weeks
    for jock itch, discontinue use and consult a doctor.

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  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical
    help or contact a Poison Control Center right away.

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  • DOSAGE & ADMINISTRATION

    Directions

    • Clean the affected area and dry thoroughly.
    • Apply a thin layer of product over affected area twice daily (morning and night), or as directed by a physician.
    • Supervise children in the use of this product.

    Athlete’s foot

    • Pay special attention to the spaces between toes
    • wear well-fitting, ventilated shoes and change shoes and socks at least once daily

    Athlete’s foot and ringworm

    • use daily for 4 weeks

    Jock Itch

    • use daily for 2 weeks. If condition persists longer, consult a doctor.

    This product is not effective on scalp or nails.

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  • STORAGE AND HANDLING

    Other information Store at 59-86ºF (15-30ºC).

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  • INACTIVE INGREDIENT

    Inactive ingredients Purified Water, Isopropyl Palmitate, Glycerin, Glyceryl Stearate, PEG 100 Stearate, Cetearyl Alcohol,
    Cyclopentasiloxane, Propylene Glycol, Polyquaternium-37, Dicaprylate/Dicaprate, PPG-1 Trideceth-6, Aloe Barbadensis Leaf
    Juice, DMDM Hydantoin, Iodopropynyl Butylcarbamate, (may contain Lactic Acid).

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  • SPL UNCLASSIFIED SECTION

    Questions? Call 1-800-777-4908

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  • PRINCIPAL DISPLAY PANEL

    McKesson

    Antifungal Cream

    2% Miconazole Nitrate

    Relieves itching, cracking, scaling and discomfort associated with most jock itch, ringworm and athlete’s foot.

    Net Contents

    4 fl oz

    (118.3mL)

    MFR# 53-6391

    53-6391 each

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  • INGREDIENTS AND APPEARANCE
    ANTIFUNGAL 
    miconazole nitrate cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:68599-1470
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE 2 mg  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    POLYQUATERNIUM-37 (10000 MPA.S) (UNII: 41QWS48DFN)  
    PROPYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: O4446S9CRA)  
    PPG-1 TRIDECETH-6 (UNII: 1K7417JX6Q)  
    ALOE (UNII: V5VD430YW9)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    WATER (UNII: 059QF0KO0R)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    GLYCINE (UNII: TE7660XO1C)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:68599-1470-4 118 mL in 1 TUBE; Type 0: Not a Combination Product 05/26/2017
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333C 05/26/2017
    Labeler - McKesson (023904428)
    Establishment
    Name Address ID/FEI Business Operations
    Central Solutions 007118524 manufacture(68599-1470)
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