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 January 18, 2018

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

  • Drug Facts
  • Active ingredient

    Miconazole nitrate, USP 2%

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  • Purpose

    Antifungal

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  • Uses

    • proven clinically effective in the treatment of most athlete's foot, jock itch, and ringworm
    • for effective relief of itching, scaling, cracking, burning, and discomfort
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  • 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 the eyes

    Stop use and ask a doctor if

    • irritation occurs
    • there is no improvement within 4 weeks (for athlete's foot and ringworm) or 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.

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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 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; for jock itch, use daily for 2 weeks
    • if condition lasts longer, contact a doctor
    • this product is not effective on the scalp or nails
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  • Other information

    • store at controlled room temperature 59°-86°F (15°-30°C).
    • before using any medication, read all label directions. Keep carton, it contains important information.
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  • Inactive ingredients

    benzoic acid, butylated hydroxyanisole, mineral oil, oleoyl polyoxylglycerides, pegoxol 7 stearate, purified water

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  • Questions?

     1-800-432-8534 between 9 am and 4 pm EST, Monday-Friday.

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  • HOW SUPPLIED

    Product: 50090-2231

    NDC: 50090-2231-0 14 g in a TUBE

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  • miconazole nitrate
  • INGREDIENTS AND APPEARANCE
    ANTIFUNGAL 
    miconazole nitrate cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:50090-2231(NDC:0472-0735)
    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
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PEGOXOL 7 STEARATE (UNII: 3EW5AXE5X5)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:50090-2231-0 1 in 1 CARTON 11/16/2015
    1 14 g in 1 TUBE ; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part333C 06/01/1997
    Labeler - A-S Medication Solutions (830016429)
    Establishment
    Name Address ID/FEI Business Operations
    A-S Medication Solutions 830016429 RELABEL(50090-2231)
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