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 September 1, 2017

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

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  • DO NOT USE

    Do not use on children under 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 within 4 weeks (for athlete's foot and ringworm) or within 2 weeks (for jock itch)
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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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  •  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.

    Distributed by: Actavis

    Relabeled by:

    Proficient Rx LP

    Thousand Oaks, CA 91320

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  • Principal Display Panel


    NDC 63187-885-15
    Compare to the active ingredient in Micatin® Antifungal Cream 

    Antifungal Cream
    Miconazole Nitrate Cream, USP 2%
    Soothes Itching, Scaling, Cracking, and Burning 

    Cures Most Athlete’s Foot, Jock Itch & Ringworm 

    Net wt. 0.5 oz (14g)

    63187-885-15
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  • INGREDIENTS AND APPEARANCE
    ANTIFUNGAL 
    miconazole nitrate cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:63187-885(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:63187-885-15 1 in 1 CARTON 09/01/2017
    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 05/01/2007
    Labeler - Proficient Rx LP (079196022)
    Establishment
    Name Address ID/FEI Business Operations
    Proficient Rx LP 079502574 RELABEL(63187-885)
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