Label: ANTIFUNGAL- miconazole nitrate cream

  • Category: HUMAN OTC DRUG LABEL

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 April 1, 2021

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  • Drug Facts

  • Active ingredient

    Miconazole nitrate, USP 2%

  • Purpose

    Antifungal

  • 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
  • Warnings

    For external use only

  • DO NOT USE

    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

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

  •  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
  • 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.
  • Inactive ingredients

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

  • 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

  • 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
  • INGREDIENTS AND APPEARANCE
    ANTIFUNGAL 
    miconazole nitrate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63187-885(NDC:0472-0735)
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE20 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PEGOXOL 7 STEARATE (UNII: 3EW5AXE5X5)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63187-885-151 in 1 CARTON09/01/2017
    114 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C05/01/2007
    Labeler - Proficient Rx LP (079196022)
    Establishment
    NameAddressID/FEIBusiness Operations
    Proficient Rx LP079196022RELABEL(63187-885)
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