Label: 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 November 5, 2012

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

  • ACTIVE INGREDIENT

    Miconazole nitrate 2%

  • PURPOSE

    Antifungal

  • USES

    • treats most athlete’s foot, jock itch and ringworm
    • relieves itching, scaling, burning, irritation and discomfort
  • WARNINGS

    For external use only

  • WHEN USING THIS PRODUCT

    • do not get into the eyes
  • STOP USE AND ASK A DOCTOR IF

    • irritation occurs
    • there is no improvement within 4 weeks (for athlete’s foot or ringworm) or within 2 weeks (for jock itch)

    Do not use on children under 2 years, unless directed by a doctor.

  • KEEP OUT OF REACH OF CHILDREN

    If swallowed, get medical help or contact a Poison Control Center right away.

  • 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
    • supervise children in the use of this product
    • this product does not work on the scalp or nails

    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 every day

      For athlete’s foot and ringworm

    • use every day for 4 weeks

      For jock itch

    • use every day for 2 weeks. If condition lasts longer, contact a doctor.
  • OTHER INFORMATION

    Store at room temperature 59º - 86ºF (15º - 30ºC).

    IMPORTANT: The opening of this product is covered by a metal tamper-evident seal. If this seal has been punctured or is not visible, do not use and return product to place of purchase.

    TO OPEN: To puncture the seal, reverse the cap and place the puncture-top onto the tube. Push firmly until seal is open. To close, screw the cap back onto the tube.

  • INACTIVE INGREDIENTS

    Benzoic acid, BHA, mineral oil, peglicol 5 oleate, pegoxol 7 stearate, purified water

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 54868-2471-0

    image of package label

    Compare to the active ingredient in Micatin® Antifungal Cream*

    Actavis

    Antifungal Cream

    Miconazole Nitrate 2%

    Relieves Burning, Cures Most Athlete’s Foot, Jock Itch, Ringworm

    Net wt. 14 g  tube cream

    07350200D1 VC106266






    Additional barcode labeling by:
    Physicians Total Care, Inc.
    Tulsa, Oklahoma      74146
  • INGREDIENTS AND APPEARANCE
    MICONAZOLE NITRATE 
    miconazole nitrate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54868-2471(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)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54868-2471-01 in 1 CARTON
    114 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart333C03/20/2012
    Labeler - Physicians Total Care, Inc. (194123980)
    Establishment
    NameAddressID/FEIBusiness Operations
    Physicians Total Care, Inc.194123980relabel(54868-2471)