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 October 2, 2012

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

  • Active ingredient

    Miconazole nitrate 2%

  • Purpose

    Antifungal

  • Uses

    • proven clinically effective in the treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris) and ringworm (tinea corporis)
    • relieves itching, scaling, cracking, burning and discomfort associated with those conditions
  • 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 or if there is no improvement within 4 weeks (for athlete's foot and ringworm)
    • irritation occurs or if there is no improvement 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.

  • 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

    For athlete's foot:

    • use daily for 4 weeks. If condition persists longer, consult a doctor.
    • pay special attention to the spaces between the toes
    • wear well-fitting, ventilated shoes
    • change shoes and socks at least once daily

    For ringworm, use daily for 4 weeks. If condition persists longer, consult a doctor.

    For jock itch, use daily for 2 weeks. If condition persists longer, consult a doctor.

    This product is not effective on the scalp or nails.

  • Other information

    • store at 15° - 30°C (59° - 86°F)
    • lot number and expiration date: see crimp of tube or see box
    • to open: unscrew cap, use pointed end on cap to puncture seal

    You may report serious side effects to: 130 Vintage Drive, Huntsville, AL 35811.

  • Inactive ingredients

    benzoic acid, butylated hydroxyanisole, mineral oil, peglicol 5 oleate, pegoxol 7 stearate, purified water

  • SPL UNCLASSIFIED SECTION

    Made in the USA
    for Qualitest Pharmaceuticals
    Huntsville, AL 35811

    Rev. 10/09 R2
    8280719 7805

    Repackaged by
    Rebel Distributors Corp.
    Thousand Oaks, CA 91320

  • PRINCIPAL DISPLAY PANEL

    Miconazole Nitrate 2%
  • INGREDIENTS AND APPEARANCE
    MICONAZOLE NITRATE 
    miconazole nitrate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42254-319(NDC:0603-7805)
    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)  
    PEG-5 OLEATE (UNII: 0240V77G50)  
    PEGOXOL 7 STEARATE (UNII: 3EW5AXE5X5)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42254-319-301 in 1 CARTON
    128.4 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C09/01/2003
    Labeler - Rebel Distributors Corp (118802834)
    Registrant - PSS World Medical, Inc. (101822862)
    Establishment
    NameAddressID/FEIBusiness Operations
    PSS World Medical, Inc.791528623REPACK(42254-319)
    Establishment
    NameAddressID/FEIBusiness Operations
    STAT RX USA LLC786036330REPACK(42254-319)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dispensing Solutions, Inc.066070785RELABEL(42254-319) , REPACK(42254-319)
    Establishment
    NameAddressID/FEIBusiness Operations
    SCRIPT PAK964420108RELABEL(42254-319) , REPACK(42254-319)
    Establishment
    NameAddressID/FEIBusiness Operations
    Keltman Pharmaceuticals, Inc.362861077REPACK(42254-319)
    Establishment
    NameAddressID/FEIBusiness Operations
    Rebel Distirbutors Corp.118802834RELABEL(42254-319) , REPACK(42254-319)