Label: MICONAZOLE NITRATE- miconazole nitrate cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 10/12

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

  • Active ingredient

    Miconazole nitrate 2%

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  • Purpose

    Antifungal

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  • 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
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  • Warnings
  • For external use only
  • 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 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)
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  • Keep out of reach of children.

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

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  • 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.

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  • 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.

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  • Inactive ingredients

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

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  • 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

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  • PRINCIPAL DISPLAY PANEL
  • INGREDIENTS AND APPEARANCE
    MICONAZOLE NITRATE 
    miconazole nitrate cream
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:42254-319(NDC:0603-7805)
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MICONAZOLE NITRATE (MICONAZOLE) MICONAZOLE NITRATE 20 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    BENZOIC ACID  
    BUTYLATED HYDROXYANISOLE  
    MINERAL OIL  
    PEG-5 OLEATE  
    PEGOXOL 7 STEARATE  
    WATER  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:42254-319-30 1 in 1 CARTON
    1 28.4 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333C 09/01/2003
    Labeler - Rebel Distributors Corp (118802834)
    Registrant - PSS World Medical, Inc. (101822862)
    Establishment
    Name Address ID/FEI Business Operations
    PSS World Medical, Inc. 791528623 REPACK(42254-319)
    Establishment
    Name Address ID/FEI Business Operations
    STAT RX USA LLC 786036330 REPACK(42254-319)
    Establishment
    Name Address ID/FEI Business Operations
    Dispensing Solutions, Inc. 066070785 RELABEL(42254-319), REPACK(42254-319)
    Establishment
    Name Address ID/FEI Business Operations
    SCRIPT PAK 964420108 RELABEL(42254-319), REPACK(42254-319)
    Establishment
    Name Address ID/FEI Business Operations
    Keltman Pharmaceuticals, Inc. 362861077 REPACK(42254-319)
    Establishment
    Name Address ID/FEI Business Operations
    Rebel Distirbutors Corp. 118802834 RELABEL(42254-319), REPACK(42254-319)
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