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 July 24, 2017

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • Drug Facts
  • Active ingredient

    Miconazole nitrate, USP 2%

    Close
  • Purpose

    Antifungal

    Close
  • 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
    Close
  • Warnings

    For external use only

    Close
  • DO NOT USE

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

    Close
  • When using this product

    • avoid contact with the eyes
    Close
  • 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)
    Close
  • 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.

    Close
  •  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
    Close
  • 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.
    Close
  • Inactive ingredients

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

    Close
  • Questions?

      1-800-432-8534 between 9 am and 4 pm EST, Monday- Friday.

    Close
  • Principal Display Panel
  • INGREDIENTS AND APPEARANCE
    ANTIFUNGAL 
    miconazole nitrate cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:66267-960(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:66267-960-30 30 g in 1 TUBE; Type 0: Not a Combination Product 07/24/2017
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333C 05/01/2007
    Labeler - NuCare Pharmaceuticals, Inc. (010632300)
    Establishment
    Name Address ID/FEI Business Operations
    NuCare Pharmaceuticals, Inc. 010632300 relabel(66267-960)
    Close