Label: ATHLETES FOOT- miconazole nitrate cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated March 6, 2025

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

  • Active Ingredient

    Miconazole Nitrate USP, 2%

  • Purpose

    Antifungal

  • Uses

    • cures most athlete’s foot (tinea pedis)
    • cures most jock itch (tinea cruris) and ringworm (tinea corporis)
    • relieves itching, burning, cracking and scaling which accompany theses conditions
  • Warnings

    For external use only

    Do not use

    • on scalp
    • in or near the mouth or eyes
    • for vaginal yeast infections

    When using this productdo not get into eyes. If eye contact occurs, rinse thoroughly with water.
    Stop use and ask a doctor iftoo much irritation occurs or gets worse

    • Keep out of the reach of children.

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

  • KEEP OUT OF REACH OF CHILDREN

  • Directions

    Adults and children 12 years and over:

    • wash affected area with soap and water and dry completely before applying
    • for athlet's footwear well-fitting, ventilated shoes. Change shoes and socks at least once daily.
    • between the tose only:apply twice a day (morning and night) for 1 weekor as directed by doctor
    • on the bottom or sides of the foot: apply twice a day (morning and night) for 2 weeks or as directed by doctor
    • for jock itch and ringworm: apply once a day (morning ornight) for 1 weekor as directed by a doctor
    • wash hands after each use
    • Children under 12 years: ask a doctor
  • Other Information 

    • do not use if seal on the box is broken or is not visible.
    • store at controlled room temperature 20-25°C (68-77°F)
  • Inactive ingredients

    Organic tea tree oil, benzoic acid, cetyl alcohol, isopropyl myristate, polysorbate 60, olive oil, potassium hydroxide, propylene glycol, water, stearyl alcohol

  • Product label

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  • INGREDIENTS AND APPEARANCE
    ATHLETES FOOT 
    miconazole nitrate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83004-014
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE2 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    TEA TREE OIL (UNII: VIF565UC2G)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83004-014-011 in 1 CARTON02/27/2025
    1120 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00502/27/2025
    Labeler - Rida LLC (004425803)