Label: ANTIFUNGAL CREAM- miconazole nitrate cream

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

Drug Label Information

Updated September 4, 2025

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

  • ACTIVE INGREDIENT(S)

    Miconazole nitrate, USP 2%

  • PURPOSE

    Antifungal

  • USE(S)

    ■ 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

  • 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 DOCTOR IF

    ■ irritation occurs

    ■ there is no improvement within 4 weeks (for athlete's foot and ringworm) or within 2 weeks (for jock itch)

  • KEEP OUT OF REACH OF CHILDREN

    If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) 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: pay special attention to the spaces between the toes; wear well-filling, 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

  • OTHER INFORMATION

    ■ do not use if foil seal on tube opening is broken or missing

    ■ to open tube: unscrew cap, lift tab, and pull to remove foil seal prior to use

    ■ store at room temperature 15°C to 30°C (59°F to 86°F)

    ■ before using any medication, read all label directions. Keep carton, it contains important information.

  • INACTIVE INGREDIENTS

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

  • QUESTIONS OR COMMENTS?

    Call 1-833-285-4151

  • PRINCIPAL DISPLAY PANEL

    Antifungal Cream
    Miconazole Nitrate Cream, USP 2%

    NET WT. 1.5 OZ (42.5 g)


    carton

  • INGREDIENTS AND APPEARANCE
    ANTIFUNGAL CREAM 
    miconazole nitrate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21922-095
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    APRICOT KERNEL OIL PEG-6 ESTERS (UNII: DRG3KJZ1TJ)  
    PEGOXOL 7 STEARATE (UNII: 3EW5AXE5X5)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:21922-095-061 in 1 CARTON03/06/2025
    142.5 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00503/06/2025
    Labeler - Encube Ethicals, Inc. (116982244)
    Registrant - Encube Ethicals Private Limited (915834105)
    Establishment
    NameAddressID/FEIBusiness Operations
    Encube Ethicals Private Limited725076298analysis(21922-095) , label(21922-095) , manufacture(21922-095) , pack(21922-095)