Label: MICONAZOLE FOOT POWDER- miconazole powder

  • 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 December 13, 2022

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  • Active Ingredients

    Miconazole nitrate 2%

  • Purpose

    Antifungal

  • Uses

    • for the cure of most athlete's foot, jock itch and ringworm
  • Warnings

    For external use only.

    When using this product

    do not get into eyes

    Stop use and ask a doctor if

    • condition worsens
    • symptoms last more than 7 days or clear up and occur again within a few days

    Keep out of reach of children.

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

  • Directions

    • Apply as needed
  • Other information

    • Store at room temperature
  • Inactive ingredients

    Allantoin, Chloroxylenol, Imidurea, Microcrystalline Cellulose, Tricalcium Phosphate,

    Zea Mays Corn Starch

  • Questions?

    Call 1-866-964-0939

  • Pincipal Display Panel

    bulk

    Miconazorb Foot Powder Cornstarch

    2.5 oz

  • INGREDIENTS AND APPEARANCE
    MICONAZOLE FOOT POWDER 
    miconazole powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42669-073
    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
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    IMIDUREA (UNII: M629807ATL)  
    TRICALCIUM PHOSPHATE (UNII: K4C08XP666)  
    ZEA MAYS SUBSP. MAYS WHOLE (UNII: 1G5HNE09V8)  
    ALLANTOIN (UNII: 344S277G0Z)  
    CHLOROXYLENOL (UNII: 0F32U78V2Q)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42669-073-0178 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/19/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C08/19/2022
    Labeler - Davion, Inc. (174542928)
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