Label: MICONAZOLE NITRATE ANTIFUNGAL POWDER powder

  • NDC Code(s): 10135-720-85
  • Packager: Marlex Pharmaceuticals, Inc.
  • 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 May 5, 2022

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

  • Active ingredient

    Miconazole Nitrate 2%

  • Purpose

    Antifungal

  • Uses

    • For the treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis)
    • For the treatment of most superficial skin infections caused by yeast (candida albicans)
    • Relieves most itching, scaling, cracking, burning, redness, soreness, irritation, discomfort and chafing associated with jock itch
  • Warnings

    • For external use only
  • Do not use

    • on children under 2 years of age unless directed by a doctor
    • avoid contact with the eyes
    • for athlete's foot and ringworm- if irritation occurs, or if there is no improvement within 4 weeks, discontinue use and consult a doctor
    • for jock itch - if irritation occurs or if there is no improvement within 2 weeks, discontinue use and consult a doctor
  • Keep out of reach of children

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

  • Directions

    • Clean the affected area and dry thoroughly
    • Apply a layer of power over affected area twice a day (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 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 persists longer, consult a doctor
    • This product is not effective on the scalp or nails.
  • Other Information

    • Protect from freezing. Avoid excessive heat.
    • Do not use if package is damaged
  • Inactive ingredients

    Allantoin, Chloroxylenol, fragrance, Imidazolidinyl Urea, Microcrystalline Cellulose, Tricalcium Phosphate, Corn starch.

    Manufactured For/ Distributed By:

    Marlex Pharmaceuticals, Inc.

    New Castle, DE 19720

    Rev. 04/22 DV

  • Principal Display Panel

    label

  • INGREDIENTS AND APPEARANCE
    MICONAZOLE NITRATE ANTIFUNGAL POWDER 
    miconazole nitrate antifungal powder powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10135-720
    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
    CHLOROXYLENOL (UNII: 0F32U78V2Q)  
    IMIDUREA (UNII: M629807ATL)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    TRICALCIUM PHOSPHATE (UNII: K4C08XP666)  
    ALLANTOIN (UNII: 344S277G0Z)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10135-720-8585 g in 1 BOTTLE; Type 0: Not a Combination Product05/01/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C05/01/2022
    Labeler - Marlex Pharmaceuticals, Inc. (782540215)
    Establishment
    NameAddressID/FEIBusiness Operations
    Davion, Inc.079536689manufacture(10135-720)