Label: MICONAZOLE NITRATE- antifungal miconazorb af powder talc free powder

  • NDC Code(s): 55319-144-71
  • Packager: Family Dollar Services 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 July 20, 2021

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

  • 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.

    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 a doctor if

    irritation occurs or there is no improvement within 4 weeks for athlete's foot and ringworm, or 2 weeks for jock itch.

    Keep out of reach of children.

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

  • Directions

    • clean the affected area & 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, & change shoes & socks at least once daily
    • for athlete's foot & 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

    • store between 59º - 86ºF
    • lightly shake bottle to loosen settled powder
  • Inactive ingredients

    allantoin, chloroxylenol, fragrance, imidazolidinyl urea, microcrystalline cellulose, tricalcium phosphate, zea mays (corn) starch

  • Questions?

    Call 1-866-964-0939

  • Pincipal Display Panel

    FAMILY Wellness

    Antifungal

    Miconazorb AF

    Powder

    Miconazole Nitrate 2%

    Talc-Free

    • Cures most athlete's foot, jock itch & ringworm
    • Relieves chafing, itching, burning & scaling
    • Absorbs moisture

    Net wt 2.5 OZ (71 g)

    miconazorb anti-fungal powder talc-free

  • INGREDIENTS AND APPEARANCE
    MICONAZOLE NITRATE 
    antifungal miconazorb af powder talc free powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55319-144
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE1.42 g  in 71 g
    Inactive Ingredients
    Ingredient NameStrength
    TRICALCIUM PHOSPHATE (UNII: K4C08XP666)  
    CHLOROXYLENOL (UNII: 0F32U78V2Q)  
    IMIDUREA (UNII: M629807ATL)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    ZEA MAYS SUBSP. MAYS WHOLE (UNII: 1G5HNE09V8)  
    ALLANTOIN (UNII: 344S277G0Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55319-144-7171 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C10/01/2019
    Labeler - Family Dollar Services Inc. (024472631)