Label: ANTIFUNGAL MICONAZOLE- miconazole nitrate aerosol, spray

  • NDC Code(s): 56104-256-01
  • Packager: Premier Brands of America Inc.
  • Category: HUMAN OTC DRUG LABEL

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 January 25, 2023

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  • Active ingredient

    Miconozole nitrate 2%

  • Purpose

    Antifungal

  • INDICATIONS & USAGE

    Uses

    • cures most athlete's foot (tinea pedis), ringworm (tinea corporis) and jock itch (tinea cruris)
    • relieves symtoms of athlete's foot, including itching, burning and cracking
  • Warnings

    For external use only.

    Flammable:

    Do not use while smoking or near heat or flame. Do not puncture or incinerate. Contents under pressure. Do not store at temperature above 120°F. Intentional misuse by deliberately concentrationg and inhaling contents can be harmful or fatal.

    When using this product

    • avoid contact with the eyes or mouth
    • use only as directed

    Stop use and ask a doctor if

    • irritation occurs
    • no improvement within 4 weeks for athlete's foot and ringworm; 2 weeks for jock itch

    Do not use

    on children under 2 years of age unless directed by a doctor.

    Keep out of reach of children

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

  • Directions

    • wash affected area and dry thoroughly
    • shake can well and spray a thin layer 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 toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily
    • use daily for 4 weeks for athlete's foot and ringworm; use daily for 2 weeks for jock itch; if condition persists, consult a doctor
    • this product is not effective on scalp or nails
    • if nozzle clogs, clean with a pin
  • Other infomation

    store between 20 o and 30 o C (68 o and 86 oF)

  • Inactive ingredients

    disteardimonium hectorite, isobutane, kaolin, SD alcohol 40-B, zea mays (corn) starch

  • Questions

    Call 1-866-964-0939

  • PRINCIPAL DISPLAY PANEL

    Athlete's Foot Antifungal Powder Spray

    Miconazole Nitrate 2%/

    ANTIFUNGAL

    Cures Most Athelete's Foot

    Relieves Itching, Cracking & Burning

    Talc Free

    NET WT. 4.6 OZ (130g)

    image 1

  • INGREDIENTS AND APPEARANCE
    ANTIFUNGAL MICONAZOLE 
    miconazole nitrate aerosol, spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:56104-256
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE2.6 g  in 130 g
    Inactive Ingredients
    Ingredient NameStrength
    ISOBUTANE (UNII: BXR49TP611)  
    ALCOHOL (UNII: 3K9958V90M)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    ZEA MAYS SUBSP. MAYS WHOLE (UNII: 1G5HNE09V8)  
    KAOLIN (UNII: 24H4NWX5CO)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:56104-256-01130 g in 1 CANISTER; Type 0: Not a Combination Product11/02/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C09/29/2021
    Labeler - Premier Brands of America Inc. (117557458)
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